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Enalare Therapeutics Receives FDA Clearance for Phase 1 Study of ENA-001 in the US

• Enalare Therapeutics received FDA clearance to begin a Phase 1 clinical trial of ENA-001 in the United States, targeting respiratory depression associated with drug overdose. • The Phase 1 study will evaluate both intramuscular (IM) and intravenous (IV) formulations of ENA-001, building on five previous successful Phase 1 studies in Europe using the IV formulation. • ENA-001's novel mechanism of action as an agnostic respiratory stimulant, inhibiting Big Potassium (BK) ion channels, offers a potential treatment for various life-threatening conditions. • The development of ENA-001 is supported by funding from BARDA and NIDA, highlighting its potential as a medical countermeasure in mass-casualty events and for treating drug overdose.

Enalare Therapeutics Inc. has received FDA clearance to initiate a Phase 1 clinical study of ENA-001 in the United States. The study will investigate the drug's potential to stimulate ventilation in respiratory depression linked to drug overdose.
The Phase 1 trial will assess both an intramuscular (IM) formulation, developed with funding from the Biomedical Advanced Research and Development Authority (BARDA), and an intravenous (IV) formulation administered via bolus injection. This clearance follows demonstrated efficacy and safety in preclinical studies and five completed Phase 1 studies in Europe using the IV formulation.

Novel Mechanism of Action

ENA-001 is a new chemical entity designed as an agnostic respiratory stimulant. It acts via the peripheral chemoreceptor pathways in the carotid body, influencing breathing by inhibiting Big Potassium (BK) ion channels. This mechanism allows it to stimulate breathing regardless of the cause of respiratory depression.
"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," said Joe Pergolizzi, MD, Chief R&D Officer of Enalare Therapeutics.

Potential Applications and Support

Enalare is also exploring ENA-001 for post-operative respiratory depression and apnea of prematurity. The development of ENA-001 is supported by the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH).
"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," stated Bob Raffa, Ph.D., co-founder and Head of Preclinical Development of Enalare Therapeutics.
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Reference News

[1]
Enalare Receives FDA Clearance to Initiate the First Phase 1 Clinical Study of ENA-001 to ...
biospace.com · Sep 25, 2024

Enalare Therapeutics received FDA clearance for a phase I study of ENA-001, a novel respiratory stimulant for treating r...

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