Abivax publishes new data on the anti-inflammatory mechanism of action of obefazimod

  • The scientific article in the journal Clinical and Translational Gastroenterology describes the ability of obefazimod to selectively up-regulate a single microRNA, miR-124, leading to decreases in proinflammatory cytokines and thereby acting as a “physiological brake” of inflammation and to influence the immune system in vitro, in mouse models of inflammatory bowel disease (IBD), as well as in patients with ulcerative colitis (UC)
  • Obefazimod is a small molecule administered orally once daily that is currently in a Phase 3 clinical trial for the treatment of ulcerative colitis (ABTECT program)

PARIS, FRANCE / ACCESSWIRE / January 5, 2023 / Abivax SA (Euronext Paris: FR0012333284: – BVX), a Phase 3 clinical biotechnology company focused on developing therapies that modulate the immune system for the treatment of patients with chronic inflammatory diseases, today announced the publication of a paper scientific review in the peer-reviewed journal Clinical and Translational Gastroenterology (CTG) titled: “ABX464 (obefazimod) up-regulates miR-124 to reduce pro-inflammatory markers in inflammatory bowel disease.” [1]

The publication highlights obefazimod’s novel mechanism of action (MoA) and its ability to treat patients with moderate to severe UC. The article extends observations reported in previous Abivax publications of Phase 2a and Phase 2b clinical trials in ulcerative colitis to include patients who have not responded or have stopped responding to currently available therapies.

The article reports that obefazimod has been observed to impact the immune system in vitro , in mouse models of IBD, as well as in patients with UC. The up-regulation of a single microRNA, miR-124, in vitro shows that the MoA of obefazimod leads to decreases in proinflammatory cytokines including IL-17 and IL-6 and the chemokine CCL2/MCP-1, thereby potentially putting a “physiological brake” on inflammation. It reverses the expression of several inflammatory cytokines without compromising host defense as it does not affect the immune response at all. These scientific findings may explain its short- and long-term efficacy along with a favorable tolerability and safety profile that were observed during Phase 2a and Phase 2b induction and maintenance clinical trials conducted in patients with UC.

Prof. Hartmut J. Ehrlich, MD, CEO of Abivax, said: “Abivax feels very encouraged by the data published in our article and by the validation and extension of obefazimod’s powerful new anti-inflammatory mechanism of action. The data complement our scientific findings released on our Phase 2a induction and maintenance clinical results and Phase 2b which were generated with obefazimod for the treatment of patients with moderate to severe ulcerative colitis. The article again supports the rationale that our lead molecule has the potential to efficiently, sustainably and safely treat i patients with UC.This specific MoA acts through the upregulation of a specific anti-inflammatory microRNA that reduces the expression of several pro-inflammatory cytokines.As a result, the excessive immune response leading to chronic inflammation of the gut can be balanced through continued treatment with obefazimod.We believe that obefazimod has the potential It is also likely to become an effective long-term therapy for other chronic inflammatory diseases with high medical need.”

About obefazimod

Abivax believes obefazimod is a highly differentiated oral drug candidate with a novel mechanism of action based on the upregulation of a single microRNA (miR-124) with potent anti-inflammatory properties. Obefazimod has been shown to exert its anti-inflammatory effects by binding to the cap binding complex (“CBC”), which is found at the 5′ end of every RNA molecule in the cell. By binding to the blood count, obefazimod enhances the biological functions of the blood count in cellular RNA biogenesis. Specifically, obefazimod enhances the selective splicing of a single long non-coding RNA to generate the anti-inflammatory microRNA, miR-124, which downregulates the translation of pro-inflammatory cytokines and chemokines such as TNF-α, IL-6, CCL2/MCP -1 and IL-17, as well as Th17+ cells. This downregulation therefore potentially ‘knocks off’ inflammation and suggests broad potential as a novel anti-inflammatory therapeutic agent. Laboratory analysis of the Phase 2b ulcerative colitis study at week eight showed highly statistically significant upregulation of miR-124 in rectal tissue in all obefazimod-treated patients compared to baseline. The median increases were 13-fold for the 25 mg group, 25-fold for the 50 mg group and 25-fold for the 100 mg group, while no upregulation was observed in the placebo group (1.02-fold increase), indicative of the positive pharmacological effect of obefazimod. Importantly, obefazimod does not affect cellular gene splicing.

Obefazimod for the treatment of adults with moderate to severe ulcerative colitis

Obefazimod is currently in a Phase 3 clinical trial for the treatment of ulcerative colitis (“ABTECT program”) with the first patient enrolled in the United States on October 11, 2022.

1,200 UC patients in 36 countries will participate in the Phase 3 pivotal program consisting of two induction studies (ABTECT-1 (ABX464-105) and ABTECT-2 (ABX464-106)) and a single subsequent maintenance study (ABX464 -107 ).

The ABTECT program aims to confirm obefazimod’s potential to maintain and further improve patient outcomes over time, as well as its favorable safety and tolerability profile, as already observed in previously conducted Phase 2a and Phase 2b clinical trials in colitis moderate to severe ulcerative.


About Abivax (www.abivax.com)

Abivax is a clinical phase 3 biotechnology company focused on developing therapies that modulate the immune system for the treatment of patients with chronic inflammatory diseases. Abivax, founded by Truffle Capital, is listed on Euronext compartment B (ISIN: FR0012333284 – Mnémo: ABVX). Based in Paris and Montpellier, Abivax’s lead drug candidate, obefazimod (ABX464), is in a Phase 3 clinical trial for the treatment of ulcerative colitis. 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) with respect to some of the Company’s programs. While Abivax’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks, contingencies and uncertainties, many of which are difficult to predict and generally outside control of Abivax, which could cause actual results and developments to differ materially from those expressed, implied or anticipated in the forward-looking information and statements. A description of these risks, contingencies and uncertainties is contained in the documents filed by the Company with the French Autorité des Marchés Financiers in compliance with its legal obligations, including the registration document (Document d’Enregistrement Universel). Such risks, contingencies and uncertainties include, among others, the uncertainties inherent in research and development, future clinical data and analyses, decisions by regulatory authorities, such as the FDA or EMA, regarding whether and when to approve any drug, as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such product candidates. Particular attention should be paid to potential pharmaceutical and clinical development barriers, including further evaluation by the company, regulatory agencies and IRBs/ethics committees following evaluation of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC data and clinicians. Furthermore, 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 statement, forecast or estimate to reflect any subsequent changes of which the Company becomes aware, except as required by law. Information about pharmaceutical products (including products currently in development) included in this press release is not intended to constitute advertising. This press release is for informational purposes only and the information contained herein does not constitute an offer to sell or the solicitation of an offer to buy or subscribe for any securities of the Company in any jurisdiction, particularly in France. Likewise, it does not and should not be treated as providing investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be viewed by addressees as a substitute for exercising one’s own judgment. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in some jurisdictions. Persons in possession of this document are required to inform themselves about and observe these restrictions.

[1] Apolit et al.: ABX464 (obefazimod) up-regulates miR-124 to reduce pro-inflammatory markers in inflammatory bowel disease, CTG, published online January 2023.


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