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DGAP-News: ABIVAX / Key word(s): Half Year Results
Abivax presents first-half 2021 financial results and operations update
PARIS, France, September 23, 2021 - 6:00 pm (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, today announces its 2021 half-year financial results, as of June 30, 2021, and provides an update on its clinical development progress. The financial statements for the first half of 2021, approved by the Company's Board of Directors on September 21, 2021, have been audited and the certification report is being prepared by the Company's external auditors.
"2021 has been a particularly positive and eventful year for Abivax. We announced excellent phase 2b clinical top-line and subsequent full results for the treatment of ulcerative colitis patients as well as very promising data of the phase 2a study in rheumatoid arthritis, both conducted with our lead compound ABX464. It is particularly encouraging to see, that our one-year and three-year long-term data of the ongoing phase 2a and phase 2b open-label maintenance studies confirm the sustained efficacy as well as the continued good safety profile of ABX464 in UC patients. We are also pleased that our late breaking abstract on the UC phase 2b data has been selected for an oral presentation at this year's United European Gastroenterology conference. This is another external validation of the potential of ABX464 to become an efficient durable treatment for patients suffering from UC.", said Prof. Hartmut J. Ehrlich, M.D., CEO of Abivax.
He continued: "Additional laboratory analyses now also reinforce the novelty and differentiation factors of the mechanism of action of ABX464 with a statistically significant upregulation of miR-124, a specific, physiologic, anti-inflammatory microRNA, observed in rectal tissues of patients across all dose groups. With these very positive clinical results and laboratory data, Abivax engaged in advanced interactions with the relevant regulatory authorities to launch its priority phase 3 clinical program with ABX464 in ulcerative colitis as quickly as possible. There is an urgent need for long-term efficacious and safe new drugs in the field of inflammatory bowel diseases. The entire Abivax team and its scientific advisory board are committed to take ABX464 to the finish line and provide the many patients suffering from these very debilitating chronic diseases with a new, potent and well-tolerated therapeutic management option."
Didier Blondel, CFO of Abivax, added: "Abivax successfully secured EUR 85M major financing in July under attractive terms, with the pricing of an oversubscribed capital increase of EUR 60M and convertible bonds of EUR 25M. With our current and available cash resources, together with the planned outcome of the prioritization of our clinical development activities for ABX464, our operations are expected to be funded until the end of Q3 2022. We are now carefully evaluating the strategic possibilities for the Company. Our strategic priority remains a potential partnering with a large pharma or biotech company, under the premises that the full potential of ABX464 in inflammatory bowel diseases as well as in the entire chronic inflammatory field is taken into account. As an alternative strategic option, we are also looking into additional financing opportunities, notably in the US and in Europe, that would maximize shareholder value."
* Excluding items of the liquidity contract (liquidity and own shares) and deposits & guarantees
ABX464 phase 2b clinical induction study in ulcerative colitis
Consistent with the other clinical studies, ABX464 was found to be safe and well tolerated at all dose levels during the 8-week and 16-week induction period. Within the ABX464 phase 2b induction study, the most frequently reported adverse events were mild and transient (i.e. headache, nausea, gastrointestinal pain) and manageable with or without over-the-counter medication.
Additional laboratory analyses also confirm the novel mechanism of action of ABX464, which fundamentally differentiates this first in-class small molecule from any other drug or drug-candidate in the inflammatory field. It is based on the upregulation of a single physiological microRNA (miR-124), a potent down-regulator of key pro-inflammatory cytokines and chemokines, thereby "putting a brake" on inflammation. A highly statistically significant upregulation of miR-124 could be detected in rectal tissue in all patients treated for 8 weeks with ABX464, compared to baseline. This observation underpins the potential of ABX464 to become a safe short- and long-term efficient treatment option in UC and potentially additional inflammatory indications. In the phase 2b clinical study, 254 patients with moderate to severe active ulcerative colitis were enrolled into the trial and dosed with three once-daily oral ABX464 treatment groups (25mg, 50mg and 100mg) or placebo. 50% of these patients had inadequate response, loss of response, or intolerance to biologics and/or JAK inhibitors treatments while the other 50% were refractory to conventional treatments. Endoscopies were read centrally and blinded by independent reviewers. The baseline disease characteristics were well balanced across all ABX464 dose groups and the placebo group. Enrolled patients suffered from longstanding UC with an overall median duration of 5.45 years and 71.4% of the patients showed a severe disease profile (baseline modified Mayo Score of 7 to 9 points).
ABX464 phase 2b clinical maintenance study in ulcerative colitis
In this maintenance study, ABX464 continues to show a good safety and tolerability profile.
