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Abivax S.A.. (9/20/17). "Press Release: Abivax Receives French Regulatory Approval to Begin Clinical Trial of ABX464 in Ulcerative Colitis". Paris.

Region Region France
Organisations Organisation Abivax S.A. (Euronext Paris: ABVX)
  Group Abivax (Group)
  Organisation 2 University Hospital Leuven (UZ Leuven)
  Group K.U. Leuven (Katholieke Universiteit Leuven) (BE)
Products Product ABX464 (Abivax)
  Product 2 clinical research
Persons Person Ehrlich, Hartmut J. (Abivax 201410 CEO before Baxter BioScience 200712 VP Global RnD)
  Person 2 Steens, Jean-Marc (Abivax 2015– CMO)
     


Initiating Phase 2a study in fourth quarter of 2017


ABIVAX (Euronext Paris: FR0012333284 – ABVX), an innovative biotechnology company targeting the immune system to eliminate viral diseases using its unique antiviral technology platform, today announced that the French National Regulatory Authority (ANSM) has approved the ABX464-101 Phase 2a “Proof-of-Concept” study of its lead product candidate ABX464 in patients with moderate to severe active ulcerative colitis.

Professor Hartmut J. Ehrlich, M.D., CEO of ABIVAX, said: “Preclinical data published in Nature Scientific Reports1 show ABX464 dampened intestinal inflammation by triggering IL-22 production. As a result, we believe there is significant potential for the compound to be effective in patients with inflammatory bowel diseases (IBD). We are looking forward to initiating this study in the fourth quarter of 2017 and expect top-line data in the second half of 2018.”

ABX464-101 is a Phase 2a study aimed at evaluating the safety and efficacy of ABX464 in 30 patients with ulcerative colitis who have failed or are intolerant to immunomodulators, anti-TNFa, vedolizumab and/or corticosteroids. Patients will be randomized to receive either ABX464 50mg or placebo given once daily for eight weeks. Exploratory objectives include assessing the clinical remission and mucosal healing of the ulcerative colitis lesions. This clinical study will be conducted in seven European countries: France, Belgium, Germany, Poland, Hungary, Czech Republic and Spain. Regulatory and ethics committee approvals are being sought in all these countries.

Professor Severine Vermeire, M.D., Department of Gastroenterology - University Hospitals Leuven, Departmental Chair Chronic Diseases, Metabolism & Ageing, KU Leuven, Belgium and principal investigator of the study commented: “We are looking forward to the start of this study, as ulcerative colitis still carries a large unmet medical need. Clinical research with new drug candidates is greatly needed to further improve treatments.”

Jean-Marc Steens, M.D., chief medical officer of ABIVAX added: “This first clinical study with ABX464 in ulcerative colitis is a critical step to demonstrate the clinical relevance of the anti-inflammatory proprieties of ABX464. This demonstration may have clinical implications not only for patients with IBD, but also for patients with HIV who typically suffer from complications related to inflammation around the viral reservoirs.”


1 Please find the Nature Scientific Reports article using the following link:
https://www.nature.com/articles/s41598-017-04071-3


About ABIVAX (www.abivax.com)

ABIVAX is an innovative biotechnology company focused on targeting the immune system to eliminate viral disease. ABIVAX leverages three technology platforms for drug discovery: an anti-viral, an immune enhancement, and a polyclonal antibody platform. ABX464, its most advanced compound, is currently in Phase 2 clinical trials for providing a sustained viral remission or functional cure for patients with HIV/AIDS. It is a first-in-class oral small anti-viral molecule which blocks HIV replication through a unique mechanism of action and also has a strong anti-inflammatory effect. In addition, ABIVAX is advancing a clinical stage immune enhancer as well as multiple preclinical candidates against additional viral targets (e.g. Respiratory Syncytial Virus (RSV), Influenza and Dengue), and several of these compounds are planned to enter clinical development within the next 18 months. ABIVAX is listed on Euronext compartment B (ISIN: FR0012333284 – Mnémo: ABVX). More information on the company is available at www.abivax.com.

Follow us on Twitter @ABIVAX_


Contacts

ABIVAX

Finance
Didier Blondel
didier.blondel@abivax.com
+33 1 5383 0841

Investors
LifeSci Advisors
Chris Maggos
chris@lifesciadvisors.com
+41 79 367 6254

French Media
ALIZE RP
Caroline Carmagnol/Margaux Pronost
abivax@alizerp.com
+33 6 6418 9959 / +33 1 4454 3665

US Media
LifeSci Public Relations
Matt Middleman, M.D.
matt@lifescipublicrelations.com
+1 646 627 8384

   
Record changed: 2017-10-02

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