ABIVAX Société Anonyme (Abivax) operates as a clinical-stage biopharmaceutical company.
The company has one wholly owned subsidiary, Abivax LLC, a Delaware limited liability company, formed on March 20, 2023.
The company is focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. The company is evaluating its lead drug candidate, obefazimod, in Phase 3 clinical trials for the treatm...
ABIVAX Société Anonyme (Abivax) operates as a clinical-stage biopharmaceutical company.
The company has one wholly owned subsidiary, Abivax LLC, a Delaware limited liability company, formed on March 20, 2023.
The company is focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. The company is evaluating its lead drug candidate, obefazimod, in Phase 3 clinical trials for the treatment of adults with moderately to severely active ulcerative colitis (‘UC’). The company is also in the planning stages of initiating a Phase 2b clinical trial of obefazimod in patients with Crohn’s disease (‘CD’), as well as evaluating other potential inflammatory indications.
The company focuses on indications where existing treatments have left patients with significant unmet needs, and where the company’s investigational agents have the potential to be meaningfully differentiated from available therapies. The indications the company targets have substantial populations and represent large commercial opportunities, pending regulatory approvals and successful commercialization. The company’s initial focus is on inflammatory bowel diseases (‘IBD’), chronic conditions involving inflammation of the gastrointestinal (‘GI’) tract, of which the two most common forms are UC and CD. As of 2022, an aggregate of approximately 2.9 million patients across the United States, EU4 (France, Germany, Italy and Spain), the United Kingdom and Japan suffered from IBD, with 1.5 million of these patients in the United States alone.
The company’s lead drug candidate, obefazimod, is differentiated from competing approaches for the treatment of IBD via its novel mechanism of action. Obefazimod was demonstrated to specifically enhance the expression of a single micro-RNA, miR-124, which plays a critical role in the regulation of the inflammatory response. In the context of inflammation, miR-124 is a natural regulator of the inflammatory response, controlling progression of inflammation and restoring homeostasis of the immune system, without causing broader immunosuppression. In contrast to available advanced therapies, prescribed post-conventional therapies, some of which target only a single cytokine or pathway, miR-124 modulates the expression of several key cytokines and pathways. Modulating multiple inflammatory pathways simultaneously may lead to more durability of efficacy results over the long-term, which is critical in lifelong conditions such as IBD, potentially differentiating obefazimod from available IBD treatments.
In the company’s Phase 2 clinical trials for the treatment of moderately to severely active UC, consistent with the pharmacological effects observed in the company’s preclinical studies, obefazimod demonstrated an onset of symptom relief by day 8 of dosing, with meaningful reductions in rectal bleeding and stool frequency scores. In the company’s induction Phase 2b clinical trial, which included 252 patients, obefazimod met the primary endpoint of a statistically significant reduction in Modified Mayo Score, a measure of disease activity relative to placebo. In addition, the company observed high rates of sustained and newly achieved clinical remission in the subsequent open-label maintenance extension trial of up to two years of treatment, of which approximately 45% of patients were previously exposed to biologics or Janus kinase (‘JAK’) inhibitors. Greater than 90% of patients previously exposed to advanced therapy prior to enrollment were highly refractory, having failed two advanced therapies.
In April 2023, the company reported the results from the final analysis of the company’s Phase 2b open-label maintenance trial, including 217 patients of which 164 patients (76%) completed the second year of once-daily oral treatment with 50 mg obefazimod. At the conclusion of the second year of treatment, 114 of the 217 patients enrolled (53%) achieved clinical remission and 158 patients (73%) achieved clinical response. Among the 98 bio-refractory patients, 66 patients (67%) had a clinical response, 38 patients (39%) were in clinical remission, 46 patients (47%) had endoscopic improvement and 20 patients (20%) had endoscopic remission at week 96. Among the 124 patients that achieved clinical response at the end of the 8-week induction period of the double-blind study, 82 patients (66%) achieved clinical remission at week 48, mimicking the re-randomization of responders approach typically utilized in Phase 3 maintenance trials. Of the 124 patients in clinical response at week 8, 74 patients (60%) achieved clinical remission, 95 patients (77%) had clinical response, 79 patients (64%) achieved endoscopic improvement and 52 patients (42%) achieved endoscopic remission at week 96.
