Regulatory Filings • Feb 22, 2019
Regulatory Filings
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PARIS (France), February 22, 2019 – 7:00 AM (CET) - Abivax (Paris:ABVX) (Euronext Paris: FR0012333284 – ABVX), a clinical-stage biopharmaceutical company harnessing the immune system to develop novel treatments for patients with inflammatory/autoimmune diseases, viral infections and cancer, today announced it will present its exciting clinical and mechanism of action data on a potential novel first-in-class approach to treating inflammatory diseases and HIV at two important upcoming conferences.
"We are very much looking forward to sharing with the scientific and investment communities further details on ABX464's mode of action and broad therapeutic potential," said Prof. Hartmut J Ehrlich, M.D., CEO of Abivax. "Our work on elucidating the mechanism of ABX464, initially shown to be the first treatment to reduce HIV reservoir in the blood and gut tissue of well-controlled HIV patients, revealed that this special molecule also exerts potent anti-inflammatory effects in patients. This discovery led us pursue a broad range of inflammatory diseases including ulcerative colitis, Crohn's disease, rheumatoid arthritis, multiple sclerosis and potentially other inflammatory diseases. In short, we believe ABX464 represents a truly exciting new first-in-class approach to treating inflammatory diseases that may make a major impact on patients' quality of life."
Today Prof. Jamal Tazi, Ph.D., VP Research at Abivax and Head of the Collaborative Abivax-CNRS Laboratory, will give a lecture at the 2019 Bermuda Principles – Impact on RNA Processing & Disease conference on new data on lead drug candidate ABX464, some of which was recently published in Nature Scientific Reports1 . The research characterizes ABX464's mechanism, showing that it selectively splices a long non-coding RNA (lncRNA 0599-205), thereby upregulating the anti-inflammatory microRNA miR-124. ABX464 also splices viral HIV RNA, but not endogenous cellular RNA in humans. These findings explain Phase 2 clinical and preclinical efficacy data showing that ABX464 may have broad potential to treat inflammatory diseases as well as HIV infection.
Next Monday, Prof. Hartmut J Ehrlich, MD, CEO of Abivax, will present to investors and potential partners the rationale for expanding from HIV testing into ulcerative colitis (UC) as well as analyses of recent clinical data from a successful Phase 2a trial in UC patients, at the 12th European Life Sciences CEO Forum in Zurich. In addition, during the conference, Dr Ehrlich has been invited to participate in panel discussion with leading investors and pharmaceutical executives entitled: Autoimmune and Inflammatory Diseases.
1 https://www.nature.com/articles/s41598-018-37813-y
ABX464 is a first-in-class small molecule for oral administration that has been tested in Phase 2a clinical trials for ulcerative colitis (UC) and HIV infection. In the proof-of-concept clinical trial in UC patients, ABX464 statistically significantly improved UC signs and symptoms on both clinical and endoscopic endpoints, achieving a clear and clinically meaningful magnitude of effect. Based on these ground-breaking data, Abivax is currently submitting the regulatory documents for a phase 2b clinical trial in 232 ulcerative colitis patients, and will initiate the regulatory submissions for phase 2a proofof-concept studies for two additional inflammatory indications, Crohn's disease and rheumatoid arthritis during the coming weeks.
Time/location: Friday, Feb 22 2019, 11:50-13:30 local time, Track Therapeutics, Fairmont Southampton, Bermuda
Title: Both anti-inflammatory and antiviral properties of novel drug candidate ABX464 are mediated by modulation of RNA splicing
Time/location: Monday, Feb 25 2019, 12:30-13:15, Room Panorama A, Zurich Hilton Airport Hotel (Switzerland)
Title: Autoimmune and Inflammatory Diseases
Time/location: Monday, Feb 25 2019, 14:15-14:30, Room Panorama C, Zurich Hilton Airport Hotel (Switzerland)
Title: Abivax Company Presentation
ABIVAX is mobilizing the body's natural immune machinery to treat patients with viral infections, autoimmune diseases and cancer. A clinical-stage company, ABIVAX leverages its antiviral and immune enhancing platforms to optimize candidates to cure HIV and treat inflammatory bowel diseases, as well as liver cancer. ABIVAX is listed on Euronext compartment B (ISIN: FR0012333284 – Mnémo: ABVX). More information on the company is available at www.abivax.com/en. Follow us on Twitter @ABIVAX_
Abivax Finance Didier Blondel [email protected] +33 1 53 83 08 41
French Media ALIZE RP Aurore Gangloff [email protected] +33 1 44 54 36 66
Investors LifeSci Advisors Chris Maggos [email protected] +41 79 367 6254
US Media LifeSci Public Relations Matt Middleman, M.D. [email protected] +1 646 627 8384
European Media & Investors MC Services AG Anne Hennecke [email protected] +49 211 529 252 22
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