Praxis Bioresearch is a privately held biopharmaceutical company focused on the discovery and development of novel therapies for the treatment of a range of chronic neuropsychiatric and neurodegenerative disorders.
Our lead development candidate prodrug PRX-P4-003 is designed to offer a proven therapeutic approach to multiple neuropscyhiatric indications.
Apathy is the most common noncognitive symptom in Alzheimer’s Disease, affecting nearly 70% of the patients. Untreated apathy can lead to poor quality of life for the patient, rapid decline in cognition, and increased caregiver distress, and may result in costly early institutionalization
Recent clinical research demonstrates that apathy is responsive to a dopaminergic approach(1-3). Praxis has built upon these findings and developed PRX-P4-003, a novel prodrug of fencamfamine (a Schedule IV stimulant). PRX-P4-003 has a gut-based activation mechanism providing selective oral bioavailability and once-a-day dosing convenience. We have demonstrated PRX-P4-003 bioconversion to its active moiety (-)-fencamfamine in healthy volunteers under an Exploratory IND pathway.
Our lead development candidate, PRX-P4-003, is a steric acid conjugate of an active isomer of fencamfamine [(-)-FCF], created to provide an innovative, low-risk prodrug. Fencamfamine, a well-tolerated Schedule IV stimulant, has an established clinical and safety profile, having been formerly prescribed for decades in Europe and other countries for a range of indications(4,5).
PRX-P4-003 is designed to be activated by pancreatic lipase, an enzyme whose biological activity is mainly in the gut. Less than 1% of pancreatic lipase is active in the intravenous compartment.
Schematic of PRX-P4-003 Metabolism
PRX-P4-003 is biologically inactive and has to be enzymatically cleaved in the gut to release the parent drug (-)-FCF (a purified fencamfamine isomer), which is responsible for its stimulant-like effects.
Apathy in Alzheimer’s Disease and other chronic neuropsychiatric indications.
Praxis Bioresearch has a talented and proven collection of experts in prodrug design, neuroscience, chemistry, pharmacology and drug development. We have the scientific and business know-how necessary to manage efficient development of our lead development candidate, PRX-P4-003.
As a physician-scientist and a seasoned drug-developer, Dr. Patil has contributed to the preclinical and clinical development of novel therapeutics for nearly 15 years at pharmaceutical companies,...
Mr. Rick E. Winningham has been Chairman and Chief Executive Officer at Theravance Biopharma, Inc. since its spin-off from Theravance, Inc. (renamed Innoviva, Inc. in January 2016) in....