In September 2023, the company reported an interim analysis of step-down dosing from 50 mg to 25 mg for the third and fifth year of open-label maintenance treatment with obefazimod in UC patients. These patients were treated with 50 mg of oral, once-daily obefazimod for approximately four years in the Phase 2a clinical trial and approximately two years in the Phase 2b clinical trial. Patients were eligible to enroll in the trial if they had a Mayo endoscopic subscore of 0 or 1. Eligible patients were switched to 25 mg, and an interim analysis was performed at week 48 with a cut-off date of July 31, 2023. Of the 71 eligible patients, 63 completed their 48-week visit. Among these patients, 53 out of 63 patients (84%) demonstrated disease control (stable or improved Modified Mayo Score). No new safety signals were detected in UC patients treated up to five years with oral, once-daily obefazimod.
Obefazimod’s tolerability profile indicates potentially important clinical differentiation. As of November 30, 2023 (the last safety data cut-off date), 1,082 subjects have received obefazimod, according to various administration schedules, in all completed and ongoing open-label clinical trials across all indications including 248 subjects for longer than 6 months and 226 subjects for longer than one year. Additionally, 146 subjects included in the ABTECT program have received blinded obefazimod or placebo.
The company initiated its pivotal Phase 3 clinical trials of obefazimod for the treatment of moderately to severely active UC in October 2022, which consist of two induction trials (ABTECT-1 and ABTECT-2) and one ABTECT maintenance trial. Top-line data from the ABTECT-1 and ABTECT-2 induction trials is expected to be announced in the first quarter of 2025, and top-line data from the ABTECT maintenance trial is expected to be announced in the first quarter of 2026. The company’s Investigational New Drug application (‘IND’) for a Phase 2b clinical trial in patients with CD was cleared by the FDA in the fourth quarter of 2023, and the company expects to initiate enrollment in the third quarter of 2024. The company intends to announce Phase 2b induction trial top-line results in the second half of 2026 with the objective to demonstrate clinical response and tolerability profile consistent with that already observed in the company’s clinical trials for moderately to severely active UC. Based on the results from this Phase 2b clinical trial, if positive, the company intends to proceed to a Phase 3 clinical trial.
Pipeline
The company’s lead drug candidate, obefazimod, is in clinical development for the treatment of moderately to severely active UC. The company is continuing to develop obefazimod for the treatment of CD and are evaluating additional potential inflammatory indications to pursue, subject to the availability of necessary resources and funding. In parallel, the company is in the process of generating follow-on compounds based on the miR-124 platform.
Strategy
The company focuses on indications with high unmet needs with substantial commercial potential. The company is pursuing the following key elements of the company’s strategy: advancing obefazimod through pivotal clinical trials and establishing obefazimod as a potential first-line advanced therapy for IBD; potential combination therapy in IBD with obefazimod; leveraging library of miR-124 enhancers to expand the company’s pipeline in chronic inflammatory diseases; and opportunistically evaluating strategic partnerships to maximize the value of obefazimod and the company’s therapeutic pipeline.
Programs
The company’s lead drug candidate, obefazimod, is in clinical development for the treatment of moderately to severely active UC. The company is continuing to develop obefazimod for the treatment of CD and are evaluating additional potential inflammatory indications to pursue, subject to the availability of necessary resources and funding. In parallel, the company is in the process of generating follow-on compounds based on the miR-124 platform.
The company’s Lead Drug Candidate for the Treatment of Inflammatory Diseases: Obefazimod
Obefazimod is an oral small molecule drug candidate in clinical development for the treatment of moderately to severely active UC. Obefazimod is the only small molecule drug candidate in clinical development with a mechanism of action that was demonstrated to specifically enhance the expression of a single micro-RNA, miR-124, which plays a critical role in the regulation of the inflammatory response. In the company’s induction Phase 2b clinical trial, which included 252 patients, obefazimod met the primary endpoint of a statistically significant reduction in Modified Mayo Score, a measure of disease activity relative to placebo. The company has observed an onset of symptom relief by day 8 of dosing, with meaningful reductions in rectal bleeding and stool frequency scores, consistent with the pharmacological effects observed in the company’s preclinical studies, and high rates of sustained and newly achieved clinical remission in the subsequent open-label maintenance extension trial of up to two years of treatment, of which approximately 45% of patients were previously exposed to biologics or JAK inhibitors.
