InterveXion receives federal grants for development of drug therapies to treat methamphetamine users

A University of Arkansas for Medical Sciences (UAMS) BioVentures startup company, InterveXion Therapeutics LLC, has received two federal grants totaling $14.5 million for development of drug therapies that can help methamphetamine drug abusers break their addiction.

The therapies are designed to reduce or prevent the euphoric rush that drug users crave by keeping methamphetamine in the bloodstream and out of the brain, where the drug exerts its most powerful effects.

The larger of the two grants, $9.55 million over three years, will support research that will determine whether a methamphetamine vaccine may be safely advanced into a clinical trial with human participants. The vaccine is a promising new strategy that could stimulate a patient's own immune system to generate long-acting, protective anti methamphetamine antibodies.

The other grant of $5 million over three years will support production of the anti-methamphetamine monoclonal antibody that has been successfully tested in a first clinical study of healthy adults. The grant will also fund more research to show that the antibody is safe for methamphetamine users. The additional study will prepare researchers for the next clinical trial involving methamphetamine-using participants.

This antibody does not stimulate the immune system, but it selectively and quickly binds methamphetamine in the blood and prevents it from entering the brain and other tissues where it causes multiple health problems, including addiction. It would be the first medication that can reduce methamphetamine's effects for prolonged periods of time.

The antibody has an immediate impact on the user and is effective for about a month. The vaccine takes several weeks to become effective, and it may blunt methamphetamine's effects for nine months or longer. A first-phase study of the antibody in healthy adults recently found no safety or tolerability concerns. Published in mAbs Journal in December, the results are from the first clinical trial of the antibody ch-mAb7F9 in a paper titled, "First human study of a chimeric anti-methamphetamine monoclonal antibody in healthy volunteers."

Both grants are to InterveXion from the National Institutes of Health (NIH) National Institute on Drug Abuse (NIDA). UAMS is a sub-awardee.

"These grants represent NIDA's commitment to addressing methamphetamine abuse with promising therapies such as the monoclonal antibody and vaccine," said UAMS' Mike Owens, Ph.D., who developed both the vaccine and the antibody and has received NIDA funding since the mid-1980s.

"Our team demonstrated the safety of the monoclonal antibody in a clinical trial completed last year, and we look forward to the next phases of research with both the antibody and the vaccine," he said.

Owens is co-program director and co-principal investigator on the vaccine grant. He is a professor and director of the UAMS Center for Alcohol and Drug Abuse and InterveXion's chief science officer.

W. Brooks Gentry, M.D., is co-program director and co-principal investigator on the monoclonal antibody grant. He is a professor and chair of the Department of Anesthesiology in the UAMS College of Medicine and InterveXion's chief medical officer.

Misty Stevens, Ph.D., M.B.A., is operations director for InterveXion and is co-program director and co-principal investigator for both grants. Ralph Henry, Ph.D., is vice president for biopharmaceutics at InterveXion and a co-investigator on both grants.

Assuming the antibody and vaccine receive federal Food and Drug Administration (FDA) approval, they can be provided as an integral part of a methamphetamine user's complete treatment program, which consists of counseling and possibly other medications to reduce craving.

"The two drug therapies may also be used together," Stevens said. "The antibody could provide a patient with immediate protection while the patient is building immunity following administration of the vaccine."

Neither the monoclonal antibody nor the vaccine should interact with other medications, nor should they impact brain function or interfere with psychiatric counseling. The vaccine would be less expensive than the antibody, but it is expected to be less effective for some people, especially those with compromised immune systems.