Major endpoint met with ABX464 demonstrating good security and tolerability profile with 50mg as soon as day by day oral administrationA statistically important distinction (p < 0.03) was met on key efficacy endpoint ACR20  within the PP  inhabitants with 60% of ABX464 sufferers dosed with 50mg reaching that endpoint versus 22% within the placebo groupDifferent key efficacy endpoints (ACR50, ACR70, DAS28-CRP  , CDAI  ) in addition to organic markers (CRP, miR-124, IL-6) confirmed favorable variations with 50mg ABX464 over placeboAbivax is making ready to start out a medical section 2b program in rheumatoid arthritis in early 2022Given the demonstrated security and efficacy of ABX464 in rheumatoid arthritis and ulcerative colitis, Abivax is exploring extra applications in power inflammatory indicationsAbivax to host webcast on Wednesday June 23, 2021 at 2:00 pm CEST (8:00 am EST)
PARIS, FRANCE / ACCESSWIRE / June 23, 2021 / Abivax SA (Euronext Paris: FR0012333284 – ABVX), a clinical-stage biotechnology firm growing novel therapies that modulate the immune system to deal with power inflammatory ailments, viral infections, and most cancers, broadcasts glorious top-line outcomes of the induction section of its section 2a medical examine of ABX464 administered together with methotrexate (MTX) for the therapy of lively average to extreme rheumatoid arthritis (RA). 60 sufferers who had both an insufficient response to methotrexate and/or TNFα inhibitors participated within the examine.
The first endpoint of this examine, security and tolerability, was met with 50mg ABX464 as soon as day by day demonstrating a very good security and tolerability profile within the general affected person inhabitants throughout the 12-week induction section.
Though the pattern dimension of this examine was not powered to indicate efficacy, the 50mg group already confirmed statistically important variations for the important thing secondary endpoint ACR20 in comparison with placebo at week 12 within the Per Protocol inhabitants. The ACR20 is the important thing major efficacy endpoint required by the FDA for licensure of recent medication in rheumatoid arthritis.
Based mostly on these outcomes, Abivax is making ready to start out a medical section 2b program in RA in early 2022. 
ABX464 is a small molecule for once-daily administration with a first-in-class mechanism of motion, centered across the upregulation of the anti-inflammatory microRNA, miR-124. ABX464 was already proven to be efficacious and secure in section 2a and section 2b medical research for the therapy of ulcerative colitis (UC).
Prof. Claire Daien, M.D., Ph.D., rheumatologist on the College Hospital at Montpellier and principal investigator of the examine, mentioned: “I’m enthusiastic about these constructive medical section 2a outcomes. 50mg as soon as day by day oral therapy with ABX464 reveals to be nicely tolerated and efficacious in sufferers within the induction examine. That is exceptional, as these top-line efficacy outcomes are at par with at present accessible remedies. Even when the usual of care made some progress throughout the previous years, too many sufferers nonetheless don’t reply or lose responsiveness to accessible medication, and new molecules with a unique mechanism of motion, like ABX464, are wanted. Due to this fact, ABX464 ought to transfer to section 2b testing as shortly as doable.”
Prof. Hartmut J. Ehrlich, M.D., CEO of Abivax, added: “ABX464 has already proven good security and sturdy, sustained efficacy in our section 2a and section 2b induction and upkeep medical trials for the therapy of ulcerative colitis. Mixed with the section 2a leads to RA, we imagine that ABX464 could have an essential potential as a novel, extremely differentiated anti-inflammatory therapeutic agent throughout numerous inflammatory indications. Simply as ulcerative colitis and Crohn’s illness, rheumatoid arthritis is an irreversible, debilitating, and systemic autoimmune illness that always requires aggressive therapy to regulate it. This illness represents a significant burden for the thousands and thousands of affected sufferers, their households and for healthcare techniques worldwide and there may be an pressing want for brand spanking new efficacious and nicely tolerated therapeutic administration choices.”
