Drugs / Obefazimod
Obefazimod
Trials 21
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT07453784 | Mar → Sep 2026 overdue | — | Abivax S.A. | Recruiting | No outcome recorded |
| Phase 1 | NCT05032560 | Sep 2021 → Feb 2022 | — | Abivax S.A. | Completed | No outcome recorded |
| Phase 1 | NCT05121714 | Dec 2020 → May 2021 | — | Abivax S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02731885 | Sep 2014 → Jun 2015 | — | Abivax S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02792686 | Mar → Jul 2014 | — | Abivax S.A. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02990325 | Mar 2017 → Dec 2018 | HIV infectious disease | Abivax S.A. | Completed | No outcome recorded |
| Phase 210 trials · 2 met primary | ||||||
| Phase 2 | NCT06456593 | Oct 2024 → Dec 2026 expected | Crohn jejunoileitis | Abivax S.A. | Recruiting | No outcome recorded |
| Phase 2 | NCT05177835 | Dec 2021 → Mar 2028 expected | ulcerative colitis | Abivax S.A. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04023396 | Jan 2020 → Feb 2023 | ulcerative colitis | Abivax S.A. | Completed | No outcome recorded |
| Phase 2 | NCT04049448 | Oct 2019 → Jan 2023 | rheumatoid arthritis | Abivax S.A. | Completed | No outcome recorded |
| Phase 2 | NCT03760003 | Aug 2019 → Apr 2021 | ulcerative colitis | Abivax S.A. | Completed | Met primary |
| Phase 2 | NCT03813199 | Jul 2019 → Apr 2021 | rheumatoid arthritis | Abivax S.A. | Completed | Met primary |
| Phase 2 | NCT03368118 | Jan 2018 → Jul 2022 | ulcerative colitis | Abivax S.A. | Completed | No outcome recorded |
| Phase 2 | NCT03093259 | Nov 2017 → Jul 2018 | ulcerative colitis | Abivax S.A. | Completed | No outcome recorded |
| Phase 2 | NCT02735863 | May 2016 → Aug 2017 | HIV infectious disease | Abivax S.A. | Completed | No outcome recorded |
| Phase 2 | NCT02452242 | Jan → Dec 2015 | HIV infectious disease | Abivax S.A. | Completed | No outcome recorded |
| Phase 2/32 trials · 1 missed | ||||||
| Phase 2/3 | NCT03905109 | Sep 2022 | Crohn disease | Abivax S.A. | Withdrawn | No outcome recorded |
| Phase 2/3 | NCT04393038 | Jul 2020 → Mar 2021 | COVID-19 | Abivax S.A. | Terminated | Missed primary |
| Phase 33 trials · 2 met primary | ||||||
| Phase 3 | NCT05507216 | Jan 2023 → Jun 2025 | ulcerative colitis | Abivax S.A. | Completed | Met primary |
| Phase 3 | NCT05535946 | Jan 2023 → Apr 2026 overdue | ulcerative colitis | Abivax S.A. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05507203 | Nov 2022 → Jun 2025 | ulcerative colitis | Abivax S.A. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 64
| Date | Issuer | Release |
|---|---|---|
| 2026-06-29 | Abivax S.A. | Results Abivax Reports Positive ABTECT Maintenance Part 2 Results for Obefazimod, Demonstrating Meaningful Clinical Benefit in Refractory Ulcerative Colitis Patients and Strengthening the Phase 3 Maintenance Safety Database abivax.com ↗
Obefazimod delivered meaningful clinical benefit in a highly refractory ulcerative colitis (“UC”) population, with 37.2% of induction non-responders achieving clinical remission and 34.5% achieving endoscopic remission at Week 44 following continued 50 mg treatment |
| 2026-06-01 | Abivax S.A. | Results Abivax Announces Landmark Phase 3 ABTECT Maintenance Trial Results Evaluating Obefazimod in Moderately to Severely Active Ulcerative Colitis abivax.com ↗ |
| 2026-05-22 | Abivax S.A. | Results Abivax Presents First Quarter 2026 Financial Results and Reports Three-Year Interim Data from Study 108, a Phase 2a/2b Open-Label Extension Trial of Obefazimod Following Dose De-Escalation in Patients with Ulcerative Colitis abivax.com ↗
Following two to four years of open-label treatment with 50 mg, 130 patients de-escalated to 25 mg, and at week 144, 68% (88/130) were in clinical remission and 80% (104/130) completed 144 weeks of treatment |
| 2026-02-21 | Abivax S.A. | Results Abivax Presents First Evidence of Anti-Fibrotic Activity for Obefazimod Alongside New Clinical Efficacy and Safety Analyses in Inflammatory Bowel Disease at ECCO 2026 abivax.com ↗
Anti-fibrotic effects of obefazimod were observed in both a preclinical human fibroblast model and in an in vivo animal model, suggesting potential to address a major unmet need in Crohn’s disease |
