Abivax Announces Promising One-Year Phase 2a Maintenance Results of ABX464 in Rheumatoid Arthritis

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  • Of the 40 patients included in the ABX464 maintenance study, 23 patients have now reached the first year of treatment and all have achieved at least an ACR20 [1] with 19 and 12 patients achieving ACR50 and ACR70 respectively
  • Long-term safety profile (50mg ABX464 once daily + MTX) favorable and consistent with previous observations
  • Induction and maintenance results support clinical development of ABX464 in RA and potentially other rheumatology indications
  • Clinical induction and maintenance data in ulcerative colitis and rheumatoid arthritis underpin the potential of ABX464 to treat a wide range of chronic inflammatory diseases
  • In G7 countries, the ulcerative colitis, Crohn’s disease and rheumatoid arthritis market is expected to reach around USD 50 billion in 2026

PARIS, FRANCE / ACCESSWIRE / March 10, 2022 / Abivax SA (Euronext Paris: FR0012333284 – ABVX), a clinical-stage biotechnology company developing novel immune-modulating therapies to treat chronic inflammatory diseases, viral infections and cancer, today announces promising results from its maintenance trial of phase 2a in rheumatoid arthritis (RA) after one year of continuous daily treatment with 50 mg of ABX464.

Professor Paul Emery, MD, FMedSci, Versus Arthritis Professor of Rheumatology, Director of Leeds Musculoskeletal Biomedical Research Centre, Leeds Teaching Hospitals Trust, Leeds Institute of Rheumatic and Musculoskeletal Medicine, UK, commented: “The high levels of response rates maintained in this Phase 2a maintenance trial with ABX464 in patients with rheumatoid arthritis, particularly with respect to ACR50 and ACR70 responses, look very promising. The molecule also demonstrated a good safety profile and no serious infections were observed. With its very different mode of action and clinical profile, ABX464 has the potential to play an important role in the future management of patients with rheumatoid arthritis.

Professor William Robinson, MD, Ph.D., Head of Division of Immunology and Rheumatology, Stanford University, USA, added: “Patients suffering from chronic inflammatory diseases, such as RA, often struggle to find a suitable treatment that remains effective over time. These maintenance data are very encouraging and demonstrate potential long-term efficacy and safety of ABX464 for the treatment of RA, even in patients who have failed or ceased to respond to available therapies.”

Professor Hartmut J. Ehrlich, MD, CEO of Abivax, said: “These results clearly support the continued clinical development of ABX464 for the treatment of rheumatoid arthritis. Additionally, they are consistent with data generated in our phase 2a and 2b trials in ulcerative colitis and suggest that ABX464 has the ability to treat a wide range of chronic inflammatory diseases. indications, a pathological field with a high and persistent medical need and with millions of patients waiting for new safe drugs with long-lasting efficacy. »

After the 12-week randomized, placebo-controlled Phase 2a induction study in 60 RA patients, 67% of patients (40/60) entered the open-label extension study to receive 50 mg of ‘ABX464 orally once a day for an additional period. 52 weeks.

58% of patients (23/40) with moderate to severe active RA completed 52 weeks of chronic treatment with ABX464. The efficacy of ABX464 50 mg once daily was assessed by DAS28-CRP remission (DAS28-CRP [2] ) and ACR20/50/70 rates:

At week 52*

Complete analysis package

(n=40)
(imputation of non-respondents)

Observed cases

(n=23)

Delivery

According to DAS28-CRP

13 (33%)

13 (57%)

Low disease activity

According to DAS28-CRP

17 (43%)

17 (74%)

ACR20

23 (58%)

23 (100%)

ACR50

19 (48%)

19 (83%)

ACR70

12 (30%)

12 (52%)

*Results based on a review of the software lock database

57% of patients (13/23) were in remission at week 52, assessed by DAS28-CRP (

The 23 patients (100%) who completed 52 weeks of treatment achieved at least an ACR20 response, which translates to 58% (23/40) in FAS.