In April 2023, the company reported the results from the final analysis of the company’s Phase 2b open-label maintenance trial, including 217 patients of which 164 patients (76%) completed the second year of once-daily oral treatment with 50 mg obefazimod. At the conclusion of the second year of treatment, 114 of the 217 patients enrolled (53%) achieved clinical remission and 158 patients (73%) achieved clinical response. Among the 98 bio-refractory patients, 66 patients (67%) had a clinical response, 38 patients (39%) were in clinical remission, 46 patients (47%) had endoscopic improvement and 20 patients (20%) had endoscopic remission at week 96. Among the 124 patients that achieved clinical response at the end of the 8-week induction period of the double-blind study, 82 patients (66%) achieved clinical remission at week 48, mimicking the re-randomization of responders approach typically utilized in Phase 3 maintenance trials. Of the 124 patients in clinical response at week 8, 74 patients (60%) achieved clinical remission, 95 patients (77%) had clinical response, 79 patients (64%) achieved endoscopic improvement and 52 patients (42%) achieved endoscopic remission at week 96.
In September 2023, the company reported an interim analysis of step-down dosing from 50 mg to 25 mg for the third and fifth year of open-label maintenance treatment with obefazimod in UC patients. These patients were treated with 50 mg of oral, once-daily obefazimod for approximately four years in the Phase 2a clinical trial and approximately two years in the Phase 2b clinical trial. Patients were eligible to enroll in the trial if they had a Mayo endoscopic subscore of 0 or 1. Eligible patients were switched to 25 mg, and an interim analysis was performed at week 48 with a cut-off date of July 31, 2023. Of the 71 eligible patients, 63 completed their 48-week visit. Among these patients, 53 out of 63 patients (84%) demonstrated disease control (stable or improved Modified Mayo Score). No new safety signals were detected in UC patients treated up to five years with oral, once-daily obefazimod.
Furthermore, obefazimod’s tolerability profile indicates potentially important clinical differentiation. As of November 30, 2023 (the last safety data cut-off date), 1,082 subjects have received obefazimod, according to various administration schedules, in all completed and ongoing open-label clinical trials across all indications, including 248 subjects for longer than 6 months and 226 subjects for longer than one year. The most common treatment emergent adverse event (‘TEAE’) reported has been mild to moderate headache, which has been transient and manageable with or without over-the-counter medications. Furthermore, at present and based on data from all completed or non- blinded clinical trials with obefazimod, no increased rate of opportunistic infections or malignancies have been observed. The company expects to announce its UC extension trial data read-out after one and two years of continued treatment with reduced dose of 25 mg of obefazimod in the third quarter of 2024.
The company initiated its pivotal Phase 3 clinical trials of obefazimod for the treatment of moderately to severely active UC in consultation with international regulators, including the U.S. Food and Drug Administration (the ‘FDA’), the EMA, the Pharmaceuticals and Medical Devices Agency (‘PMDA’) and the China Center for Drug Evaluation (‘CDE’). These pivotal Phase 3 clinical trials consist of two induction trials (ABTECT-1 and ABTECT-2) and one ABTECT maintenance trial in doses of 25 mg and 50 mg across 36 countries in North America, Latin America, Europe, and the Asia Pacific, involving 1,200 moderately to severely active UC patients in over 600 sites. Each of the trials will be randomized, double-blind and placebo-controlled, using independent and central review of video-taped endoscopies with the primary endpoint of clinical remission according to the Modified Mayo Score assessed at week 8 (induction) and at week 44 (maintenance), as recommended by the FDA. Enrollment of the first patient under this program occurred on October 11, 2022. Top-line data from the ABTECT-1 and ABTECT-2 induction trials is expected to be announced in the first quarter of 2025, and top-line data from the ABTECT maintenance trial is expected to be announced in the first quarter of 2026. The company expects to complete enrollment for its induction trials in the fourth quarter of 2024.
The obefazimod safety database is supported by more than 1,000 subjects treated with obefazimod across different indications, including UC patients, some of whom are in their fifth year of continuous daily dosing.
