Praxis Bioresearch Obtains FDA Clearance On the IND Application for Its Lead Candidate PRX-P4-003 In Alzheimer’s Disease Apathy

LOS ANGELES, Oct. 29, 2024 (GLOBE NEWSWIRE) — 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. Previously, an exploratory microdose clinical trial in healthy volunteers demonstrated successful activation of PRX-P4-003 upon oral administration, the intended therapeutic route.

“Apathy remains one of the most frequently observed symptoms in the Alzheimer’s Disease with no FDA-approved therapy,” stated Jeffrey Cummings, MD, ScD, director of the Chambers-Grundy Center for Transformative Neuroscience and Professor of Brain Sciences at the University of Nevada Las Vegas, “PRX-P4-003 has chemical properties and preliminary clinical validation that support its potential to build upon the pioneering studies in treating apathy led by the NIH-funded ADMET group.”

PRX-P4-003, a selectively bioavailable dopamine and norepinephrine reuptake inhibitor, is a new chemical entity discovered by Praxis Bioresearch.  The compound was designed to be activated by pancreatic lipase, an enzyme that is only present in the digestive system.

“This is an important milestone for us,” said Sandeep Patil, MD PhD, CEO/Cofounder of Praxis Bioresearch, “I am particularly proud of our team in successfully delivering a high-quality IND package. In the next phase of development, we are deeply committed to demonstrating the effectiveness of our compound in improving the symptoms of apathy in the clinical trials.” 

About PRX-P4-003

PRX-P4-003 is a new chemical entity developed by Praxis Bioresearch that delivers an active isomer of fencamfamine. Fencamfamine is a Schedule IV stimulant that was originally developed and marketed by E. Merck KG, located in Darmstadt, Germany. This prodrug, unlike current stimulants such as methylphenidate and amphetamines, is designed to only be orally active potentially decreasing the risk of abuse. There is a medical need for alternatives to current Schedule II stimulant medications in neuropsychiatric indications as diversion is a significant concern.

About Apathy in Alzheimer’s Disease

Apathy is the most prevalent neuropsychiatric symptom of Alzheimer’s dementia, affecting nearly 71% of patients over the course of the disease. Apathy has been associated with patient suffering, caregiver distress, and excess disability. There is no approved treatment for apathy in Alzheimer’s Disease.

Disclaimer: Research reported in this publication was supported in part by the National Institute of Aging of the National Institutes of Health under Award Number R44AG066378. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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