It is remarkable that according to the observed case population, 83% (19/23) and 52% (12/23) even achieved an ACR50 and ACR70 response respectively, corresponding to 48% (19/40) and 30% (12 /40) according to the FAS.

17 patients discontinued the study during the first year of maintenance treatment due to mild to moderate adverse events or worsening of RA.

ABX464 was safe and the nature of adverse events is consistent with what has been observed in over 1,000 subjects who have so far been treated in other clinical trials with ABX464 in different indications. Currently, some UC patients have been treated continuously for four years.

ABX464 Phase 2a Induction and Maintenance Studies in Rheumatoid Arthritis
The Phase 2a placebo-controlled clinical study was designed to evaluate the safety, tolerability and preliminary efficacy of two oral doses of ABX464 administered once daily (50 mg or 100 mg), in combination with the methotrexate (MTX). 60 patients who had an inadequate response to MTX and/or to one or more anti-tumor necrosis factor alpha (TNFα) biological therapies took part in this randomized double-blind trial. The study was conducted in 21 study centers in four European countries (France, Belgium, Poland and Hungary).

After the end of the 12-week induction study, 40 patients continued treatment in the maintenance study with an oral once-daily dose of 50 mg of ABX464.

In June 2021, Abivax reported results from the induction phase of its Phase 2a clinical study of ABX464 administered in combination with methotrexate (MTX) for the treatment of moderate to severe active RA. The primary endpoint of this study, safety and tolerability, was achieved with 50 mg of ABX464 once daily, demonstrating a good safety and tolerability profile in the overall patient population during the 12-week induction phase.

Epidemiology and Market Size of Rheumatoid Arthritis
In 2021, there were approximately 3.8 million diagnosed cases of rheumatoid arthritis in G7 countries (US, France, Germany, Italy, Spain, UK and Japan). The total size of the rheumatoid arthritis market is currently $22.3 billion per year, based on estimated 2021 rheumatoid arthritis pharmaceutical sales in these countries.

The currently accessible market for ABX464 in IBD (ulcerative colitis and Crohn’s disease) and rheumatoid arthritis is expected to reach $50 billion by 2026. [3]

***

About Abivax (www.abivax.com)
Abivax, a clinical-stage biotechnology company, develops novel therapies that modulate physiological inflammation and immunological pathways to treat patients with chronic inflammatory diseases, viral infections and cancer. Abivax is listed on Euronext compartment B (ISIN: FR0012333284 – Ticker: ABVX). Based in Paris and Montpellier, Abivax has two drug candidates in clinical development, ABX464 for the treatment of severe chronic inflammatory diseases and ABX196 for the treatment of hepatocellular carcinoma. More information about the company is available at www.abivax.com. Follow us on Twitter @ABIVAX_.

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This press release contains forward-looking statements, forecasts and estimates (including patient recruitment) regarding some of the Company’s programs. Although the Company believes that its forward-looking statements, forecasts and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors that have been deemed reasonable, such forward-looking statements, forecasts and estimates are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated in such forward-looking statements, forecasts and estimates. A description of these risks, contingencies and uncertainties appears in the documents filed by the Company with the Autorité des Marchés Financiers pursuant to its legal obligations, in particular its Universal Registration Document. Particular attention should be given to potential difficulties in clinical and pharmaceutical development, including further evaluation by society, regulatory agencies and ethics committees of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC, clinics. Further, these forward-looking statements, forecasts and estimates speak only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update any such forward-looking statements, forecasts or estimates to reflect any subsequent changes of which the Company becomes aware, except as required by law.

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[1] The ACR score from the American College of Rheumatology measures the effectiveness of treatments for patients with rheumatoid arthritis. The ACR20/50/70 measures a 20/50/70% improvement in tenderness and swelling in the designated joints and a 20/50/70% improvement in at least 3 of the following 5 measures: assessment Investigator and Patient Reported Disease Global Scales, Patient Reported Pain Scale, CRP Level, Health Assessment Questionnaire.

[2] DAS28-CRP-Disease Activity Score for 28 joints – C-reactive protein

[3] Source: Informa

THE SOURCE: ABIVAX

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