Obefazimod in UC
In September 2021, the FDA published strict warnings about increased risk of serious heart-related events, cancer, blood clots and death for JAK inhibitors that treat certain chronic inflammatory conditions (including UC). In January 2023, the EMA stated recommendations to minimize the risk of serious side effects with JAK inhibitors used to treat several chronic inflammatory disorders, noting that these side effects include cardiovascular conditions, blood clots, cancer and serious infections which were adopted by the European Commission in March 2023.
Obefazimod is being developed as a once-daily, oral medication which, combined with its observed tolerability to date, would represent a meaningfully differentiated clinical profile from existing therapies. This may position obefazimod as a potential first-line advanced therapy choice for both prescribers and patients, if approved.
Clinical Trial Results of Obefazimod in Moderately to Severely Active UC
As of November 30, 2023 (the last safety data cut-off date), 1,082 subjects have received obefazimod, according to various administration schedules, in all completed and ongoing open-label clinical trials across all indications, including 248 subjects for longer than 6 months and 226 subjects for longer than one year. The most common TEAE reported has been mild to moderate headache, which has been transient and manageable with or without over-the-counter medications. Furthermore, at present and based on data from all completed or non-blinded clinical trials with obefazimod, no increased rate of opportunistic infections or malignancies have been observed. The company is conducting Phase 3 clinical trials in moderately to severely active UC in the United States, Europe, the Asia Pacific and Latin America.
Phase 2a Clinical Trial with Obefazimod for the Treatment of Moderately to Severely Active UC
The induction Phase 2a clinical trial was a randomized trial of an 8-week placebo-controlled, double-blind induction phase followed by an open-label long term extension trial. It was completed in September 2018. This proof-of-concept trial enrolled 32 adult patients who had been diagnosed with moderately to severely active UC for at least 12 weeks and who failed or were intolerant to conventional treatments (50%) or biologics (50%). Patients who completed the induction phase were eligible to continue in the open-label extension trial.
In the induction phase, patients were randomized two-to-one to a once-daily orally-administered 50 mg dose of obefazimod or placebo for eight weeks. In the long-term extension, all patients received a once-daily orally-administered 50 mg dose of obefazimod.
This double-blind, placebo-controlled trial follows a standard study design in this indication for which a dose response as well as placebo effect can be frequently observed. The 50 mg daily dose was selected on the basis of the safety data accumulated for this dose.
Overview of Primary Endpoints of Induction Phase 2a Clinical Trial with Obefazimod for the Treatment of UC
The primary endpoint in the induction Phase 2a clinical trial was safety, assessed as the rate of TEAEs. The primary endpoint in the induction phase, evaluation of safety and tolerability of obefazimod, was met. The most frequently reported adverse events reported in the 50 mg group were GI disorders and headache. GI disorders were experienced by 35% of subjects in the obefazimod group and 22% of subjects in the placebo group. These included abdominal pain, abdominal pain upper, anal fissure, anorectal discomfort, dyspepsia and nausea for the obefazimod group and abdominal pain and diarrhea for the placebo group. Headache was experienced by 17% of subjects in the obefazimod group and 0% in the placebo group. Headaches occurred early and were transient (lasting only a few days), mainly mild or moderate (grade 1 or 2) and manageable with or without over-the-counter medications. No serious adverse events related to treatment were observed.
Overview of Secondary Endpoints of Induction Phase 2a Clinical Trial with Obefazimod for the Treatment of UC
The secondary endpoints in the induction Phase 2a clinical trial included the proportion of patients achieving clinical remission at week 8 as compared to placebo, change from baseline to week 8 in total Modified Mayo Score (which is based on stool frequency, rectal bleeding, physician global assessment and endoscopic subscore), rate of endoscopic improvement, clinical response rate, as well as miR-124 expression in the rectal tissue of the patients.
Overview of Additional Follow-Up Data from Long Term Extension Portion of Phase 2a Clinical Trial with Obefazimod for the Treatment of Moderately to Severely Active UC
For the long-term extension, the primary objective was long term safety of obefazimod. Additional efficacy endpoints included clinical and endoscopic rates of response and remission. Overall, 32 patients were enrolled in the induction phase, 23 patients were randomized to obefazimod, and nine patients were randomized to placebo. Of the 29 patients who completed the induction phase (20 patients for obefazimod and nine patients for placebo), 22 patients continued their treatment into the long-term extension. In October 2019, the company announced the 12-month data from this Phase 2a proof-of-concept trial. This open-label maintenance trial was conducted in 22 patients, of which 19 completed the first year of treatment. At 12 months, an endoscopy was performed in 16 of the 19 patients to evaluate the rate of clinical remission, and 12 of the 16 evaluable patients (75%) were observed to achieve clinical remission. Obefazimod was also observed to maintain enhanced expression of miR-124 throughout the 12 months of the trial. At month 12, mean change in Mayo Score was observed at -2.6 points compared to the maintenance baseline. Median fecal calprotectin decreased from 153.1 microg/g (baseline) to 27.9 microg/g and 31.6 microg/g at week 52 and month 24, respectively.
