Enalare Receives FDA Clearance to Initiate the First Phase 1 Clinical Study of ENA-001 to Be Conducted in the United States

PRINCETON, NJ / ACCESSWIRE / September 24, 2024 / Enalare Therapeutics Inc., a clinical-stage biopharmaceutical company dedicated to developing novel compounds for the treatment of life-threatening critical care conditions and community health emergencies, today announced that is has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a phase I clinical study of ENA-001 that supports the proposed indication for stimulation of ventilation in respiratory depression associated with drug overdose. The study will consist of utilizing both Enalare's new Intramuscular formulation (IM), developed with funding provided by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services, as well as an intravenous formulation (IV) via a bolus injection. The FDA provided Enalare the clearance to proceed into human clinical development based on the demonstrated evidence of ENA-001's efficacy and safety across a multitude of preclinical studies. There have been five phase 1 studies successfully completed in Europe with ENA-001 utilizing an intravenous (IV) formulation.

"We are very excited to proceed forward with the first human study in the United States with ENA-001 and thank the FDA Division, and its team members, for the close collaboration along the journey to reach this important milestone," stated Joe Pergolizzi, MD, Chief R&D Officer of Enalare Therapeutics. "We believe ENA-001, with its novel mechanism of action as an agnostic respiratory stimulant, has the potential to improve the lives of those impacted by several life-threatening conditions, including post-operative respiratory depression and community drug overdose, and as a potential medical countermeasure in the case of a mass-casualty event. We look forward to continuing to work closely with the FDA, and our partners at BARDA and the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH), as we proceed forward with the development of ENA-001."

"This is an important milestone in the development of ENA-001," stated Bob Raffa, Ph.D., co-founder and Head of Preclinical Development of Enalare Therapeutics. "We believe that ENA-001's differentiated approach to stimulating breathing by inhibiting Big Potassium (BK) ion channels in the carotid bodies, thus stimulating breathing across multiple etiologies of respiratory depression, regardless of its causality, offers the promise of becoming an important treatment option for patients experiencing a multitude of life-threatening conditions."

This project has been funded in whole or in part with federal funds from the Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority, under contract number 75A50122C00072.

The development of ENA-001 is also supported by the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH) under award number R44DA057133. The content of this document is the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About Enalare Therapeutics Inc.

Enalare Therapeutics Inc. is a clinical-stage biopharmaceutical company dedicated to developing novel therapies for patients suffering from life-threatening critical care conditions and community-based health emergencies, including post-operative respiratory depression, community drug overdose, and apnea of prematurity. Enalare plans to initiate additional clinical studies for ENA-001 across multiple indications in the near term.

About ENA-001

Enalare's lead compound, ENA-001, is a one-of-a-kind new chemical entity (NCE) designed as an agnostic respiratory stimulant. The compound has a novel mechanism of action that affects ventilation via the peripheral chemoreceptor pathways in the carotid body. It utilizes the body's own ventilation control system to beneficially influence breathing and has been shown to be effective and well-tolerated in five human studies to date. With its novel mechanism of action and findings to date, it could potentially improve the lives of those impacted by several life-threatening conditions, including community drug overdose, post-operative respiratory depression, and apnea of prematurity. ENA-001 is an investigational compound and is not approved for use by the FDA.

Contact Information

Morgan Wagner
Investor Relations
mwagner@enalare.com

SOURCE: Enalare Therapeutics Inc.

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