Grant fully funds manufacture of clinical supplies for Phase 2b clinical study and supports initiation of development of new subcutaneous formulation of IXT-m200
Little Rock, AR (01 May 2020) – InterveXion Therapeutics, a private clinical-stage biopharmaceutical company, today announced the award of additional Federal funds to support ongoing development of IXT-m200 (an anti-methamphetamine antibody) for patients with methamphetamine use disorder. The funds will be used in part to manufacture clinical trial supplies for a future Phase 2b clinical study of IXT-m200, as well as to fully fund initiation of a new program to develop a novel, more patient-friendly subcutaneous formulation of IXT-m200.
The three-year $8.4 million grant award comes from the National Institutes of Health/National Institute on Drug Abuse (NIH/NIDA) which has funded previous development of IXT-m200. A sub-award to the University of Arkansas for Medical Sciences (UAMS) is part of the grant, and UAMS will continue to play an important role in the advancement of IXT-m200 development. InterveXion is a BioVentures, LLC company housed on the UAMS campus in Little Rock, AR.
IXT-m200, a monoclonal antibody that specifically binds methamphetamine in the blood, is being developed as a pharmacological treatment for use in conjunction with behavioral therapy. InterveXion has released positive data from a pre-specified interim data evaluation from its ongoing Phase 2 STAMPOUT study of IXT-m200 in people who use methamphetamine, and final top-line data from STAMPOUT are expected later this year.
“We continue to be grateful for the support provided by NIDA for our development program,” said Keith Ward, Ph.D., InterveXion’s Chief Executive Officer. “Methamphetamine use disorder and methamphetamine overdose are now widely recognized as major public health issues in the US and around the world, and we are excited about the potential for IXT-m200 to potentially be used to help patients struggling with this powerful addiction”.
Misty Stevens, Ph.D. and W. Brooks Gentry, M.D. are the co-principal investigators on the new grant. Dr. Stevens is InterveXion’s Chief Operating Officer, and has significant experience in managing Federally funded projects, including the company’s previous and ongoing grants. Dr. Gentry is a co-founder and Chief Medical Officer of InterveXion. He is also a Professor of Anesthesiology and Pharmacology & Toxicology and holds the Wilbur D. Mills Chair in Alcohol and Drug Abuse Studies at UAMS.
InterveXion is the leading biopharmaceutical company developing immunotherapies for patients with methamphetamine use disorder. InterveXion’s lead product, IXT-m200, is a monoclonal antibody against methamphetamine which has received US FDA Fast Track Designation and which is currently undergoing Phase 2 clinical testing in the STAMPOUT study (NCT0333866). For more information, visit: https://www.intervexion.com.