Phase 2b Clinical Trial with Obefazimod for the Treatment of UC
Overview of Induction Phase 2b Clinical Trial with Obefazimod for the Treatment of UC
The induction Phase 2b clinical trial for the treatment of moderately to severely active UC was conducted in 252 patients enrolled at 130 trial sites across 15 European countries, Canada and the United States. It was completed in April 2021. The trial was a randomized, double-blind and placebo-controlled 16-week induction trial with a primary efficacy endpoint at week 8 involving four treatment groups (receiving an oral once-daily 25 mg, 50 mg or 100 mg dose of obefazimod or placebo). Endoscopies were read centrally and blinded, by independent reviewers. Electronic patient diaries were used to enhance the reliability of the collection of stool frequency, rectal bleedings, and other patient reported outcomes-all efficacy endpoints were set according to FDA guidance.
Overview of Primary Endpoints of Induction Phase 2b Clinical Trial with Obefazimod for the Treatment of UC
The company also conducted sub-group analyses of biologics / JAK-naïve and biologics / JAK-experienced patients.
Overview of Maintenance Phase 2b Clinical Trial with Obefazimod for the Treatment of UC
Of the 222 patients who completed the 16-week Phase 2b induction trial, 217 patients (98%) enrolled in the subsequent open-label maintenance trial to evaluate the induction Phase 2b clinical trial long-term safety and efficacy profile of obefazimod for up to two years, irrespective of treatments or treatment outcome during the induction phase.
During the induction and the maintenance treatments of the Phase 2b clinical trial, the safety and tolerability profile observed was consistent with previous findings and no new adverse safety signals were observed. As of November 30, 2023 (the last safety data cut-off date), 1,082 subjects have received obefazimod, according to various administration schedules, in all completed and ongoing open-label clinical trials across all indications, including 248 subjects for longer than 6 months and 226 subjects for longer than one year.
Overview of Phase 2 Open-Label Trial to Evaluate Long-Term Safety and Efficacy of Obefazimod at 25 mg
In September 2023, the company reported an interim analysis of step-down dosing from 50 mg to 25 mg for the third and fifth year of open-label maintenance treatment with obefazimod in UC patients.
These patients were treated with 50 mg of oral, once-daily obefazimod for approximately four years in the Phase 2a clinical trial and approximately two years in the Phase 2b clinical trial. Patients were eligible to enroll in the trial if they had a Mayo endoscopic subscore of 0 or 1. Eligible patients were switched to 25 mg, and an interim analysis was performed at week 48 with a cut-off date of July 31, 2023.
Phase 3 Clinical Trials and Regulatory Pathway in UC
The company is working with IQVIA, a global premier contract research organization, to conduct the Phase 3 clinical trials with obefazimod in moderately to severely active UC, following consultations with regulatory agencies, including FDA, EMA, CDE and PMDA.
These pivotal Phase 3 clinical trials consist of two induction trials (ABTECT-1 and ABTECT-2) and the subsequent ABTECT maintenance trial investigating obefazimod at doses of 25 mg and 50 mg across 36 countries in North America, Latin America, Europe and Asia Pacific, involving 1,200 moderately to severely active UC patients in over 600 sites. Each of the trials will be randomized, double-blind and placebo-controlled, using independent and central review of the video-taped endoscopies with the primary endpoint of clinical remission according to the Modified Mayo Score assessed at week 8 (induction) and at the end of the 44-week maintenance trial (total 52 weeks), as recommended by the FDA.
Enrollment of the first patient under this program in the United States occurred on October 11, 2022. Top-line data from the ABTECT-1 and ABTECT-2 induction trials is expected to be announced in the first quarter of 2025, and top-line data from the ABTECT maintenance trial is expected to be announced in the first quarter of 2026.
