Praxis Bioresearch Presents Phase 0 Clinical Data for PRX-P4-003 at 14th Annual CTAD conference

Clinical Study Was Conducted in Healthy Volunteers to Demonstrate Oral Activation of PRX-P4-003 leading to systemic exposure of its parent drug (-)-fencamfamine 

Los Angeles, CA, November 09, 2021– Praxis Bioresearch reports Clinical Phase 0 study data (PBR001) to demonstrate the desired pharmacokinetic profile for its lead product candidate, PRX-P4-003 in healthy volunteers (NCT04638803). The primary goal of the PBR001 study was to determine whether there is a successful conversion of PRX-P4-003 to its active parent (-)-fencamfamine upon oral administration in humans. The PBR001 data are being reported in a virtual poster presentation format at the 14th Clinical Trials on Alzheimer's Disease (CTAD) meeting, being held November 9-12, in Boston, MA.

PRX-P4-003 is a new chemical entity (US Patent 10,662,146) designed by Praxis to provide a once-a-day drug to treat apathy caused by Alzheimer’s disease. Specifically, the objective of the molecular design of PRX-P4-003 is to deliver an active isomer of fencamfamine selectively bioavailable via the oral route only thus differentiating it from currently FDA-approved stimulants. The prodrug PRX-P4-003 serves as a substrate of pancreatic lipase, an enzyme whose biological activity is almost entirely restricted to the gut and thus is not expected to be activated by parenteral routes. 

CTAD accepted Presentation (#RP41):

Title: Microdose Study of a Novel Psychostimulant Prodrug, PRX-P4-003, with Reduced Abuse Liability for Apathy in AD

Presenting Author: William Z. Potter MD PhD, Praxis Bioresearch, Los Angeles CA, available to view on November 9, 2021.

About PRX-P4-003

PRX­P4­003 is a new chemical entity prodrug that incorporates an active isomer of fencamfamine [(-)-FCF], a well-tolerated Schedule IV stimulant.  Originally developed and marketed by E. Merck KG (Darmstadt, Germany) fencamfamine has a long-established clinical profile following decades of therapeutic use in European and other countries. Prodrug PRX-P4-003 was specifically designed to deliver fencamfamine isomer selectively by the oral route. Thus, limiting its stimulant activity to oral administration and differentiating it from other marketed stimulants. The profile is made possible due to PRX-P4-003 serving as a substrate of pancreatic lipase, an enzyme whose biological activity is almost entirely restricted to the gut.

Stimulants such as methylphenidate and amphetamines are among the most widely prescribed classes of medications, with an estimated 90 million annual prescriptions written for a range of central nervous system conditions including attention deficit hyperactivity disorder (ADHD), narcolepsy, and binge eating disorder. According to a report issued by Persistence Market Research, the stimulant market for ADHD alone is expected to grow to $25 billion annually in 2024. However, these two stimulants are classified as Schedule II controlled drugs due to a significantly high risk of addiction and/or diversion. PRX-P4-003 is designed to deter risk of abuse while maintaining efficacy as a stimulant. PRX-P4-003 eliminates the chance of active moiety absorption through any route other than the oral and has a pharmacokinetic profile that discourages any immediate effect of dopamine activity when released into in the bloodstream via the gastrointestinal tract.

About Praxis Bioresearch

Praxis Bioresearch, LLC, is a biopharmaceutical company focused on the discovery and development of therapeutics for chronic neuropsychiatric and neurodegenerative disorders. Praxis’s lead development candidate is PRX-P4-003, a novel prodrug stimulant designed to offer the proven clinical activity of currently marketed stimulants while reducing risk of abuse and addiction.  PRX-P4-003 is being developed for the treatment of binge eating disorder and apathy in Alzheimer’s Disease. For more information visit: www.praxisbioresearch.com.

Praxis Bioresearch Forward Looking Statements

The information contained in this press release is based on current expectations and beliefs of future events. Although forward-looking statements contained in this press release are based upon what management of Praxis Bioresearch believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Praxis Bioresearch assumes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.

Disclaimer: Research reported in this publication was supported by the National Institute of Mental Health of the National Institutes of Health under Award Number R44MH116764. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Contact: 

Rudi Ross

941-833-5700

info@praxisbioresearch.com