Funding from the NIH's National Institute on Drug Abuse (NIDA) will Support Development of ENA-001, an Agnostic Respiratory Stimulant, for Community Drug Overdose and as a Medical Countermeasure
PRINCETON, NEW JERSEY / ACCESS Newswire / January 30, 2025 / Enalare Therapeutics Inc., a biopharmaceutical company dedicated to developing novel therapies for patients suffering from life threatening critical care conditions and national health emergencies, announced today that it has been awarded the second component of a grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH). Funding from the grant of approximately $2.5 million will be used to execute ENA-001 Study 109, the sixth Phase 1 study for Enalare's novel compound, supporting development of medication for the treatment of respiratory depression due to opioid (prescribed or illicit) overdose/multidrug (polysubstance) overdose in a hospital or community setting. The study will consist of utilizing both Enalare's new intramuscular (IM) formulation, 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 (IV) formulation via a bolus injection.
"We are very grateful for the funding support from NIDA to pursue development of ENA-001 as a potential new treatment for community drug overdose and as a medical countermeasure in case of a mass-casualty event," stated Tom Miller PhD, Senior Vice President and Head of Clinical Development of Enalare. "The drug overdose epidemic continues to ravage communities across the United States and is growing in complexity, as is the threat by nefarious actors of using narcotics and other agents against the civilian population. 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 in the community."
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.
Research into 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 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 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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Contact Information
Morgan Wagner
Investor Relations
mwagner@enalare.com
SOURCE: Enalare Therapeutics
