Enalare Therapeutics Receives Additional Funding From BARDA to Further Advance the Development of Agnostic Respiratory Stimulant (ENA-001)

PRINCETON, N.J., September 10, 2024 (Newswire.com) - 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 it has received additional funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, to further advance the development of its lead compound, ENA-001. The supplementary funding of $4.97 million to the existing BARDA contract will be used to execute preclinical studies requested by the FDA in advance of Enalare proceeding forward with its intended phase 2 clinical study of ENA-001 for use in the hospital setting. This supplemental funding expands the 2022 contract, which now could provide up to $55.8 million to support the development of ENA-001.

“We are very excited to announce this additional funding provided by BARDA and are grateful for their continued partnership and support of the development of ENA-001,” 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 (PORD) and community drug overdose, and as a potential medical countermeasure in the case of a mass-casualty event. We look forward to further strengthening our partnership with BARDA as we proceed forward with the development of ENA-001."

This project has been funded in whole or in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services under contract 75A0122C00072.

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.

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Source: Enalare Therapeutics Inc.