Enalare Therapeutics is Granted a New Patent for ENA-001, Extending Its Exclusivity in the U.S. to 2043

PRINCETON, N.J., November 14, 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 the U.S. Patent and Trademark Office (USPTO) has granted U.S. Patent No. 12,138,267 on November 12, 2024, titled, “Methods of Treating Respiratory Depression Modulated by a Non-Opioid Agent,” covering methods of treatment for the Company’s novel proprietary agnostic respiratory stimulant product candidate, ENA-001. The granted patent has a term until January 2043 and builds upon the existing catalog of intellectual property for ENA-001, including composition of matter protection.

“We are excited to have been granted this new patent for ENA-001 by the USPTO based on the innovative clinical activity of our scientific team,” stated Joe Pergolizzi, M.D., Chief R&D Officer of Enalare Therapeutics. “Being able to fortify and extend the market exclusivity for a novel new chemical entity (NCE) like ENA-001 with this granted method of use patent helps ensure that we properly develop this one-of-a-kind agnostic respiratory stimulant with the potential to improve the lives of those impacted by several life-threatening conditions, including post-operative respiratory depression and community drug overdose, as well as a potential medical countermeasure in the case of mass-casualty events."

“Being granted this new patent from the USPTO is recognition of ENA-001’s therapeutic potential which is based on its novel and effective mechanism of action,” stated Bob Raffa, Ph.D., Co-Founder and Head of Preclinical Development of Enalare Therapeutics. “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.”

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 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.

Forward-Looking Statement Disclaimer

This press release and any statements of representatives and partners of Enalare Therapeutics Inc. (the “Company”) related thereto contain, or may contain, among other things, certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of the Company's control. The Company's actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

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CONTACT:

Morgan Wagner

Investor and Media Relations

[email protected]

Source: Enalare Therapeutics Inc.