Enalare Therapeutics Announces Partnership With BARDA to Advance Development of Its Lead Product ENA-001

The Funding Will Accelerate Development of an Intramuscular Formulation of a Novel Agnostic Respiratory Stimulant to Treat Life-threatening Respiratory Depression

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Enalare Therapeutics Inc. announced today that it has received an initial contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, to support development of the company's lead product ENA-001. The funding will be used to advance development of an intramuscular (IM) formulation for ENA-001, a New Chemical Entity (NCE) with a novel mechanism of action and potential broad applications as an agnostic respiratory stimulant. The funding is provided via the BARDA Division of Research, Innovation, and Ventures' (DRIVe) Repurposing Drugs in Response to Chemical Threats (ReDIRECT) program, in partnership with the BARDA Chemical Medical Countermeasures (MCMs) Program, to support development of therapeutic candidates as MCMs against a range of chemical threats.

"We thank BARDA for their support of ENA-001 and look forward to advancing the development of this novel product for use as an agnostic respiratory stimulant," stated Herm Cukier, President and CEO of Enalare Therapeutics. "The IM formulation will enable rapid deployment in the community setting, potentially saving lives following exposure to respiratory depressive agents through terrorist attacks, industrial accidents, and other situations including drug overdose."

"Receiving this BARDA funding is an important step in further advancing ENA-001 toward U.S. Food and Drug Administration (FDA) approval," added Joe Pergolizzi, MD, Chief R&D Officer of Enalare Therapeutics. "ENA-001's unique mechanism acting on the peripheral chemoreceptors in the carotid body enables a very rapid and effective ventilatory stimulation, irrespective of what caused the respiratory depression. This is critical for effective post-exposure therapy given the urgency for treatment and the unknowns associated with many chemical threats."

This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response: Biomedical Advanced Research and Development Authority, under Contract No. 75A50121C00044.

About Enalare Therapeutics Inc.

Enalare Therapeutics Inc. is a clinical stage biopharmaceutical company dedicated to developing and commercializing novel therapies for patients suffering from life threatening acute respiratory and critical care conditions including respiratory depression caused by drug overdose, post-surgery, and respiratory infections. The Company is planning to initiate additional studies for its lead compound ENA-001 in the near term.

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Contact:

Morgan Wagner
Investor Relations
mwagner@enalare.com

Source: Enalare Therapeutics Inc.

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Categories: Pharmaceuticals and Biotech

Tags: BARDA, Enalare Therapeutics, Federal Grant, Opioid Crisis, Polyoverdose Crisis


About Enalare Therapeutics

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Enalare Therapeutics Inc. is a clinical stage biopharmaceutical company dedicated to developing and commercializing novel therapies for patients suffering from acute respiratory conditions.

Enalare Therapeutics
868 106TH AVE NORTH
Naples, Fl 34108
United States