Praxis Bioresearch said today it has won a $1.5 million Fast-Track Small Business Innovation Research (SBIR) grant from the NIH toward ongoing development of the company’s lead product candidate PRX-P4-003, a prodrug stimulant designed to significantly reduce the risk of abuse.

PRX-­P4-­003 is a novel, abuse-deterrent dopamine norepinephrine reuptake inhibitor incorporating an active isomer of fencamfamine (FCF). FCF is a Schedule IV stimulant that has been prescribed for decades in Europe and elsewhere overseas, primarily for depressive daytime fatigue, lack of concentration, and lethargy.

According to Praxis, PRX-­P4-­003 is specifically designed to produce therapeutic stimulant activity when delivered orally—but not if illicitly injected—since PRX-P4-003 is a substrate of pancreatic lipase, an enzyme whose activity is almost entirely restricted to the gut. That minimizes the potential for its oral abuse, the company reasons.

In a study presented at the 2017 Annual Meeting of the American College of Neuropsychopharmacology, held in Palm Springs, CA, and published in the journal Drug and Alcohol Dependence, orally-dosed PRX-P4-003 was shown to possess the established biological activity of stimulants, while pharmacokinetically limiting the potential for IV abuse in preclinical models. 

Praxis is initially developing PRX-P4-003 for the treatment of binge eating disorder. The company said it believes the prodrug could also treat apathy in Alzheimer’s disease patients, and plans to carry out a follow-on proof-of-concept study in that indication.

Alchem Laboratories will provide manufacturing services supporting Praxis’ ongoing development of PRX-P4-003.

“We believe that PRX-P4-003 may offer an innovative solution in providing patients the benefits of proven therapeutic stimulant activity with a significantly reduced risk of abuse,” Praxis CEO Sandeep Patil, Ph.D., M.D., said in a statement. “We are pleased to receive this highly competitive SBIR award as we work diligently to build upon our promising preclinical data.”

Praxis said PRX-P4-003 could address the unmet need for effective abuse-deterrent stimulant formulations since present-day stimulants are classified as Schedule II controlled drugs due to a significantly high risk of addiction.

The company cited a 2016 report by Persistence Market Research projecting that the stimulant market for ADHD alone will grow to $25 billion annually in 2024, based on a compound annual growth rate of 6.2%.

The SBIR Grant (R44MH116764) was awarded by the NIH’s National Institute of Mental Health.

Based in Menlo Park, CA, Praxis focuses on developing treatments for chronic neuropsychiatric and neurodegenerative disorders.