Praxis Bioresearch Presents Positive Preclinical Data for Novel Prodrug Stimulant with Abuse-Deterrent Properties at ACNP Annual Meeting

MENLO PARK, Calif., Dec. 07, 2017 (GLOBE NEWSWIRE) — Praxis Bioresearch, a biopharmaceutical company focused on the discovery and development of novel therapeutics for chronic neuropsychiatric and neurodegenerative disorders, today reported positive preclinical data that demonstrated the desired pharmacokinetic (PK) profile and targeted activity for its lead product candidate, PRX-P4-003, a novel, abuse-deterrent prodrug stimulant.  PRX-P4-003 is being developed as a prodrug of fencamfamine, a well-tolerated Schedule IV stimulant that was formerly prescribed for decades in Europe and other countries, for a range of conditions including depressive daytime fatigue, lack of concentration, and lethargy. Praxis’ novel prodrug, which is selectively cleaved by gut enzymes, is designed to offer the therapeutic benefits of currently marketed stimulants, while reducing risk of abuse and diversion. These data were reported in a poster presentation at the annual meeting of the American College of Neuropsychopharmacology (ACNP), being held December 3-7, 2017, in Palm Springs, CA.

Presented study findings showed that prodrug PRX-P4-003 remained intact without releasing the parent compound (-)-FCF, a purified isomer of fencamfamine, when it was exposed to simulated gastric fluid. (-)-FCF was only released when the prodrug was metabolized following exposure to simulated intestinal fluid containing pancreatic enzymes. Importantly, data demonstrated that intact PRX-P4-003 lacked affinity for dopamine and norepinephrine transporters, whereas (-)-FCF demonstrated strong affinity for these key targets of stimulant therapy, as expected.  These findings suggest that orally dosed PRX-P4-003 possesses the desired profile to prevent rapid stimulant uptake and activity until it has passed through the stomach and reached the small intestine.

Once metabolized in the gut, orally dosed prodrug PRX-P4-003 demonstrated …

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