50mg as soon as day by day oral administration of ABX464 is secure and nicely tolerated by RA sufferers with earlier insufficient response to MTX and/or to a number of anti-tumor necrosis issue alpha (TNFα) organic therapeutics and reveals very promising efficacy outcomes
The medical section 2a examine was designed to judge the protection, tolerability and preliminary efficacy of two oral dose-levels of ABX464 administered as soon as day by day (50mg and 100mg), together with methotrexate (MTX). 60 sufferers who had an insufficient response to MTX and/or to a number of anti-tumor necrosis issue alpha (TNFα) organic therapeutics participated on this randomized, double-blind, placebo-controlled trial. Sufferers acquired ABX464 (50mg or 100mg) or placebo throughout the 12-week induction therapy section. The examine was performed in 21 examine facilities throughout 4 European international locations (France, Belgium, Poland and Hungary). The therapy teams have been nicely balanced by way of illness severity in addition to affected person demographics.
The first endpoint of the examine was met with 50mg ABX464 as soon as day by day being secure and nicely tolerated throughout the 12-week induction section. No deaths or malignancies have been reported within the examine. One critical adversarial occasion (SAEs) was reported within the placebo group and one within the 100mg dose group, whereas no SAE was reported within the 50mg dose group. 3 sufferers within the 50mg group, 12 sufferers within the 100mg group and 1 affected person within the placebo group prematurely discontinued the examine. An elevated incidence of largely gentle to average gastrointestinal adversarial occasions within the 100mg therapy group is probably going on account of an overlapping aspect impact profile with methotrexate (MTX), resulting in a better drop-out fee of sufferers, particularly because it refers to nausea and emesis. Due to this fact, the 100mg dose is not going to be thought-about for future medical improvement of ABX464 in rheumatoid arthritis.
The character of those adversarial occasions is in step with what has been noticed in additional than 800 topics who’ve to date been handled in different medical trials with ABX464 throughout totally different indications.
Secondary efficacy endpoints included the proportion of sufferers reaching ACR20/50/70 responses, change from baseline in DAS28-CRP low illness exercise (DAS28-CRP <= 3.2) and Scientific Illness Exercise Index (CDAI).
Imply DAS28-CRP at Baseline
change from baseline
Low Illness Exercise
(DAS28-CRP <= 3.2)
CDAI <= 10
* P < 0.03 – Statistical exams have been solely performed for ACR20 as a part of topline outcomes
+ PP Per Protocol inhabitants set for ACR ranges
As well as, a DAS28-CRP remission (DAS-CRP < 2.6) has been reported in 19% of sufferers dosed with 50mg ABX464 in comparison with 5% within the placebo group (ITT). Concerning biomarkers, a big upregulation of miR-124 expression was noticed for each affected person dosed with ABX464, and a lower in IL-6 blood ranges was noticed in each lively dose teams in comparison with placebo.
Sufferers who accomplished the induction examine might roll over right into a two-year open-label upkeep examine to judge the long-term security and efficacy of 50mg as soon as day by day oral ABX464 in RA. One-year information from this examine will turn out to be accessible in Q1 2022.
Epidemiology, unmet medical wants and market dimension in rheumatoid arthritis
In 2020, there have been an estimated 3.8M identified circumstances of rheumatoid arthritis in G7 international locations (US, France, Germany, Italy, Spain, UK and Japan). Regardless of the prevailing therapeutic choices for RA together with biologic disease-modifying antirheumatic medication 74% of sufferers report dissatisfaction with their therapy plans mandates extra patients-centered therapeutic choices that are secure and straightforward to manage.  The overall market dimension in RA is USD 20.4B yearly, primarily based on 2020 pharmaceutical gross sales estimates for rheumatoid arthritis in these international locations, estimated to develop to USD 22.9B by 2025. The at present accessible marketplace for ABX464 in IBD and RA is estimated to develop to USD 48B by 2025, whereas the general power irritation market is estimated to exceed USD 110B at the moment. 
ABX464 section 3 in UC, section 2b in Crohn’s illness and section 2b medical trial in rheumatoid arthritis (RA)
A pivotal section 3 medical trial program in UC is anticipated to be initiated by the top of 2021.
A dose ranging, randomized, placebo-controlled pivotal section 2b trial in Crohn’s illness sufferers is anticipated to be initiated earlier than the top of the 12 months.
