DGAP-News: ABIVAX Reports Positive Results of Phase 2a Study with ABX464 (ABX464-005) for the Treatment of HIV Infections (German)



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ABIVAX reports positive results from the Phase 2a study with ABX464 (ABX464-005) for the treatment of HIV infection

^ DGAP-News: ABIVAX / Word (s) Key (s): Results of the ABIVAX Reports Positive Study Results of the Phase 2a Study with ABX464 (ABX464-005) for the Treatment of HIV Infection

03.07.2018 / 08:00 The sender / publisher is responsible for the content of this announcement.


ABIVAX Reports Positive News Results of Phase 2a Study with ABX464 (ABX464-005) for the Treatment of HIV Infection

Prolonged Treatment with ABX464 Was Safe and Well Tolerated Decrease in total HIV DNA in the blood after prolonged treatment a decrease in HIV DNA in the intestinal tissue was observed in the Phase 2b study in the planning *** The ABX464's action mechanism was approved as a late summary for its presentation at the International AIDS Conference 2018 in Amsterdam

PARIS, July 3, 2018, 8:00 am MES Z-ABIVAX (Euronext Paris: FR0012333284 – ABVX) , a biotechnology company that uses the immune system to develop a functional cure for HIV, as well as treatments for inflammatory / autoimmune diseases and cancer, announced today positive results for the 2nd cohort of his study A BX464-005 Phase 2a for treatment of known HIV infection. The results and their communication were discussed before the press release with the Scientific Council of ABIVAX (ABIVAX).

ABX464-005, a phase 2a clinical trial, aims to evaluate the effects of ABX464 on the study of HIV DNA (HIV reservoir) in the blood and rectal tissue of patients completely. removed from the HIV virus in the blood.

The study was conducted at the University Hospital Germans Trias Pujol i Badalona in Barcelona, ​​Spain. In the first cohort of study ABX464-005, the nine patients received 150 mg of ABX464 daily for a period of 28 days. In this first cohort, eight out of nine patients between day 0 and day 28 showed a decrease (up to 52%) of HIV DNA in peripheral blood CD4 + T cells.

In the second cohort, 12 patients were matched 50 mg ABX464 daily for a period of three months, one-third of the first cohort dose to badess the potential of this low-dose to reduce the reservoir of blood and HIV tissue. Based on data available from week 12 (eight patients were studied at this time), four patients showed a decrease in total HIV DNA in CD4 + T cells. peripheral blood, ranging from 2% to 85%, while four patients experienced an increase in HIV DNA (5% to 36%).

Data from rectal tissue biopsies are also available for the first time. Four patients showed a decrease in HIV DNA (16% to 71%) in rectal tissue CD45 + T cells, while four patients noted an increase in HIV DNA (14% at 123%).

The data from the full cohort study will be submitted to future scientific conferences.

"These results show for the first time that ABX464 is capable of reducing HIV DNA in blood and rectal tissue reservoirs," said Dr. Jean-Marc Steens, Medical Director of the University of Toronto. ABIVAX. "The longer treatment duration of 12 weeks with ABX464 was safe and generally well tolerated, supporting prolonged use."

"Data from the second cohort of study ABX464-005 are both important and encouraging," Ian said. McGowan, professor of medicine at the University of Pittsburgh School of Medicine and chairman of the ABIVAX Scientific Advisory Board. "The results of the study show that some HIV-infected patients treated with ABX464 50 mg had a significant decrease in the HIV DNA reservoir, and other studies now identify the characteristics of patients with more likely to be affected by ABX464 in different benefits as monotherapy or in combination with other HIV cure strategies. "

Prof. Hartmut Ehrlich, CEO of ABIVAX, commented: "It is gratifying to see how ABX464's scientific approach is reflected in these data, which supports our plans for a Phase 2b trial and makes Advancing anti-HIV therapy. "

The molecular mechanism of ABX464 is the basis for the drug to become a therapeutic candidate for reducing the HIV reservoir in infected patients, and recent evidence sheds new light on the mechanism of HIV infection. ABX464 action. A related summary entitled "By binding to the CBC 80/20 complex, ABX464 enhances the splicing of pre-mRNA, leading to the formation of new RNA species." HIV-derived and increased expression of microRNA anti-inflammatory miR124 "(" ABX464, by binding the CBC 80/20 complex, improves pre-mRNA splicing, resulting in the generation of new species of 39 RNA derived from HIV and in an increase of "Expression of the anti-inflammatory miR124"), was accepted as a late defeat at the AIDS2018 Conference, The conference will be held in Amsterdam, from July 23 to 27, 2018.

L & # 39; Phase II clinical trial on ABX464 for the treatment of ulcerative colitis includes all patients, the last patients having completed the study this month. The frontline data for this study is expected to be available this fall.

ABIVAX (www.abivax.com) ABIVAX mobilizes the body's natural immune system to treat patients with viral infections, autoimmune diseases and cancer. ABIVAX, with drugs in clinical development, uses its technology platforms to identify and optimize antiviral drug candidates to cure HIV infection, and to treat inflammatory bowel disease and cancer of the liver. liver. ABIVAX is listed on Euronext Paris, Eurolist (compartment B).

For more information on the company, go to www.abivax.com

Follow us on Twitter @ABIVAX

Contacts

ABIVAX Finance Press Investors LifeSci Consultants Didier Blondel Relations Chris Maggos [1] didier.blondel@ab Europe ALIZE [1] [email protected] ivax.com +33 1 53 83 RP Aurore +41 79 367 6254 1. 08 41 1. Gangloff / mailto: chris @ lifesciadvisor mailto: didier .blon Caroline s.com [email protected] Carmagnol [1] abivax @ aliz erp.com +33 1 44 54 36 66 1. mailto: abiva [email protected]


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