X
Pharma Advancement
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development

    New Delivery Path Brings To Light Efficacy of Immunotherapy

    Nasal Spray Shows Its Effect Against New COVID Variants

    Mid-Point Regulatory Science Strategy Study Published By EMA

    AADC Inadequacy To Be Handled By A Novel Gene Therapy

    New Drug Explored For Epilepsy Gets $3M Funding In Australia

    Care Access Research Launches Alliance to Provide Infrastructure for COVID-19 Trials

    Faster Clinical Trial Nods Planned By The UK To Curb Issues

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    U.S. FDA Approves DARZALEX Split-Dosing Regimen

    EMA Keeping A Close Watch On Critical Medicine Shortages

    Pathways Laid Down By The CMS For Drug Price Negotiations

    Pathways Laid Down By The CMS For Drug Price Negotiations

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development

    New Delivery Path Brings To Light Efficacy of Immunotherapy

    Nasal Spray Shows Its Effect Against New COVID Variants

    Mid-Point Regulatory Science Strategy Study Published By EMA

    AADC Inadequacy To Be Handled By A Novel Gene Therapy

    New Drug Explored For Epilepsy Gets $3M Funding In Australia

    Care Access Research Launches Alliance to Provide Infrastructure for COVID-19 Trials

    Faster Clinical Trial Nods Planned By The UK To Curb Issues

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    Pharma Drugs Gain From Tardigrade Proteins, Says Research

    U.S. FDA Approves DARZALEX Split-Dosing Regimen

    EMA Keeping A Close Watch On Critical Medicine Shortages

    Pathways Laid Down By The CMS For Drug Price Negotiations

    Pathways Laid Down By The CMS For Drug Price Negotiations

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home Drug Development Clinical Trials

Abivax Enrolls First Ulcerative Colitis Patient In New ABX464 Proof-Of-Concept Clinical Trial

Yuvraj_pawp by Yuvraj_pawp
20th November 2017
in Clinical Trials

ABIVAX announced the enrolment of the first patient in the ABX464-101 proof-of-concept study of its lead product candidate ABX464 in subjects suffering from moderate-to-severe active ulcerative colitis.

ABX464-101 is a Phase 2a proof-of-concept study aimed at evaluating the safety and efficacy of ABX464 50 mg given once daily versus placebo in subjects with moderate-to-severe active ulcerative colitis who have failed or are intolerant to immunomodulators, anti-TNFα, vedolizumab and/or corticosteroids. This clinical study is being conducted in 18 centers in eight European countries: France, Belgium, Germany, Poland, Hungary, Czech Republic, Spain and Austria. Regulatory and ethics committee authorizations already have been obtained in Belgium, Hungary and France.

Professor Hartmut Ehrlich, M.D., CEO of ABIVAX, said: “Exciting preclinical and in vitro human data showing ABX464’s efficacy in infammatory bowel disease models led us to undertake this trial in patients with ulcerative colitis. For example, ABX464 raised IL-22 and miR124 levels in in vitro human immune cells by 50- and 10-fold, respectively, indicating that ABX464 has powerful anti-inflammatory properties and is potentially synergistic with some of the established therapies for ulcerative colitis.”

Thirty subjects will be enrolled and treated for eight weeks. The primary objective is to evaluate safety and tolerability of ABX464 in this indication. Several efficacy objectives including clinical and biologic remission and mucosal healing also are included in this study. A follow-up protocol was recently submitted allowing participating patients to be enrolled in a 12-month open label follow-up study.

The first patient was enrolled this week at the University Hospitals Leuven, Belgium. Top-line data are expected to be reported in the second half of 2018.

Dr. Jean-Marc Steens, M.D., Chief Medical Officer at ABIVAX, commented: “Launching this trial marks the start of a clinical research and development program that has the potential to positively impact the treatment options for patients suffering from IBD. The opportunity to study ABX464 in IBD inflammation came from clinical and preclinical anti-inflammatory effects observed in our research on this drug-candidate for treatment of HIV infection, where the HIV reservoir is the source of chronic inflammation.”

Prof Séverine Vermeire, Department of Gastroenterolog – University Hospitals Leuven, Departmental Chair Clinical & Experimental Medicine KU Leuven, Belgium and principal investigator of the study, commented: “We welcome the involvement of ABIVAX in this therapeutic area that still carries a tremendous unmet medical need. Well designed studies, looking at objective endpoints, such as study ABX464-101, are critical in order to identify new drugs that can further improve treatment options for our patients.”

About ABIVAX
ABIVAX is an innovative biotechnology company targeting the immune system to develop novel treatments for viral and inflammatory diseases as well as cancer. 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, which is currently explored through a phase 2a proof-of-concept clinical trials in ulcerative colitis In addition, ABIVAX is advancing a clinical stage immune enhancer for the treatment of cancer 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

Contacts
ABIVAX
Finance
Didier Blondel
didier.blondel@abivax.com
+33 1 53 83 08 41

Press Relations Europe
ALIZE RP
Caroline Carmagnol/Aurore Gangloff
abivax@alizerp.com
+33 6 64 18 99 59 / +33 1 44 54 36 65

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

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

Previous Post

Apceth Biopharma to Present at EHA-SWG Scientific Meeting

Next Post

Sobi begins phase 3 study evaluating safety and efficacy of anakinra to treat Still’s disease

Related Posts

Care Access Research Launches Alliance to Provide Infrastructure for COVID-19 Trials
Clinical Trials

Faster Clinical Trial Nods Planned By The UK To Curb Issues

22nd March 2023
Clinical Trials

Efficacy Shown On Cystic Fibrosis Patients In 4-Year Study

18th March 2023
Clinical Trials

Monash University In Australia Leads $15M Mitochondrial Clinical Trial Drive

18th March 2023
Clinical Trials

Default Eligibility Results In Better Clinical Trial Nods

10th March 2023
Clinical Trials

Temperature Stable TB Vaccine Gives Out Immune Response

10th March 2023
Clinical Trials

More Monitoring Required of Institutional Review Boards

24th February 2023
Next Post

Sobi begins phase 3 study evaluating safety and efficacy of anakinra to treat Still’s disease

Latest News

Drug Development

New Delivery Path Brings To Light Efficacy of Immunotherapy

1st April 2023
Cathay Cargo signs global airline partnership with Tower Cold Chain
Packaging & Logistic

Cathay Cargo signs global airline partnership with Tower Cold Chain

31st March 2023
Quotient Sciences completes integration of drug substance into Translational Pharmaceutics Platform
Facilities & Operation

£277m Funding Set To Benefit UK Life Sciences Manufacturing

31st March 2023
Drug Development

Nasal Spray Shows Its Effect Against New COVID Variants

27th March 2023
FDA Approvals

Mid-Point Regulatory Science Strategy Study Published By EMA

27th March 2023
Pharma Advancement

About Us

Pharma Advancement is a leading Pharma information centric website. On one side Pharmaadvancement.com has established itself as one of the most efficient and comprehensive source of Pharma information online, dedicated to providing decision makers in all the Pharma industry sectors with reliable, accurate and useful insights into happenings in the Pharma sector.

Qucik Links

  • Drug Development
  • Manufacturing
  • News
  • Events & Conferences
  • Newsletter Archive

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack

System

  • Search
  • Sitemap
  • RSS Feed

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In