| 2025-11-03 | Abivax S.A. | Results Abivax Announces Patient-Reported Outcomes Data from the Phase 3 ABTECT Induction Trials of Obefazimod, Demonstrating Significant Improvements in Quality of Life for Patients with Moderate-to-Severely Active Ulcerative Colitis abivax.com ↗
Abivax SA (Euronext Paris: FR0012333284 – ABVX / Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, today announced patient-reported outcomes (PRO) from its Phase 3 ABTECT 8-week induction trials evaluating obefazimod in adult patients with moderate-to-severely active ulcerative colitis (UC). |
| 2025-10-06 | Abivax S.A. | Results Abivax Announces Late-Breaking Presentation of 8-Week ABTECT Induction Trial Results in Participants With and Without Prior Inadequate Response to Advanced Therapies abivax.com ↗
50 mg dose of once-daily obefazimod achieved clinically meaningful improvements, across all endpoints, regardless of prior inadequate response to advanced therapies |
| 2025-10-05 | Abivax S.A. | Results Abivax Announces Late-Breaking Presentation of 8-Week ABTECT Trial Results with Updated Safety Data abivax.com ↗
The presentation includes results from Abivax’s Phase 3 ABTECT 8-Week Induction Trials investigating obefazimod for the treatment of moderate-to-severely active ulcerative colitis, including previously reported findings and additional safety data at week 8. |
| 2025-07-22 | Abivax S.A. | Results Abivax Announces Positive Phase 3 Results from Both ABTECT 8-Week Induction Trials Investigating Obefazimod, its First-in-Class Oral miR-124 Enhancer, in Moderate to Severely Active Ulcerative Colitis abivax.com ↗
50 mg once-daily dose of obefazimod met all key secondary endpoints demonstrating highly statistically significant and clinically meaningful benefits. |
| 2024-10-03 | Abivax S.A. | Results Abivax Reports Positive Interim Efficacy and Safety Analysis of Once-Daily 25mg Obefazimod in Moderate to Severe Ulcerative Colitis Patients After 2-Years of Open-Label Maintenance abivax.com ↗
The data demonstrated maintenance of clinical remission and a safety profile consistent with prior studies of oral, once-daily obefazimod when administered at a reduced dose of 25mg for up to an additional two years. |
| 2024-09-25 | Abivax S.A. | Results Abivax Provides Update on Ulcerative Colitis (UC) Combination Therapy Program Strategy and Announces Early Preclinical Combination Data of Obefazimod and Etrasimod in Inflammatory Bowel Disease (IBD) Mouse Model abivax.com ↗
Abivax SA (Euronext Paris & Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, announced today results of initial preclinical combination data of obefazimod combined with etrasimod in a mouse model of IBD. |
| 2024-05-08 | Abivax S.A. | Results Abivax announces presentation of four abstracts for obefazimod in ulcerative colitis and preclinical colon cancer model at Digestive Disease Week 2024 abivax.com ↗
We are excited to share new preclinical data showing obefazimod’s impact in reducing the number of tumors in the azoxymethane (AOM)/dextran sodium sulfate (DSS) mouse model of colitis-associated cancer—data in support of obefazimod’s novel mechanism of action. |
| 2024-02-02 | Abivax S.A. | Regulatory Abivax announces update to obefazimod Phase 2b clinical development program in moderately to severely active Crohn’s disease abivax.com ↗
The IND clearance by the FDA allows Abivax to move forward with the development of obefazimod for the treatment of Crohn’s disease. |
| 2023-04-17 | Abivax S.A. | Results Abivax reports two-year efficacy and safety data of obefazimod phase 2b maintenance trial in ulcerative colitis abivax.com ↗
These two-year maintenance results are a strong confirmation of obefazimod’s potential to swiftly induce and, more importantly, maintain long-term efficacy in patients with moderate to severe ulcerative colitis. |
| 2023-01-05 | Abivax S.A. | Results Abivax publishes novel data with respect to obefazimod’s anti-inflammatory mechanism of action abivax.com ↗
The publication highlights obefazimod’s novel mechanism of action (MoA) and its capacity to treat patients with moderate to severe UC. |
