Interim evaluation demonstrates best-in-class medical remission in 55.3% of 217 ulcerative colitis (UC) sufferers (full evaluation set) after 48 weeks of once-daily oral 50mg ABX464
Furthermore, within the subgroup of sufferers who had a minimum of a medical response after the 8-week induction research (n=121), 65.3% achieved medical remission through the first yr of upkeep therapy (full evaluation set)
Endoscopic enchancment and endoscopic remission at week 48 achieved by 61.8% and 33.6% of the sufferers respectively (full evaluation set)
Good security and tolerability profile helps continual use of ABX464
Last preparations to launch ABX464 world pivotal section 3 medical program in UC ongoing, inclusion of first sufferers is anticipated in Q3 2022
PARIS, FRANCE / ACCESSWIRE / April 6, 2022 / Abivax SA (Euronext Paris: FR0012333284 – ABVX), a clinical-stage biotechnology firm creating novel therapies that modulate the immune system to deal with continual inflammatory ailments, viral infections, and most cancers, as we speak experiences glorious outcomes from the Interim Evaluation of its section 2b open-label upkeep research, together with 217 sufferers who accomplished the one yr of once-daily oral therapy with 50mg ABX464. These knowledge emphasize ABX464’s capability to keep up and additional enhance patient-outcomes over time, in addition to its continued favorable security and tolerability.
Prof. William Sandborn, M.D., College of California San Diego College of Drugs and Co-Founder and Chief Medical Officer at Shoreline Biosciences, CA, stated: “The information of those sufferers handled for one yr on this section 2b upkeep research verify the earlier, optimistic observations made with ABX464 within the section 2a. At present, many sufferers cease responding or don’t reply in any respect to obtainable therapies. These outcomes are encouraging as they counsel that ABX464 can induce short-term and, extra importantly, keep and even enhance long-term efficacy in sufferers with in average to extreme ulcerative colitis. The nice security and tolerability profile seen within the section 2b can also be very encouraging.”
Prof. Bruce Sands, M.D., M.S., the Dr. Burrill B. Crohn Professor of Drugs on the Icahn College of Drugs at Mount Sinai, New York Metropolis, NY, added:“These upkeep knowledge point out that ABX464 could change the therapy paradigm for bio-naïve in addition to refractory ulcerative colitis sufferers. ABX464 confirmed a stable and sturdy efficacy sign together with a very good tolerability profile, which differentiates it from many different merchandise available on the market or in late-stage testing in UC. Past efficacy and security, ABX464 additionally presents handy once-daily oral administration.”
Prof. Hartmut J. Ehrlich, M.D., CEO of Abivax, stated: “We’re more than happy with the outcomes of the section 2b upkeep research with ABX464 after the primary yr of continued every day therapy. 65.3% of sufferers with a minimum of a medical response on the finish of induction had been in medical remission after one yr, which confirms the end result of the section 2a research with 66.7%. These are best-in-class outcomes, demonstrating that the distinctive mechanism of motion of our drug-candidate can induce excessive charges of sturdy medical remissions in sufferers affected by average to extreme ulcerative colitis. Together with the upkeep knowledge just lately reported from our section 2a trial in rheumatoid arthritis, these outcomes additional underpin the capability of ABX464 to successfully tackle a broad vary of continual inflammatory ailments. Abivax shall be initiating the ABX464 section 3 program in UC quickly, with a primary affected person to be included in Q3 2022. We wish to make this doubtlessly transformative drug-candidate obtainable as shortly as potential to sufferers affected by ulcerative colitis and probably additional continual inflammatory indications.”
ABX464 section 2b medical upkeep research in ulcerative colitis
97.7% (217/222) of all sufferers who accomplished the section 2b induction research, no matter remedies or therapy consequence through the induction section, enrolled within the open-label upkeep research to guage the long-term security and efficacy profile of ABX464 for as much as two years.
The interim evaluation after one yr of therapy from the section 2b open-label extension research in UC included all 217 sufferers who enrolled into the upkeep research with ABX464.
At week 48
Full evaluation set
n= 120 (55.3%)
n= 73 (33.6%)
Maintained medical remission at week 48
* Drop-outs (33 sufferers) had been thought-about as therapy failures within the full evaluation set.
Predominant efficacy endpoints in accordance with medical response standing at finish of the induction (week 8):
At week 48
Sufferers with medical response after induction
Sufferers with out medical response after induction
Among the many 217 sufferers who accomplished the primary yr of 50mg once-daily oral dosing with ABX464, 52 had entered the upkeep research already in medical remission. 38 (73.1%) out of those 52 sufferers stayed in medical remission throughout this primary yr of upkeep therapy. It’s outstanding that 82/165 (49.7%) sufferers who weren’t in medical remission on the finish of induction achieved a de novo medical remission through the first yr of upkeep.