A section 2b dose ranging examine in RA is anticipated to start out in early 2022.
Based mostly on the encouraging information in UC and RA, Abivax is planning to discover extra power inflammatory indications within the close to future.
About ABX464  
ABX464 is a extremely differentiated oral drug candidate, with a novel mechanism of motion primarily based on the upregulation of a single microRNA (miR-124) with potent anti-inflammatory properties. ABX464 was proven to exert its anti-inflammatory results by binding to the cap binding complicated (CBC), which sits on the 5′ finish of each RNA molecule within the cell. By binding to the CBC, ABX464 reinforces the organic capabilities of CBC in mobile RNA biogenesis. Particularly, ABX464 enhances the selective splicing of a single lengthy non-coding RNA to generate the anti-inflammatory microRNA, miR-124, which downregulates pro-inflammatory cytokines and chemokines like TNF-α, IL-6, MCP-1 and IL-17, in addition to Th17+ cells thereby “placing a brake” on irritation and suggesting broad potential as a novel anti-inflammatory therapeutic agent. A seven- to ten-fold enhance in miRNA-124 ranges was noticed in colorectal biopsies of UC sufferers handled with ABX464. ABX464 doesn’t impression the splicing of mobile genes. Ulcerative colitis section 2b top-line outcomes in addition to section 2a induction and upkeep information after one and two years of therapy have been beforehand reported.
Investor webcast on section 2a examine outcomes
Abivax will host a webcast on Wednesday, June 23, 2021 at 2:00 pm CEST (8:00 am EST) , to current the top-line information of its ABX464 section 2a medical examine in RA. Following the formal presentation, Abivax senior administration, might be accessible to reply questions.
To take part within the webcast, please observe the weblink: http://media.rampard.com/20210623
About Abivax (www.abivax.com)
Abivax, a medical stage biotechnology firm, is growing novel therapies that modulate the physiological irritation and immunological pathways to deal with sufferers with power inflammatory ailments, viral infections, and most cancers. Abivax is listed on Euronext compartment B (ISIN: FR0012333284 – Mnémo: ABVX). Based mostly in Paris and Montpellier, Abivax has two drug candidates in medical improvement, ABX464 to deal with extreme inflammatory ailments, and ABX196 to deal with hepatocellular carcinoma. Extra info on the corporate is offered at www.abivax.com . Observe us on Twitter @ABIVAX_.
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 The American School of Rheumatology ACR rating measures the efficacy of remedies for rheumatoid arthritis sufferers. The ACR20/50/70 measures a 20/50/70% enchancment within the tenderness and swelling in designated joints and a 20/50/70% enchancment in at the least 3 of the 5 following measures: investigator’s and affected person’s reported international evaluation of illness scales, affected person’s reported ache scale, CRP degree, wholesome evaluation questionnaire.
 PP: Per protocol information
 DAS28-CRP-Illness Exercise Rating for 28 joints – C reactive Protein
 The Scientific Illness Exercise Index (CDAI) is a composite index primarily based on the tenderness and swelling in designated 28 joints and on investigator’s and affected person’s reported international evaluation of illness scales.
 Future medical improvement together with section 2b design and initiation is topic to evaluation of the general preclinical, CMC, toxicology, medical efficacy and security information of ABX464 by EMA, FDA and different regulatory authorities. These top-line outcomes haven’t but been reviewed by regulatory authorities.
 Radawski C, Genovese MC, Hauber B, et al. Affected person perceptions of unmet medical want In rheumatoid arthritis: a cross-sectional survey within the USA. Rheumatol Ther. 2019;6:461-471.
 Supply: Informa
 J. Tazi et al.: Particular and selective induction of miR-124 in immune cells by the quinoline ABX464: a transformative remedy for inflammatory ailments, Drug Discovery Right now, Quantity 26, Concern 4, April 2021, Pages 1030-1039
 S. Vermeire et al.: Induction and long-term follow-up with ABX464 for moderate-to-severe ulcerative colitis: Outcomes of section 2a trial, Gastroenterology, March 2021
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