Additional Clinical Trials Completed with Obefazimod
In addition, four Phase 1 clinical trials have recently been completed to assess the tolerability and safety profile of obefazimod: (i) a Phase 1 heart rhythm (QT interval) trial, for which the company enrolled 120 healthy volunteers; (ii) a Phase 1 clinical trial of drug-drug interactions, for the purposes of providing further information on any possible interactions of obefazimod with other drugs, for which the company enrolled 60 healthy volunteers; (iii) a Phase 1 absorption, distribution, metabolism and excretion trial for the purposes of generating additional data to further evaluate the safety profile of obefazimod, for which the company enrolled 12 healthy volunteers; and (iv) a Phase 1 clinical trial conducted in Japanese subjects to further evaluate pharmacokinetics and tolerability of obefazimod in this population, for which the company enrolled 48 healthy volunteers. The results of these Phase 1 clinical trials provide supportive data for the company’s further clinical development and New Drug Application (‘NDA’) submission. Furthermore, additional Phase 1 clinical trials to support NDA submission are planned. While the company has decided not to pursue additional clinical work in RA at this point, the company has completed a Phase 2a clinical trial in patients with RA, where the company saw encouraging proof-of-concept data supporting obefazimod’s potential role in addressing inflammatory conditions beyond IBD.
Obefazimod in CD
Similar to existing UC treatments, patients may receive oral immunosuppressants, such as azathioprine and methotrexate as well as short courses of corticosteroids. In cases of moderately to severely active CD, the options for advanced therapy include very commonly prescribed TNF-alpha inhibitors, anti-integrin antibodies, IL-12/23 inhibitors, IL-23 inhibitors and JAK inhibitors. Therapies such as TNF-alpha inhibitors, IL-12/23 inhibitors or IL-23 inhibitors are injectable agents, representing a significant commercial disadvantage due to patients’ and prescribers’ preference for the convenience of oral therapies. JAK inhibitors are accompanied by safety warnings due to increased risk of adverse events such as infection, cancer or blood clots.
Proposed Obefazimod CD Development Program
Due to the pathophysiological and clinical similarities of CD and UC, the company plan to initiate a Phase 2b clinical trial in patients with CD in the third quarter of 2024 to potentially demonstrate outcomes consistent with those observed in the company’s Phase 2 clinical trials for moderately to severely active UC. The nonclinical and Phase 1 data generated in the company’s UC clinical trials are sufficient to support initiation of this Phase 2b trial in CD. The company filed an IND in the fourth quarter of 2023 to initiate a single-dose Phase 2a proof-of-concept trial. Following further consultation, the FDA permitted the company to use a more efficient path in the dose exploration Phase 2b design. The company intends to announce Phase 2b induction trial top-line results in the second half of 2026. Based on the results from this Phase 2b clinical trial, the company intends to proceed to Phase 3 clinical trials.
Potential Combination Therapy for the Treatment of IBD with Obefazimod as the Cornerstone
The company has initiated a formal process evaluating oral and injectable combination therapy candidate with obefazimod in UC. Preclinical data to support the company’s decision-making on a combination agent is expected during the second half of 2024.
Follow-On Compounds Program
Based on the mechanistic concept of obefazimod, a research and development program is ongoing to generate new potential drug candidates to strengthen the company’s intellectual property portfolio on the miR-124 platform. The first follow-on drug candidate is expected to be selected during the third quarter of 2024.
Competition
The company’s competitors in the chronic inflammatory disease field are primarily large pharmaceuticals companies, including but not limited to, AbbVie, Eli Lilly, Johnson & Johnson, Pfizer, and Takeda.
Intellectual Property
One of the company’s strategies is also to file new patents that could extend obefazimod’s intellectual property protection in the United States to 2039 and to generate new intellectual property through the protection of potential follow-on compounds.
Patents
All the patents and patent applications covering obefazimod are co-owned with the French National Centre for Scientific Research (the ‘CNRS’), the University of Montpellier, and the Institut Curie, except U.S. patent 10,464,903 and U.S. patent 10,745,357, as described below.
