Addresses Major Global Unmet Medical Need in Addiction Therapy
Lead Asset, IXT-m200, has Received US FDA Fast-Track Designation
IXT-m200 Advancing into Phase 2 Clinical POC Study in 1H18
Parallel Phase 3-Enabling Multiple Dose Clinical Study Initiating in 1H18
Little Rock, Arkansas and Tokyo, Japan – InterveXion Therapeutics, LLC, a biopharmaceutical company focused on developing novel therapies to treat drug addiction, and Ascent Therapeutics, Co., Ltd., a company dedicated to advancing Asian development of promising therapeutics, today announced that they have entered into an agreement under which Ascent will license exclusive rights to develop and commercialize InterveXion’s lead compound, IXT-m200, in Japan and other Asian markets. Under the terms of the agreement, Ascent will receive rights to IXT-m200 in Asia, and will collaborate with InterveXion on certain clinical development activities and key regulatory interactions in the Asian territory.
IXT-m200 is a monoclonal antibody against methamphetamine which acts by partitioning methamphetamine away from its sites of action in the CNS. IXT-m200 is being developed for use in conjunction with conventional behavioral therapy for the treatment of methamphetamine abuse and has received US FDA Fast-Track Designation for this indication. If successful, it is expected that IXT-m200 will allow methamphetamine users to better adhere to behavioral therapy resulting in lower rates of recidivism. InterveXion recently announced full US NIDA funding for its upcoming Phase 2 proof-of-concept study for IXT-m200 (STAMPOUT) which is expected to initiate in 1H18.
“We are looking forward to collaborating with Ascent to bring IXT-m200 to market for the very large numbers of people in Asia who suffer from methamphetamine addiction,” said W. Brooks Gentry, M.D., Chief Medical Officer of InterveXion. “There are no approved pharmacologic therapies for methamphetamine addiction, and we are excited to partner with Ascent to accelerate global development of IXT-m200.”
“IXT-m200 has the potential to address an important unmet medical need as a well as a serious social problem afflicting Asian countries. It is an honor that InterveXion selected Ascent as their Asian partner” remarked John Winebarger, CEO of Ascent Therapeutics. “This collaboration is an example of how Ascent can leverage our Asian development expertise to enable Asian development in parallel to the US/EU and significantly enhance the value of the products of innovative biotech companies without a base in Asia.”
Under the terms of the agreement, InterveXion and Ascent will contribute specific development resources for the advancement of IXT-m200, and in return Ascent will receive exclusive Asian rights to the molecule. Ascent and InterveXion are both eligible to receive certain downstream payments associated with further development milestones in their territories.
About Methamphetamine Addiction
Methamphetamine abuse and addiction is a major global health crisis, with methamphetamine being the second most common drug of abuse in the world. Methamphetamine is highly addictive, is prevalent in the US, EU, and Asia, and is associated with a very high associated medical, legal, and social burden in virtually every country. Currently, there are no available approved medications for methamphetamine addiction. Methamphetamine produces complex psychiatric and medical adverse effects, along with its devastating social and economic consequences. The most successful approach today for treating methamphetamine addiction is admission to rehabilitation, with counseling services; however, success rates for such approaches are very low. Pharmacologic therapies to treat methamphetamine addiction would be extremely useful, but because of the highly addictive nature of this drug and its complex pharmacology, no such treatments currently exist.
About InterveXion Therapeutics
InterveXion was founded as a Bioventures, LLC, company at the University of Arkansas for Medical Sciences in Little Rock, Arkansas. The company has a stated goal of developing immunotherapies for treating drug abuse. InterveXion is funded extensively by non-dilutive grants from the National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA). InterveXion’s first medications are a monoclonal antibody and an active vaccine for treating methamphetamine abuse. For more information see http://www.intervexion.com.
About Ascent Therapeutics
Ascent Therapeutics is a privately-held, Tokyo-based, specialty pharmaceutical company. Ascent leverages its extensive global product development expertise and Asian footprint to efficiently develop innovative therapies in areas of high unmet medical need. Ascent is actively seeking partnerships and collaborations for innovative product candidates that can be developed in Asia for global markets. For more information see http://www.ascenttherapeutics.com.
Misty Stevens, Ph.D.
Chief Executive Officer