Praxis Bioresearch Awarded $2.9 Million Fast-Track SBIR Grant for Development of Novel Therapy for Apathy in Alzheimer’s Disease

National Institutes of Health Funding to Support Ongoing Advancement of Innovative Treatments in Preventing and Treating Alzheimer’s Disease and Alzheimer’s Disease-Related Dementias

LOS ANGELES, Aug. 05, 2021 (GLOBE NEWSWIRE) — Praxis is proud to announce to be the recipient of a Fast-Track SBIR award to develop treatment for apathy in Alzheimer’s Disease. The award, in its second of three years and expected to total $2.9 million, will support the IND-enabling work to advance the Company’s lead candidate, PRX-P4-003, a novel dopaminergic stimulant prodrug for the treatment of apathy in AD.

Apathy is the most prevalent neuropsychiatric symptom of dementia,” said Jacobo Mintzer, MD, MBA, Director, South Carolina Institute for Brain Health, and Study Chair for Apathy in Dementia Methylphenidate Trials. “It affects 71% of patients suffering from dementia 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 dementia today. I am delighted to see this prestigious award providing evidence of the of collaboration between bio-pharmaceutical companies and the National Institutes of Health in the development of new treatments for these devastating symptoms of dementia.

PRX-P4-003 is a new chemical entity (US Patent 10,662,146) designed by Praxis to be an abuse resistant, once-a-day medicine to treat apathy caused by Alzheimer’s disease as well as other diseases requiring dopaminergic stimulant activity. Specifically, the objective of the molecular design of PRX-P4-003 was to deliver the active isomer of fencamfamine but restrict the delivery of its stimulant activity to only the oral route of administration thus differentiating it from other FDA-approved stimulants. The molecule serves as a substrate of pancreatic lipase, an enzyme whose biological activity is almost entirely restricted to the gut. Praxis recently reported successful conversion of orally administered PRX-P4-003 to the active isomer of fencamfamine in healthy volunteers (ClinicalTrials.gov Identifier: NCT04638803).

According to Bill Potter MD PhD, Principal Investigator of the grant award and widely respected neuroscience expert,With evidence in place that the prodrug has the desired special properties in humans, what makes this grant award especially notable is that it supports critical components of developing a compound with an unusually high probability of meeting regulatory requirements and addressing a critically important clinical need. I am optimistic that the current project will provide a case for this funding model to be expanded.

Praxis Bioresearch, a clinical stage biopharmaceutical company is focused on the discovery and development of novel therapeutics for chronic central nervous system disorders.

“We are honored to receive this highly competitive SBIR award from National Institute of Aging as we work continuously to build upon the pioneering findings on treating apathy by the ADMET group. The funding will support advancement of PRX-P4-003 to early clinical development,” said Sandeep Patil, PhD, MD, chief executive officer of Praxis Bioresearch.

About PRX-P4-003

PRX-P4-003 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. 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: The SBIR Grant is supported by the National Institute on 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.

Contact:
Rudi Ross
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