| 2022-12-20 | Abivax S.A. | Regulatory Abivax receives FDA agreement on pediatric development plan with obefazimod in IBD abivax.com ↗
today announced that the US Food and Drug Administration (the FDA) provided their agreement on the initial Pediatric Study Plan (iPSP) for the development of obefazimod in ulcerative colitis in children from 2 to 17 years old. |
| 2022-09-06 | Abivax S.A. | Results Abivax phase 2b study results of obefazimod (ABX464) in ulcerative colitis published in the Lancet Gastroenterology & Hepatology abivax.com ↗
The publication highlights that all doses of obefazimod tested during the induction study (25mg, 50mg and 100mg) significantly improved the condition of patients suffering from moderate to severe, active ulcerative colitis compared to placebo, as measured by changes in Modified Mayo Score[3] from baseline at week 8. |
| 2022-06-01 | Abivax S.A. | Results Abivax phase 2a study results of obefazimod (ABX464) in rheumatoid arthritis published in the journal “Annals of the Rheumatic Diseases” and selected for presentation at EULAR 2022 abivax.com ↗ |
| 2022-04-06 | Abivax S.A. | Results Abivax reports excellent one-year efficacy and safety data of ABX464 phase 2b maintenance trial in ulcerative colitis abivax.com ↗
Abivax SA (Euronext Paris: FR0012333284 – ABVX), a clinical-stage biotechnology company developing novel therapies that modulate the immune system to treat chronic inflammatory diseases, viral infections, and cancer, today reports excellent results from the Interim Analysis of its phase 2b open-label maintenance study, including 217 patients who completed the one year of once-daily oral treatment with 50mg ABX464. |
| 2022-03-10 | Abivax S.A. | Results Abivax reports promising ABX464 phase 2a one-year maintenance results in rheumatoid arthritis abivax.com ↗
Abivax SA (Euronext Paris: FR0012333284 – ABVX), a clinical-stage biotechnology company developing novel therapies that modulate the immune system to treat chronic inflammatory diseases, viral infections, and cancer, today reports promising results from its phase 2a maintenance trial in rheumatoid arthritis (RA) after one year of continued daily treatment with 50mg ABX464. |
| 2022-02-08 | Abivax S.A. | Results Abivax to host Satellite Symposium at the 17ᵗʰ Congress of ECCO on Feb. 17, 2022 abivax.com ↗
Remarkably, out of the patients who showed a clinical response at the end of the 8-week induction treatment, 63.5% achieved full clinical remission during this first year of maintenance with once-daily 50mg oral ABX464. |
| 2021-10-18 | Abivax S.A. | Results ABX464 shows excellent long-term efficacy data in Abivax’s phase 2b maintenance trial in ulcerative colitis abivax.com ↗
These data emphasize ABX464’s capacity to maintain and further improve pat ient-outcomes over time, as well as its continued favorable safety and tolerability. |
| 2021-09-14 | Abivax S.A. | Results Abivax provides an update on the ABX464 clinical data and development strategy in ulcerative colitis abivax.com ↗
Excellent once-daily oral ABX464 efficacy and safety data in the phase 2b clinical trial in ulcerative colitis (UC) patients, previously reported at 8-weeks, are further improved at 16-weeks |
| 2021-08-17 | Abivax S.A. | Regulatory Abivax receives approval for ABX464 phase 1 study in Japanese subjects for subsequent inclusion of Japan into the global phase 3 program in ulcerative colitis abivax.com ↗ |
| 2021-05-24 | Abivax S.A. | Results Abivax reports excellent efficacy and safety of ABX464 in phase 2b clinical trial in ulcerative colitis and plans to proceed to phase 3 abivax.com ↗
The top-line data showed significant clinical efficacy in the overall patient population on primary and key secondary endpoints and a good safety profile of ABX464 during 8 weeks of induction treatment. |
| 2021-03-05 | Abivax S.A. | Results Abivax follows DSMB recommendation to stop the phase 2b/3 miR-AGE Covid-19 clinical trial due to lack of efficacy abivax.com ↗