Obefazimod
As of December 31, 2023, the principal patent rights related to obefazimod, included:
U.S. patent 10,017,498, which is directed to the composition of matter of obefazimod generically and specifically and to a pharmaceutical composition comprising it. This patent is also granted in Europe and several other countries (Australia, Brazil, Canada, China, Hong Kong, Cuba, India, Japan, South Korea, Mexico, Russia, South Africa) and has an expiry date of 2030, not including patent term adjustment or any potential PTE.
U.S. patent 10,975,063, which is directed specifically to obefazimod (composition of matter), free base and salts of obefazimod, a pharmaceutical composition comprising it, a process for preparing it and a method for treating HIV infection. This patent has an expiry date of 2030, not including patent term adjustment or any potential PTE.
U.S. patent 10,435,370, which is directed to methods of treating inflammatory diseases, including UC and CD by obefazimod generically and specifically. This patent is also granted in Europe and several other countries.
U.S. continuation patent 11,649,211 is directed to the method of treating inflammatory diseases, including UC and CD by obefazimod specifically. Divisional U.S. patents protect methods of treating additional inflammatory diseases (U.S. patent 10,981,874 and U.S. patent 11,649,210). These patents have an expiry date of 2035, not including patent term adjustment or any potential PTE.
U.S. patent 10,464,903 and U.S. patent 10,745,357, which are directed to a synthesis process for manufacturing obefazimod and derivatives thereof, a polymorphic form of the free base of obefazimod and crystalline forms of various salts of obefazimod. These patents have an expiry date of 2037, not including patent term adjustment or any potential PTE. A corresponding European patent has also been granted. These patents are solely owned by the company.
Further indications are also protected by other patents: U.S. patent 9,827,237, which is directed to the method of treating Human Leukemia virus infection. This patent is also granted in Europe and several other countries and has an expiry date of 2034. U.S. patent 9,145,367, which is directed to the method of treating AIDS by obefazimod generically and specifically. This patent is also granted in Europe and several other countries and has an expiry date of 2030. U.S. patent 9,108,919, which is directed to the method of treating cancer by obefazimod generically and specifically. This patent is also granted in Europe and several other countries and has an expiry date of 2030. Another patent application directed to a method of treating cancer has been filed worldwide in 2019. U.S. patent 10,806,729 which is directed to the method of treating HIV resistant patients by obefazimod generically and specifically. This patent is also granted in Europe and other countries and has an expiry date of 2036.
U.S. patent applications 17/416,856 and 17/416,679, which are respectively directed to the method of treating other inflammatory diseases and cancer by obefazimod generically and specifically or its N-glucuronide metabolite have been filed in 2019, as well as counterpart applications in other countries.
U.S. patent application 17/913,063, which is directed to the method of treating Coronaviridae infection by obefazimod generically and specifically or its N-glucuronide metabolite has been filed in 2021, as well as counterpart applications in other countries.
U.S. patent application 17/796,834, which is directed to the amorphous solid dispersion (ASD) of obefazimod, its method of preparation, pharmaceutical composition and method of treating inflammatory disease, cancer and viral diseases therewith has been filed in 2021, as well as counterpart applications in other countries.
U.S. patent application 17/793,133, which is directed to co-crystals and salts of obefazimod, pharmaceutical composition and method of treating inflammatory disease, cancer and viral diseases therewith has been filed in 2021, as well as counterpart applications in other countries.
U.S. patent application18/284,253, which is directed to a synthesis process for manufacturing obefazimod and derivatives thereof and was filed in 2022.
Two PCT international patent applications filed in 2023 were published underWO23/135207 directed to combinations products with obefazimod respectively with etrasimod and Rinvoq.
Trademarks and Domain Names
The company owns a number of registered and pending trademarks and registered domain names. The URL for the company’s website, as well as a number of domain names including the wording ‘abivax’ or ‘obefazimod’. ‘Abivax’ is a registered trademark of the company’s company in Australia, Brazil, Canada, Cuba, the EU, France, India, South Africa, the United Kingdom, and the United States. The ‘Abivax’ trademark is pending in Canada, China, India, Japan, Mexico, South Africa, South Korea, and the United States.
Research and Development
For the year ended December 31, 2023, the company’s research and development expenses were €103.2 million.
History
ABIVAX Société Anonyme was founded in 2013. The company was incorporated as a societe anonyme (limited liability company) under the laws of France in 2013.