Moreover, the medical remission price for sufferers who didn’t present a minimum of a medical response on the finish of the induction section was 42.7% (full evaluation set) after 48 weeks of therapy, demonstrating that long-term administration of ABX464 supplied substantial medical advantages additionally for these sufferers.
33/217 (15.2%) of sufferers dropped out through the first 48 weeks of the section 2b upkeep research. Worsening of UC was the first explanation for untimely research discontinuation (10 sufferers – 30%). These sufferers had been all thought-about as therapy failures within the full evaluation set.
Throughout the induction and the upkeep phases of the section 2b research, ABX464 continued to indicate a very good security and tolerability profile, confirming the information already generated in over 1,000 sufferers and volunteers handled with ABX464 thus far.
254 sufferers with average to extreme energetic ulcerative colitis had been enrolled into the section 2b medical research and dosed inside three once-daily oral ABX464 therapy teams (25mg, 50mg and 100mg) or placebo. 50% of those sufferers had insufficient response, lack of response, or intolerance to biologics and/or JAK inhibitor remedies whereas the opposite 50% had been refractory to traditional remedies. Endoscopies had been learn centrally and blinded by impartial reviewers. The baseline illness traits had been properly balanced throughout all ABX464 dose teams and the placebo group. Enrolled sufferers suffered from longstanding UC with an general imply illness length of 8.05 years and 71.4% of the sufferers confirmed a extreme illness profile (baseline modified Mayo Rating of seven to 9 factors).
Affect of the struggle in Ukraine on Abivax’s section 2b medical research
The ABX464 section 2b upkeep research in average to extreme UC sufferers is the one trial presently carried out by Abivax on Ukrainian territory. The analysis after 12 months of therapy had already been carried out for all Ukrainian sufferers previous to the outbreak of the struggle and are taken into consideration within the one-year outcomes offered on this press launch.
ABX464 section 1 medical research
Abivax conducts 4 section 1 research with ABX464 in wholesome volunteers, as a part of the same old observe throughout late-stage medical drug growth.
The affected person enrollment has been accomplished in all research and the information evaluation is progressing in accordance with plan.
The presently obtainable preliminary outcomes are all supportive in advancing ABX464 into the pivotal section 3 program.
ABX464 world pivotal section 3 medical program in ulcerative colitis
In December 2021 and January 2022 respectively, the US regulatory company (FDA) in addition to the European Medicines Company (EMA) expressed their assist in shifting ABX464 right into a pivotal section 3 program in average to extreme UC. The businesses raised no issues concerning medical security, non-clinical security, or CMC.
Each the FDA and EMA agreed with Abivax that progressing 25mg and 50mg (as the very best dose) into section 3 testing is acceptable for each induction and the following upkeep research in UC. The businesses had been supportive of Abivax’s intention to drop the 100mg dose, as no extra therapeutic profit could possibly be noticed with this larger dose.
Abivax is working with IQVIA, a worldwide premier CRO, to collectively set-up and conduct these research throughout Europe, the US, Japan and different world geographies. Given the present developments, Abivax determined that Ukraine, Russia and Belarus can’t be a part of the ABX464 world section 3 research program in UC.
At present, greater than 400 research websites, out of the focused 600 websites, already confirmed their participation within the section 3 trial and the enrollment of the primary affected person is deliberate for Q3 2022.
Acquisition of Prosynergia SARL
Abivax pronounces that it acquired on April 1, 2022, Prosynergia SARL, a Luxembourg biotech firm, so as to strengthen the Abivax growth portfolio, for an quantity of EUR 3.25M. The phrases of the transaction additionally embody potential earn-out funds for a most extra quantity of EUR 4M based mostly on the potential evolution of Abivax’s market capitalization.
About Abivax (www.abivax.com)
Abivax, a medical stage biotechnology firm, is creating novel therapies that modulate the physique’s pure immune equipment to deal with sufferers with continual inflammatory ailments, viral infections, and most cancers. Abivax is listed on Euronext compartment B (ISIN: FR0012333284 – Mnémo: ABVX). Primarily based in Paris and Montpellier, Abivax has two drug candidates in medical growth, ABX464 to deal with extreme inflammatory ailments, and ABX196 to deal with hepatocellular carcinoma. Extra data on the corporate is offered at www.abivax.com. Observe us on Twitter @ABIVAX_.
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 Prof. Bruce Sands is a paid marketing consultant for Abivax. He has not been compensated for any media work.
 Medical remission (per Modified Mayo Rating) is outlined as stool frequency subscore (SFS) <=1, rectal bleeding subscore (RBS) of 0 and endoscopic subscore <=1.
 Endoscopic enchancment is outlined as endoscopic subscore <=1.
 Endoscopic remission is outlined as endoscopic subscore = 0.
 Medical response (per Modified Mayo Rating) is outlined as a lower from baseline within the Modified Mayo Rating >=2 factors and >=30% from baseline, plus a lower in RBS >=1 or an absolute RBS <=1.
 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