InterveXion to Present Positive Phase 2 STAMPOUT Study Data at Upcoming CPDD Meeting
STAMPOUT is the first positive Phase 2 proof-of-concept trial for an anti-METH antibody
LITTLE ROCK, ARKANSAS, USA, April 4, 2022 /EINPresswire.com/ -- InterveXion Therapeutics, a private clinical-stage biopharmaceutical company, today announced that it has been selected to present the positive data from its recently completed STAMPOUT study at the 2022 College on Problems of Drug Dependence in Minneapolis, Minnesota on June 11-15, 2022. STAMPOUT was a Phase 2 proof-of-concept study studying IXT-m200 in patients with methamphetamine use disorder. 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 therapies.
The positive Phase 2 STAMPOUT data allowed us to launch our follow-on Phase 2 studies, Meth-OD and OUTLAST, and we are excited to share our progress at the upcoming CPDD meeting”.”— Keith Ward, Chief Executive Officer, InterveXion
In STAMPOUT, IXT-m200 achieved the primary endpoint, and significantly (p<0.0001) altered methamphetamine AUC and Cmax, up to 30-fold and 8-fold respectively, without altering methamphetamine renal elimination. Favorable trends in several secondary endpoints associated with the pharmacodynamic effects of methamphetamine were also observed. IXT-m200 was well-tolerated, with no serious adverse events and no unexpected adverse events.
Dr. W. Brooks Gentry, InterveXion’s Chief Medical Officer, will present the IXT-m200 STAMPOUT clinical data in the following sessions:
“New Results from Phase 2 Trials of IXT-m200, a High-Affinity METH Antibody”, Symposium Session entitled 'The Best Offense is Defense! Blocking and Tackling Stimulants in the Periphery to Prevent CNS Action' (Chaired by Dr. Katrina Foster, Division of Therapeutics and Medical Consequences, NIDA) June 13, 10:00 am CT
“STAMPOUT: Impact in Humans of IXT-m200 (a High-Affinity Methamphetamine Antibody) on Methamphetamine Concentrations and Effects”, Oral Presentation, June 15, 4:30 pm CT
“We are grateful to have been selected to present our program at the College on Problems in Drug Dependence”, noted Dr. Keith Ward, InterveXion’s Chief Executive Officer. “The positive Phase 2 data from STAMPOUT have allowed us to proceed in parallel into our next two Phase 2 studies, Meth-OD and OUTLAST, and we are excited to discuss our progress towards the development of therapies for patients suffering from methamphetamine use disorder with the scientific community”.
STAMPOUT (NCT03336866) was funded by a three-year, $8 million grant award (U01DA045366) from the National Institutes of Health/National Institute on Drug Abuse (NIH/NIDA). InterveXion has subsequently been awarded $8.1 million in NIDA funding for the Meth-OD Phase 2 study in methamphetamine overdose (U01DA053043), and $13.8 million for the OUTLAST Phase 2 study in methamphetamine use disorder (U01DA055481).
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 with positive Phase 2 data and which has received US FDA Fast Track Designation for treatment of methamphetamine use disorder. For more information, visit https://www.intervexion.com.