Abivax (Euronext Paris: FR0012333284 – ABVX), a clinical-stage biotechnology company modulating the immune system to develop novel treatments for inflammatory diseases, viral diseases and cancer, announces today that it is halting the miR-AGE phase 2b/3 clinical trial in high-risk Covid-19 patients after the independent Data Safety and Monitoring Board (DSMB) recommendation for lack of efficacy. |
| 2021-03-03 | Abivax S.A. | Results Abivax publishes data of ABX464 induction and long-term maintenance phase 2a ulcerative colitis study in the prestigious journal “Gastroenterology" abivax.com ↗
today announced that the induction and long-term maintenance follow-up results of the phase 2a clinical study with ABX464 for the treatment of moderate-to-severe ulcerative colitis have been published online in the renowned journal “Gastroenterology”. |
| 2020-12-22 | Abivax S.A. | Regulatory Abivax’s Covid-19 phase 2b/3 miR-AGE trial with ABX464 declared Research National Priority by the French government’s clinical trial council abivax.com ↗ |
| 2020-09-02 | Abivax S.A. | Results Abivax reports long-lasting two-year efficacy and safety data from ABX464 ulcerative colitis Phase 2a maintenance study abivax.com ↗
These data confirm good safety and efficacy results of ABX464 during the second year of treatment, which were already observed during the induction and first year of the maintenance study. |
| 2020-06-22 | Abivax S.A. | Regulatory Abivax provides business update on most recent achievements and announces positive results of annual ordinary and extraordinary general meeting abivax.com ↗
The Brazilian Health Regulatory Agency (ANVISA - Agência Nacional de Vigilância Sanitária) approved the randomized, double-blind and placebo-controlled miR-AGE trial in high-risk COVID-19 patients. |
| 2020-05-25 | Abivax S.A. | Regulatory Abivax announces German regulatory approval of ABX464 Covid-19 Phase 2b/3 COVID-19 clinical trial abivax.com ↗
Abivax SA (Euronext Paris: FR0012333284 – ABVX), a late stage clinical biotechnology company harnessing the immune system to develop novel treatments for inflammatory diseases, viral diseases and cancer, announces today that the German regulatory authority for drugs and medical products, BfArM (Bundesinstitut für Arnzeimittel und Medizinprodukte), has approved its Phase 2b/3 study of ABX464 in COVID-19 patients. |
| 2020-05-14 | Abivax S.A. | Results ABX464 inhibits replication of SARS-CoV-2 (COVID-19) in reconstituted human respiratory epithelium model abivax.com ↗
Abivax SA (Euronext Paris: FR0012333284 – ABVX), a clinical-stage biotechnology company harnessing the immune system to develop novel treatments for inflammatory diseases, viral diseases and cancer, announces today that ABX464 inhibits replication of SARS-CoV-2 in an in vitro reconstituted human respiratory epithelium model, as assessed by Transepithelial electrical resistance and RTqPCR. |
| 2020-05-14 | Abivax S.A. | Regulatory Abivax receives ANSM and Ethics Committee clearance to test its development candidate ABX464 in 1,034 Covid-19 patients in randomized Phase 2b/3 clinical trial abivax.com ↗
French regulator, ANSM, as well as Ethics Committee, CPP, have cleared ABX464 for Phase 2b/3 “miR-AGE” testing |
| 2020-01-20 | Abivax S.A. | Regulatory Abivax Receives Clearance from U.S. FDA to Initiate Clinical Trials with ABX464 to treat Moderate to Severe Ulcerative Colitis abivax.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has approved an investigational new drug (IND) application for their lead drug candidate ABX464, allowing the initiation of clinical trials in the U.S. in patients with moderate-to-severe ulcerative colitis (UC). |
| 2019-11-21 | Abivax S.A. | Regulatory Abivax Receives French Regulatory Authority (ANSM) Approval to Include French Study Sites in its Phase 2b Ulcerative Colitis Clinical Trial and Provides a Progress Update of the ABX464 Clinical Development Plan in other Inflammatory Diseases abivax.com ↗
With the French Regulatory Approval by ANSM, the clinical trial is fully approved in 15 countries |
| 2019-10-21 | Abivax S.A. | Results ABIVAX Reports Impressive 12-month Efficacy and Safety Data from ABX464 Ulcerative Colitis Maintenance Study at United European Gastroenterology Conference abivax.com ↗
