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    ABVX   FR0012333284

ABIVAX

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PRESS RELEASE : Abivax reports excellent phase 2a clinical safety and efficacy results with 50mg ABX464 in rheumatoid arthritis

06/23/2021 | 02:02am EDT
DGAP-News: ABIVAX / Key word(s): Study/Study results 
Abivax reports excellent phase 2a clinical safety and efficacy results with 50mg ABX464 in rheumatoid arthritis 
2021-06-23 / 08:00 
The issuer is solely responsible for the content of this announcement. 
=---------------------------------------------------------------------------------------------------------------------- 
Abivax reports excellent phase 2a clinical safety and efficacy results with 50mg ABX464 in rheumatoid arthritis 
  . Primary endpoint met with ABX464 demonstrating good safety and tolerability profile with 50mg once daily oral 
    administration 
  . A statistically significant difference (p < 0.03) was met on key efficacy endpoint ACR20^[1] in the PP^[2] 
    population with 60% of ABX464 patients dosed with 50mg reaching that endpoint versus 22% in the placebo group 
  . Other key efficacy endpoints (ACR50, ACR70, DAS28-CRP^[3], CDAI^[4]) as well as biological markers (CRP, miR-124, 
    IL-6) showed favorable differences with 50mg ABX464 over placebo 
  . Abivax is preparing to start a clinical phase 2b program in rheumatoid arthritis in early 2022 
  . Given the demonstrated safety and efficacy of ABX464 in rheumatoid arthritis and ulcerative colitis, Abivax is 
    exploring additional programs in chronic inflammatory indications 
  . Abivax to host webcast on Wednesday June 23, 2021 at 2:00 pm CEST (8:00 am EST) 
PARIS, France, June 23, 2021 - 8:00 am (CEST) - 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, announces excellent top-line results of the induction phase of its phase 2a 
clinical study of ABX464 administered in combination with methotrexate (MTX) for the treatment of active moderate to 
severe rheumatoid arthritis (RA). 60 patients who had either an inadequate response to methotrexate and/or TNF? 
inhibitors participated in the study. 
The primary endpoint of this study, safety and tolerability, was met with 50mg ABX464 once daily demonstrating a good 
safety and tolerability profile in the overall patient population during the 12-week induction phase. 
Although the sample size of this study was not powered to show efficacy, the 50mg group already showed statistically 
significant differences for the key secondary endpoint ACR20 compared to placebo at week 12 in the Per Protocol 
population. The ACR20 is the key primary efficacy endpoint required by the FDA for licensure of new drugs in rheumatoid 
arthritis. 
Based on these results, Abivax is preparing to start a clinical phase 2b program in RA in early 2022.^[5] 
ABX464 is a small molecule for once-daily administration with a first-in-class mechanism of action, centered around the 
upregulation of the anti-inflammatory microRNA, miR-124. ABX464 was already shown to be efficacious and safe in phase 
2a and phase 2b clinical studies for the treatment of ulcerative colitis (UC). 
Prof. Claire Daien, M.D., Ph.D., rheumatologist at the University Hospital at Montpellier and principal investigator of 
the study, said: "I am excited about these positive clinical phase 2a results. 50mg once daily oral treatment with 
ABX464 shows to be well tolerated and efficacious in patients in the induction study. This is remarkable, as these 
top-line efficacy results are at par with currently available treatments. Even if the standard of care made some 
progress during the past years, too many patients still do not respond or lose responsiveness to available drugs, and 
new molecules with a different mechanism of action, like ABX464, are needed. Therefore, ABX464 should move to phase 2b 
testing as quickly as possible." 
Prof. Hartmut J. Ehrlich, M.D., CEO of Abivax, added: "ABX464 has already shown good safety and robust, sustained 
efficacy in our phase 2a and phase 2b induction and maintenance clinical trials for the treatment of ulcerative 
colitis. Combined with the phase 2a results in RA, we believe that ABX464 may have an important potential as a novel, 
highly differentiated anti-inflammatory therapeutic agent across various inflammatory indications. Just as ulcerative 
colitis and Crohn's disease, rheumatoid arthritis is an irreversible, debilitating, and systemic autoimmune disease 
that often requires aggressive treatment to control it. This disease represents a major burden for the millions of 
affected patients, their families and for healthcare systems worldwide and there is an urgent need for new efficacious 
and well tolerated therapeutic management options." 
50mg once daily oral administration of ABX464 is safe and well tolerated by RA patients with previous inadequate 
response to MTX and/or to one or more anti-tumor necrosis factor alpha (TNF?) biological therapeutics and shows very 
promising efficacy results 
The clinical phase 2a study was designed to evaluate the safety, tolerability and preliminary efficacy of two oral 
dose-levels of ABX464 administered once daily (50mg and 100mg), in combination with methotrexate (MTX). 60 patients who 
had an inadequate response to MTX and/or to one or more anti-tumor necrosis factor alpha (TNF?) biological therapeutics 
participated in this randomized, double-blind, placebo-controlled trial. Patients received ABX464 (50mg or 100mg) or 
placebo during the 12-week induction treatment phase. The study was conducted in 21 study centers across four European 
countries (France, Belgium, Poland and Hungary). The treatment groups were well balanced in terms of disease severity 
as well as patient demographics. 
The primary endpoint of the study was met with 50mg ABX464 once daily being safe and well tolerated during the 12-week 
induction phase. No deaths or malignancies were reported in the study. One serious adverse event (SAEs) was reported in 
the placebo group and one in the 100mg dose group, while no SAE was reported in the 50mg dose group. 3 patients in the 
50mg group, 12 patients in the 100mg group and 1 patient in the placebo group prematurely discontinued the study. An 
increased incidence of largely mild to moderate gastrointestinal adverse events in the 100mg treatment group is likely 
due to an overlapping side effect profile with methotrexate (MTX), leading to a higher drop-out rate of patients, 
especially as it refers to nausea and emesis. Therefore, the 100mg dose will not be considered for future clinical 
development of ABX464 in rheumatoid arthritis. 
The nature of these adverse events is consistent with what has been observed in more than 800 subjects who have so far 
been treated in other clinical trials with ABX464 across different indications. 
Secondary efficacy endpoints included the proportion of patients achieving ACR20/50/70 responses, change from baseline 
in DAS28-CRP low disease activity (DAS28-CRP <= 3.2) and Clinical Disease Activity Index (CDAI). 
                               Placebo          50 mg           100 mg 
                            PP^+     ITT     PP^+     ITT    PP^+     ITT 
                           (n=18)  (n=20)   (n=15)  (n=21)   (n=7)  (n=19) 
Early discontinuations            1               3               12 
Mean DAS28-CRP at Baseline       5.3             5.5              5.5 
ACR20                      4 (22%) 4 (20%) 9 (60%)* 9 (43%) 3 (43%) 3 (16%) 
ACR50                      1 (6%)  1 (5%)  5 (34%)  5 (24%) 2 (29%) 2 (11%) 
ACR70                      1 (6%)  1 (5%)  4 (27%)  4 (19%) 1 (14%) 1 (5%) 
DAS28-CRP                   -0.63   -0.63   -1.78    -1.74   -1.95   -1.95 
change from baseline 
Low Disease Activity       2 (11%) 2 (10%) 4 (25%)  4 (19%) 3 (43%) 3 (16%) 
(DAS28-CRP <= 3.2) 
CDAI <= 10                 2 (11%) 2 (10%) 5 (31%)  5 (24%) 3 (43%) 3 (16%) 