Additional phase 2b maintenance results including the first 101 patients who completed 48 weeks of daily treatment with ABX464 will be made public in the late-breaking abstract presentation on October 4, given by Prof. Séverine Vermeire, principal investigator of the study, at the UEG Week Virtual 2021.
ABX464 phase 2a study in ulcerative colitis: Update on ongoing maintenance trial
Among the 13 patients who underwent centrally read endoscopies at the completion of year 3, 11 patients (85%) were still in clinical remission, among which 7 patients (54%) had an endoscopic remission (endoscopic subscore=0) and 11 patients had an endoscopic improvement (endoscopic subscore=0 or 1).
The long-term safety profile of chronic ABX464 administration continues to be very favorable.
Launch of ABX464 global phase 3 clinical development program in ulcerative colitis
ABX464 phase 2a clinical study in rheumatoid arthritis (RA)
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 ACR20is the key primary efficacy endpoint required by the FDA for licensure of new drugs in rheumatoid arthritis.
Following the positive results of the phase 2a trial, entering into the next stage of clinical testing in RA will depend on the outcome of Abivax's clinical development prioritization.
ABX464 in Crohn's disease (CD)
However, the initiation of the clinical trial in CD will depend on the outcome of Abivax's clinical development prioritization.
ABX464 phase 1 clinical studies
The four studies will provide additional data required to support Abivax in seeking approval from the regulatory authorities for its late-stage clinical development program of ABX464, starting with UC.
ABX464 potential market in inflammatory diseases
For rheumatoid arthritis, there were an estimated 3.8M diagnosed cases in G7 countries in 2020. 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. The overall chronic inflammation market is estimated to exceed USD 110B at that time.
Prioritization of clinical study programs
ABX196 in hepatocellular carcinoma (HCC)
Currently, the data consolidation of dose escalation phase for which the last patient has been enrolled in June this year, is underway.
Given a positive outcome of the analysis, the Company will decide on next steps, depending on the availability of the required financing or the opportunity of a licensing agreement.
Stopping of ABX464 clinical study in Covid-19 and Bpifrance financing
Exit conditions of the Bpifrance agreement relating to the funding of this program are being finalized. In total, Abivax and its academic partner CHU Nice are expecting to benefit from a total funding of EUR 22M (EUR 11M in grants for each partner), which would properly cover the dedicated expenses relating to this program.
UEG Week Virtual 2021 - Abivax late-breaking abstract presentation and live symposium
In addition, Abivax will be hosting an Industry Symposium at the UEG Week Virtual 2021 on Monday, October 4, 2021 at 1:00-2:00 pm CEST (7:00-8:00 am EST) on "ABX464, a novel anti-inflammatory drug-candidate for the treatment of ulcerative colitis". Presentations on the continued need for novel drugs in IBD and the potential of ABX464 to address them will be given by the internationally renowned key opinion leaders Prof. Bruce Sands, M.D., M.S. and Prof. William Sandborn, M.D. In addition, Didier Scherrer, Ph.D., Vice-President R&D at Abivax, will provide more details on the novel and unique mechanism of action of ABX464.
UEG Week Virtual subscribers can follow the live symposium and view the subsequently provided on-demand replay under the following link: https://virtualweek.ueg.eu/symposium/is-10
Jean-Marc Steens, M.D., has decided to end his career at Abivax
About Abivax (www.abivax.com)
 Clinical remission (per Modified Mayo Score) is defined as stool frequency subscore (SFS) <=1, rectal bleeding subscore (RBS) of 0 and endoscopic subscore <=1.
 Modified Mayo Score refers to stool frequency, rectal bleeding and endoscopy sub score.
 Endoscopic improvement is defined as endoscopic subscore <=1.
 Clinical response (per Modified Mayo Score) is defined as a decrease from baseline in the Modified Mayo Score >=2 points and >=30% from baseline, plus a decrease in RBS >=1 or an absolute RBS <=1.
 J. Tazi et al.: Specific and selective induction of miR-124 in immune cells by the quinoline ABX464: a transformative therapy for inflammatory diseases, Drug Discovery Today, Volume 26, Issue 4, April 2021, Pages 1030-1039
 Intent-to-treat patient population
 S. Vermeire et al.: Induction and long-term follow-up with ABX464 for moderate-to-severe ulcerative colitis: Results of phase 2a trial, Gastroenterology, March 2021
 The American College of Rheumatology ACR score measures the efficacy of treatments for rheumatoid arthritis patients. The ACR20/50/70 measures a 20/50/70% improvement in the tenderness and swelling in designated joints and a 20/50/70% improvement in at least 3 of the 5 following measures: investigator's and patient's reported global assessment of disease scales, patient's reported pain scale, CRP level, health assessment questionnaire.
 Source: Informa
23.09.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.