Changing the Treatment Paradigm in Inflammatory Bowel Disease

Prof. Hartmut J. Ehrlich, MD, CEO of Abivax, explains why the drug candidate ABX464 has the potential to address the urgent need for new, safe and effective drugs in the short and long term to treat inflammatory bowel disease

Inflammatory Bowel Disease (IBD), such as ulcerative colitis and Crohn’s disease, are very debilitating and lifelong chronic diseases that require expensive and cumbersome therapy. The life of patients is marked by periods of relapses, during which they suffer from symptoms such as abdominal pain, diarrhea, weight loss, fever and anemia. Although the cause of these diseases is unknown, genetic factors, immune system dysfunction, changes in the normal gut microbiota, and environmental factors may play a role. These diseases have a heavy impact on the quality of life of patients as well as that of their families and friends, sometimes making normal private and professional life impossible.

The high number of non-responders to currently available therapies is the urgent need for new effective treatments

Although some progress has been made in recent years, finding a suitable and lasting treatment remains difficult and is a process of trial and error in which patients have to test various drugs, often experiencing different associated side effects. Additionally, only 10-20% of patients experience clinical remission (complete absence of symptoms) with currently available treatments, including biologics, and many stop responding after six to twelve months, with no options. treatment that might provide relief, other than colectomy. Therefore, the medical need for new therapeutic options to sustainably and effectively control IBD remains very high.

ABX464 – A First Class Anti-Inflammatory Drug Candidate With Promising Clinical Study Results

Abivax, a French clinical-stage biotechnology company listed on Euronext Paris (ABVX), has developed ABX464, a first-class anti-inflammatory drug candidate with a new and unique mechanism of action and simple oral administration once a day. ABX464 has already shown very promising results in a phase 2a and phase 2b clinical trial in moderate to severe ulcerative colitis (UC). The studies each consist of two parts: an eight-week induction phase, in which three different doses (25 mg, 50 mg or 100 mg) of ABX464 were tested, followed by a maintenance study. open label to assess the long-term efficacy of 50 mg ABX464 once a day. Based on the induction data, as well as the results of maintenance studies available to date, the molecule has the potential to effectively and sustainably treat patients with UC.

Rapid onset of action and long-term efficacy of ABX464 with a good safety profile

The results of the induction phases in both studies demonstrated a rapid onset of action as well as a potent anti-inflammatory effect of ABX464. The molecule has been shown to be effective in patients refractory to conventional treatments and, above all, also in patients with an inadequate response, a loss of response or an intolerance to biologics and / or to JAK inhibitors. Phase 2a and phase 2b maintenance studies are still ongoing, however, interim results show sustained and lasting efficacy.

It is important to note that ABX464 has been shown to be safe and well tolerated in induction and maintenance therapy. Recent data from the phase 2b induction study demonstrate similar infection rates in the active treatment groups compared to placebo and no deaths or malignancies were reported. The percentage of patients treated with ABX464 (25 mg, 50 mg or 100 mg) who experienced serious adverse events was at the same level or even lower than the percentage reported in the placebo arm.

This good safety profile has also been observed in patients in ongoing long-term trials. Patients in the phase 2a study are now in their fourth year of continuous once-daily treatment, while patients in the phase 2b study are gradually entering their second year of treatment.

With its new mechanism of action, ABX464 could be a game-changer for the treatment of IBD

In addition to its convenient once-daily oral administration, rapid onset of action, long-lasting and sustained efficacy and good safety profile, ABX464 also has a completely new and unique mechanism of action. The mechanism of action of this small, first-in-class molecule fundamentally differentiates it from any other drug or drug candidate in the inflammatory field. ABX464 has the ability to selectively upregulate miR-124, a potent anti-inflammatory microRNA, which down-regulates pro-inflammatory cytokines and chemokines, thereby “slowing down” inflammation. Thus, the molecule modulates the endogenous immune system to dampen inflammation and control symptoms.

ABX464 enters phase 3 clinical trials in ulcerative colitis

Following the encouraging results of induction and maintenance of phases 2a and 2b in UC, Abivax is currently preparing to start a phase 3 clinical program in UC. In addition, due to the clinical similarities between UC and Crohn’s disease (CD), the Company is also considering launching a pivotal phase 2b clinical study in this indication to assess the potential benefit of the drug candidate in patients with MC.

The potential of ABX464 in other chronic inflammatory indications

In addition to the IBD study program, Abivax is also testing ABX464 for the treatment of moderate to severe active rheumatoid arthritis (RA), another chronic inflammatory disease. In June 2021, Abivax announced excellent first results from the induction phase of its Phase 2a clinical study of ABX464 in RA.

Join Abivax at its UEG Week Virtual 2021 Industry Symposium on October 4 from 1:00 p.m. to 2:00 p.m. CEST

Abivax will host an industry symposium at UEG Week Virtual 2021 on Monday, October 4, 2021 at 1:00 p.m. to 2:00 p.m. CEST (7:00 a.m. to 8:00 a.m. EST) on “ABX464, a novel anti-inflammatory drug candidate for the treatment of ulcerative colitis “. Presentations on the continued need for new drugs in IBD and the potential of ABX464 to address it will be given by internationally renowned KOLs, Professor Bruce Sands, MD, MS and Professor William Sandborn, MD In addition, Didier Scherrer , PhD, Vice President R&D at Abivax, will discuss the differentiators of the new and unique mechanism of action of ABX464.

Abivax selected for UEG last minute summary presentation

Abivax has been selected for a late-breaking oral summary presentation on phase 2b clinical data of ABX464 in UC. The summary will be presented by Prof. Séverine Vermeire, MD, Ph.D. on Monday, October 4, 2021 between 10:30 am-11:30am CEST (4:30 am-5:30am EST).

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