ABIVAX SA (Paris:ABVX) (Euronext Paris: FR0012333284 – ABVX), a clinical-stage biotechnology company harnessing the immune system to develop novel treatments for inflammatory diseases, viral diseases and cancer, announced today new data showing that 75% of the patients were in clinical remission after a 12-month open-label oral ABX464 Phase 2a maintenance study in subjects with moderate-to-severe active ulcerative colitis (UC) who had failed immunomodulators, anti-TNFα, vedolizumab and/or corticosteroids. |
| 2019-06-04 | Abivax S.A. | Regulatory Abivax Receives First Clinical Trial Authorization for ABX464 Phase 2a Study in Patients with Rheumatoid Arthritis abivax.com ↗
Abivax (Euronext Paris: FR0012333284 – ABVX), a clinical-stage biotechnology company harnessing the immune system to develop novel treatments for inflammatory diseases, viral diseases and cancer, announced today that France is the first country to have fully authorized its phase 2a clinical trial application of ABX464 for treatment of patients with moderate to severe active rheumatoid arthritis (RA). |
| 2019-05-22 | Abivax S.A. | Results Abivax Delivered Oral Presentation at Leading US International Gastroenterology Conference on ABX464 Phase 2a Nine-month Maintenance Data Demonstrating Long Term Efficacy and Safety in Ulcerative Colitis abivax.com ↗
At nine months treatment with ABX464, 18 of 19 patients have sustained clinical responses |
| 2019-04-30 | Abivax S.A. | Regulatory Abivax Receives First Phase 2b Ulcerative Colitis Clinical Trial Authorization, Provides Update on Progress of ABX464 Clinical Development Plan in Inflammatory Diseases abivax.com ↗
Abivax (Paris:ABVX) (Euronext Paris: FR0012333284 – ABVX), a clinical-stage biotechnology company harnessing the immune system to develop treatments for inflammatory and viral diseases as well as cancer, announced today that Canada is the first country to have fully authorized its phase 2b clinical trial design for ABX464 to treat ulcerative colitis (UC). |
| 2019-03-11 | Abivax S.A. | Results Abivax Presents Impressive New Phase 2a ABX464 Ulcerative Colitis 6-Months Maintenance Study Data in Oral Plenary Session at Annual Congress of European Crohn’s and Colitis Organisation (ECCO) abivax.com ↗
The presentation, given by Dr. Jean-Marc Steens, M.D., Chief Medical Officer of Abivax, showed that the magnitude of ABX464’s effects continued to increase during the first six months of the ongoing 12-month open-label, roll-over “maintenance” extension study, ABX464-102. |
| 2019-01-28 | Abivax S.A. | Results Abivax Publishes in Nature Scientific Reports ABX464's Unique Mechanism of Action Leading to Both Anti-Inflammatory and Antiviral Effects abivax.com ↗
The research, entitled “Both anti-inflammatory and antiviral properties of novel drug candidate ABX464 are mediated by modulation of RNA splicing,” concludes that ABX464’s ability to selectively upregulate anti-inflammatory miR-124 and selectively splice viral RNA, but not endogenous cellular RNA, may have applicability for treatment of both inflammatory diseases and HIV infection. |
| 2019-01-23 | Abivax S.A. | Results Abivax Hosts KOL Event in Geneva on Therapeutic Candidate ABX464 for Ulcerative Colitis abivax.com ↗
In the study, ABX464 statistically significantly improved both clinical and endoscopic endpoints in the placebo-controlled European trial in 32 UC patients. |
| 2018-12-20 | Abivax S.A. | Results Abivax’s phase 2a ulcerative colitis clinical trial data selected for oral plenary presentation at 14th Congress of European Crohn’s and Colitis Organisation abivax.com ↗
Favorable safety and statistically significant efficacy of oral ABX464 demonstrated in a completed randomized, double-blind, placebo-controlled induction trial based on clinical and endoscopic endpoints |
| 2018-12-06 | Abivax S.A. | Results Abivax receives DSMB recommendation to continue ongoing extension study of its completed phase 2a clinical trial in ulcerative colitis patients abivax.com ↗
The final data from this 2-month double-blind clinical study indicated that ABX464 was safe, well-tolerated, and demonstrated statistically significant efficacy based on both clinical and endoscopic endpoints in this study. |
