fencamfamine prodrug (PRX-P4-003) / Praxis Bioresearch - LARVOL DELTA

Praxis Bioresearch Obtains FDA Clearance On the IND Application for Its Lead Candidate PRX-P4-003 In Alzheimer’s Disease Apathy (GlobeNewswire) - "Praxis Bioresearch reports that the United States Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for PRX-P4-003, a gut-activated stimulant, to treat apathy in Alzheimer’s Disease."

IND • Alzheimer's Disease • CNS Disorders

[VIRTUAL] Microdose Study of a Novel Psychostimulant Prodrug, PRX-P4-003, with Reduced Abuse Liability for Apathy in AD (CTAD 2021) - "PRX-P4-003 is converted in humans to pharmacologically active (-)-FCF which is detected in plasma consistent with predictions from preclinical studies. The finding of a much earlier peak concentration in the fed state is consistent with the postulated dependence of release of pancreatic lipases into the gut following ingestion of food. The properties of PRX-P4-003 shown in this microdose study support its further development for the treatment of apathy in AD as a drug with at least equivalent efficacy to methylphenidate and a lower liability of abuse or diversion."

Microdose Pharmacokinetic Study of PRX-P4-003 In Healthy Volunteers (clinicaltrials.gov) - P1; N=6; Completed; Sponsor: Praxis Bioresearch, LLC; Active, not recruiting ➔ Completed

Clinical • Trial completion

Praxis Bioresearch Presents Phase 0 Clinical Data for PRX-P4-003 at 14th Annual CTAD conference (GlobeNewswire) - "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 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."

Clinical data • Alzheimer's Disease • CNS Disorders

Praxis Bioresearch Seeks Regulatory Strategy Support from MMS Holdings to Develop Therapeutics for Alzheimer’s Disease (Businesswire) - “MMS Holdings (MMS)…provided regulatory strategy support to Praxis Bioresearch in the development of a therapeutic for apathy in Alzheimer’s disease. This comes as Praxis was awarded a $2.9 Million Fast-Track SBIR Grant to advance the company’s lead development candidate, PRX-P4-003….With the positive clinical data from the Phase 0 program and funding of the Fast-Track SBIR Grant, Praxis can now advance PRX-P4-003 to early clinical development.”

Financing • Licensing / partnership • Alzheimer's Disease • CNS Disorders

Microdose Pharmacokinetic Study of PRX-P4-003 In Healthy Volunteers (clinicaltrials.gov) - P1; N=8; Active, not recruiting; Sponsor: Praxis Bioresearch, LLC; Recruiting ➔ Active, not recruiting; Trial primary completion date: Jun 2021 ➔ Oct 2021

Clinical • Enrollment closed • Trial primary completion date