* P < 0.03 - Statistical tests were only conducted for ACR20 as part of topline results ^+ PP Per Protocol population set for ACR levels

In addition, a DAS28-CRP remission (DAS-CRP < 2.6) has been reported in 19% of patients dosed with 50mg ABX464 compared to 5% in the placebo group (ITT). Regarding biomarkers, a significant upregulation of miR-124 expression was observed for every patient dosed with ABX464, and a decrease in IL-6 blood levels was observed in both active dose groups compared to placebo.

Patients who completed the induction study could roll over into a two-year open-label maintenance study to evaluate the long-term safety and efficacy of 50mg once daily oral ABX464 in RA. One-year data from this study will become available in Q1 2022.

Epidemiology, unmet medical needs and market size in rheumatoid arthritis

In 2020, there were an estimated 3.8M diagnosed cases of rheumatoid arthritis in G7 countries (US, France, Germany, Italy, Spain, UK and Japan). Despite the existing therapeutic options for RA including biologic disease-modifying antirheumatic drugs 74% of patients report dissatisfaction with their treatment plans mandates more patients-centered therapeutic options which are safe and easy to administer.^[6] The total market size in RA is USD 20.4B annually, based on 2020 pharmaceutical sales estimates for rheumatoid arthritis in these countries, estimated to grow to USD 22.9B by 2025. The currently accessible market for ABX464 in IBD and RA is estimated to grow to USD 48B by 2025, while the overall chronic inflammation market is estimated to exceed USD 110B at that time.^[7]

ABX464 phase 3 in UC, phase 2b in Crohn's disease and phase 2b clinical trial in rheumatoid arthritis (RA)

A pivotal phase 3 clinical trial program in UC is expected to be initiated by the end of 2021.

A dose ranging, randomized, placebo-controlled pivotal phase 2b trial in Crohn's disease patients is expected to be initiated before the end of the year.

A phase 2b dose ranging study in RA is expected to start in early 2022.

Based on the encouraging data in UC and RA, Abivax is planning to explore additional chronic inflammatory indications in the near future. About ABX464^[8]^[9]

(MORE TO FOLLOW) Dow Jones Newswires

June 23, 2021 02:01 ET (06:01 GMT)

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Sales 2021 99,4 M 118 M 118 M
Net income 2021 8,60 M 10,2 M 10,2 M
Net cash 2021 50,3 M 59,7 M 59,7 M
P/E ratio 2021 37,6x
Yield 2021 -
Capitalization 488 M 580 M 580 M
EV / Sales 2021 4,40x
EV / Sales 2022 640x
Nbr of Employees 27
Free-Float 71,6%
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Hartmut J. Ehrlich Chief Executive Officer
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Philippe Pouletty Chairman
Didier Scherrer Vice President-Research & Development
Paul Gineste Vice President-Clinical Operations
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