| 2018-09-04 | Abivax S.A. | Results Abivax reports impressive results in clinical phase 2a trial of ABX464 as an oral treatment for ulcerative colitis patients abivax.com ↗
In summary, the topline data indicate that ABX464 was safe, well-tolerated, and demonstrated statistically significant efficacy based on both clinical and endoscopic endpoints in this study. |
| 2018-07-26 | Abivax S.A. | Results Abivax Presents ABX464 Mechanism of Action Data at the 22nd International AIDS Conference (AIDS 2018) abivax.com ↗
Binding of ABX464 to Cap Binding Complex (CBC) enhances RNA splicing of viral and non-translated human RNA, mediating antiviral and anti-inflammatory effects |
| 2018-07-03 | Abivax S.A. | Results Abivax releases positive top line data from ABX464-005 phase 2a study in HIV infection abivax.com ↗
today announced positive top line data for the second cohort of the ABX464-005 phase 2a study in HIV infection. |
| 2018-05-31 | Abivax S.A. | Results ABIVAX Presents New Data on ABX464 Mechanism of Action at 16th European Meeting on HIV & Hepatitis abivax.com ↗
These latest results explain why ABX464 could be delivering a dual anti-HIV effect via its antiviral and anti-inflammatory properties. |
| 2018-01-04 | Abivax S.A. | Regulatory ABIVAX to Initiate Long-Term Extension Study of ABX464 in Patients with Ulcerative Colitis abivax.com ↗
today announced that the follow-up protocol ABX464-102 has been authorized by the Regulatory Authority and Ethics Committee in Belgium. |
| 2017-12-15 | Abivax S.A. | Results ABIVAX’s ABX464 Phase IIa Data confirm HIV Reservoir Reduction in Oral Presentation at 8th International Workshop on HIV Persistence During Therapy abivax.com ↗
The results show a statistically significant reduction (p<0.01) of the HIV viral reservoir in the blood of study participants with HIV. |
| 2017-12-07 | Abivax S.A. | Results ABIVAX to present in plenary session at the 8th international conference on HIV persistence during therapy abivax.com ↗
These data confirm ABX464’s ability to reduce viral DNA and show that it is safe in patients. |
| 2017-09-28 | Abivax S.A. | Results ABIVAX’s ABX464 Reduces HIV Reservoir in Blood in Second Phase 2a Clinical Trial abivax.com ↗
ABIVAX (Euronext Paris: FR0012333284 – ABVX), an innovative biotechnology company targeting the immune system to eliminate viral diseases using its unique technology platform, today announced top-line results from the first cohort of its Phase 2a trial, ABX464-005, demonstrating that ABX464 significantly reduced the HIV viral reservoir in blood in patients with HIV. |
| 2017-09-20 | Abivax S.A. | Regulatory ABIVAX receives French regulatory Approval to Begin Clinical Trial of ABX464 in Ulcerative Colitis abivax.com ↗ |
| 2017-07-13 | Abivax S.A. | Results ABIVAX to present latest clinical data on ABX464 at the International Aids Society Conference in Paris, France abivax.com ↗
ABX464 impacted the HIV blood reservoir in this Phase IIa clinical trial, supporting its potential to become a key functional cure component for HIV. |
| 2017-07-12 | Abivax S.A. | Results New Experimental Data on Anti-inflammatory Effects of ABX464, ABIVAX’s First-in-Class Drug Candidate to Achieve Functional Cure in HIV-Patients, Published in Nature Scientific Reports abivax.com ↗
ABX464 was shown to stimulate the expression of the anti-inflammatory cytokine IL-22 in macrophages in preclinical testing. |
| 2017-05-02 | Abivax S.A. | Results First ever evidence of treatment-induced reduction in HIV reservoirs abivax.com ↗
ABIVAX announced today that the company’s lead therapeutic candidate ABX464 demonstrated the first reduction in HIV reservoirs ever observed in chronically infected HIV patients as measured by total HIV DNA detected in peripheral blood mononuclear cells (PBMCs). |
| 2017-02-02 | Abivax S.A. | Results Phase I Clinical Data of ABX464, ABIVAX’s First-in-Class anti-HIV Drug, Published in Two Articles in Peer-Reviewed Journals abivax.com ↗
ABIVAX (Euronext Paris: FR0012333284 – ABVX), an innovative biotechnology company targeting the immune system to eliminate viral diseases, announced today that the previously disclosed results of its two Phase I trials with ABX464 in healthy volunteers have now been published in peer-reviewed journals: Journal of Antimicrobial Chemotherapy and, separately, Antimicrobial Agents and Chemotherapy. |
