Enalare Therapeutics Receives an Additional Award Worth Up to $50 Million From BARDA, Expanding Its Partnership in Development of ENA-001

The Funding Will Accelerate Development of an Intramuscular Formulation of ENA-001, a Novel Agnostic Respiratory Stimulant, for the Potential Treatment of Community Drug Overdose and as a Medical Countermeasure for Mass Casualty Events. The Funding Supports Development of an Intramuscular ENA-001 From Pre-Clinical Toxicology Through Filing for Approval in the United States

Enalare Therapeutics Inc., a clinical stage biopharmaceutical company dedicated to developing novel compounds for the treatment of life-threatening critical care diseases and community medical threats, announced today that it has received a contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response in the U.S. Department of Health and Human Services, of up to $50.3 million to support development of the company's lead compound ENA-001.

The award, stage-gated based on achievement of pre-determined milestones and deliverables, provides funding for Enalare to perform pre-clinical toxicology, human clinical studies, drug and device manufacturing, and regulatory file submission for a formulation of ENA-001 suitable for community use. ENA-001, a New Chemical Entity (NCE) with a novel mechanism of action, has broad applications as an agnostic respiratory stimulant. The first phase of the contract, which provides approximately $6 million to complete activities through the initial phase 1 study, coincides with grant support from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health.

The new award builds on an existing partnership between Enalare Therapeutics and the BARDA DRIVe ReDIRECT (Repurposing Drugs in Response to Chemical Threats) program. During that project, Enalare Therapeutics performed work to develop a formulation of ENA-001 that is suitable for intramuscular administration, which is much preferred for emergency use in the community.

"We are excited to expand our partnership with BARDA in the development of rapidly deployable intramuscular formulation of ENA-001 for the emergency treatment of substance-induced respiratory depression," stated Daniel Motto, Chief Operating Officer of Enalare Therapeutics. "We appreciate BARDA's recognition of the need for new innovative treatment options and look forward to continuing our collective efforts as the threats to American civilians continue to escalate in these arenas."

"Receiving this expanded BARDA funding is another important step in 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 bodies 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 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 medical threats. The company is developing products with an initial focus in post-operative respiratory depression, community drug overdose and apnea of prematurity. Enalare maintains global rights to its novel compounds and intends to start additional clinical trials with ENA-001 for several indications in the near term.

About ENA-001

Enalare Therapeutics' 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. ENA-001 is an investigational compound and is not approved for use by the FDA.


Source: Enalare Therapeutics Inc.