| 2016-12-08 | Abivax S.A. | Results ABIVAX Reports New Preclinical Data Supporting ABX464 as HIV Functional Cure and Novel Treatment for Inflammatory Diseases at HIV DART Meeting abivax.com ↗
The data show that in in vitro models, ABX464 exposure leads to a 50-fold upregulation of IL-22, a potent anti-inflammatory cytokine, by macrophages as well as a 10-fold upregulation of the anti-inflammatory microRNA miR-124 in T-lymphocytes. |
| 2016-12-06 | Abivax S.A. | Regulatory ABIVAX provides update on clinical development program for ABX464 for functional cure of patients with HIV-infection abivax.com ↗
On top of the ongoing ABX464-004 Phase IIa study, ABIVAX recently requested regulatory and ethics committee approval for a new study, which is a compartmental pharmacokinetics (PK) clinical study (ABX464-005). |
| 2016-10-27 | Abivax S.A. | Results ABIVAX presented this week new pre-clinical data on ABX464 during scientific conference on “HIV Drug Therapy” in Glasgow, Scotland abivax.com ↗
Results indicate that reservoir cells may be key target for ABX464’s primary metabolite |
| 2016-04-19 | Abivax S.A. | Regulatory ABIVAX obtains regulatory and ethics clearance in Spain to begin second Phase IIa clinical trial for ABX464 in HIV/AIDS patients abivax.com ↗ |
| 2016-02-25 | Abivax S.A. | Results ABIVAX’s Novel Approach to Treat HIV Demonstrates Safety and Preliminary Anti-viral Activity in Phase IIa abivax.com ↗
Paris, France, February 25th, 2016 – ABIVAX (Euronext Paris: FR0012333284 – ABVX), an emerging leader in developing and commercializing anti-viral drugs and therapeutic vaccines for diseases like HIV/AIDS and chronic hepatitis B (CHB), today presented data from the Company’s Phase IIa study demonstrating the safety and potent viral reduction capacity of ABX464 in treatment-naïve HIV positive patients. |
| 2016-01-11 | Abivax S.A. | Results ABIVAX announces positive top-line clinical Phase IIa data for novel HIV drug-candidate ABX464 abivax.com ↗
ABIVAX (Euronext Paris: FR0012333284 – ABVX), an emerging leader in developing and commercializing novel antiviral therapies for diseases like HIV/AIDS and chronic Hepatitis B (CHB), today announced positive top-line efficacy and safety results from the Company’s Phase IIa clinical study (ABX464-003) in patients with HIV infection. |
| 2015-11-30 | Abivax S.A. | Results ABIVAX reports healthy volunteers Phase I data for ABX464 abivax.com ↗
ABIVAX (Euronext Paris: FR0012333284 – ABVX), an emerging leader in developing and commercializing anti-viral drugs and therapeutic vaccines for diseases like HIV/AIDS and chronic hepatitis B (CHB), today announced positive results of first clinical evaluation of ABX464 in healthy volunteers for safety and pharmacokinetics. |
| 2015-04-13 | Abivax S.A. | Results Mechanism of action of ABIVAX’s First-in-class anti-HIV drug published today in peer-reviewed journal Retrovirology abivax.com ↗
ABX464 blocks viral replication by preventing the export of viral RNA from the nucleus to the cytoplasm in infected cells. |
All press releases naming this drug 111 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 111 releases opens the full record — a long page | ||
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 26 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | obefazimod | “a first-in-class drug candidate ABX464 (obefazimod, 50 mg and 100 mg per day)” PMID 35641124 ↗ Jul 2022 |
| Known as | ABX464 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03368118 ↗ |
| Known as | SPL-464 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297344 ↗ |
| Action | Inhibit | “ABX464 is a novel antiviral that inhibits HIV RNA biogenesis.” PMID 34436569 ↗ Jun 2022 |
| Modality | Small molecule | “ABX464 (obefazimod) is a small molecule” PMID 36075249 ↗ Sep 2022 |
| Route | Oral | “The primary objective of the study was to assess the safety and tolerability of ABX464 after repeated oral administrations in subjects infected by HIV.” PMID 28507108 ↗ Jun 2017 |