Antley-Bixler Syndrome Phenotype

PRINCETON, N.J., September 10, 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 it has received additional funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, to further advance the development of its lead compound, ENA-001. The supplementary funding of $4.97 million to the existing BARDA contract will be used to execute preclinical studies requested by the FDA in advance of Enalare proceeding forward with its intended phase 2 clinical study of ENA-001 for use in the hospital setting. This supplemental funding expands the 2022 contract, which now could provide up to $55.8 million to support the development of ENA-001. “We are very excited to announce this additional funding provided by BARDA and are grateful for their continued partnership and support of the development of ENA-001,” stated Joe Pergolizzi, MD, Chief R&D Officer of Enalare Therapeutics. “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 (PORD) and community drug overdose, and as a potential medical countermeasure in the case of a mass-casualty event. We look forward to further strengthening our partnership with BARDA as we proceed forward with the development of ENA-001." This project has been funded in whole or in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services under contract 75A0122C00072. 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. ### Source: Enalare Therapeutics Inc. BARDA Enalare Therapeutics Respiratory Depression Morgan Wagner Investor Relations mwagner@enalare.com Enalare Therapeutics is Granted a New Patent for ENA-001, Extending Its Exclusivity in the U.S. to 2043 6 days ago The New Patent Covers ENA-001 Methods of Treating Respiratory Depression Caused by Propofol, a Widely Used, Centrally Acting Anesthetic Enalare Receives FDA Clearance to Initiate the First Phase 1 Clinical Study of ENA-001 to Be Conducted in the United States 1 month ago Enalare Therapeutics Announces Publication of a Clinical Study Demonstrating the Effect of ENA-001 on Improving Propofol-Induced Depression of the Hypoxic Ventilatory Response 9 months ago

PRINCETON, NJ / ACCESSWIRE / February 15, 2024 / 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 the publication of a respiratory depression study with its lead compound, ENA-001 in the journal Anesthesiology. The article entitled "Reversal of Propofol-induced Depression of the Hypoxic Ventilatory Response by BK-channel Blocker ENA-001: A Randomized Controlled Trial" is based on a clinical study conducted under the direction of Albert Dahan, MD, PhD, a renowned global leader in the field of breathing control mechanisms, at the Leiden University Medical Center, the Netherlands. "We are excited to have the results of this breakthrough clinical study published in such a prestigious journal as Anesthesiology," stated Joseph Pergolizzi, MD, Chief Research and Development Officer of Enalare. "The results of this successful clinical study further elucidate the ability of ENA-001 to serve as an agnostic respiratory stimulant and improve ventilatory capacity in patients experiencing acute respiratory depression, regardless of the underlying cause." The objective of the study was to demonstrate the ability of ENA-001 to reverse respiratory depression induced through administration of propofol, a central nervous system depressant commonly utilized globally as a surgical anesthetic. Dosing regimens were explored to observe the restoration of ventilatory sufficiency under normal sedation, show increased ventilatory responsiveness to hypoxemic events and avert ventilatory degradation during periods of clamped hypercapnia, all while preserving the anesthetic effects of propofol. "I believe the positive results of this clinical study are potentially an important advancement for patients suffering from acute respiratory depression, including post-operatively," stated Dr. Dahan. "In my own clinical experience, as well as in the growing body of published literature, there is a growing recognition of the incidence of Post-Operative Respiratory Depression (PORD) and its negative impact on surgical patient recovery. New modalities, such as an agnostic respiratory stimulant, are needed to improve the standard of care for these patients." Important study results, with potential clinical patient benefits, include demonstrating the following: That ENA-001 is able to restore the propofol-impaired hypoxic ventilatory response (HVR), potentially increasing patient safety from a blunted HVR. That the peripheral stimulation of breathing with ENA-001 overcomes central depression by propofol without any signs of a ceiling limitation. That ENA-001 is able to reverse non-opioid (propofol)-induced respiratory depression as well as the previously demonstrated ability to reverse opioid-induced respiratory depression. This result further exemplifies the ability of ENA-001 to function as an agnostic respiratory stimulant. 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. Contact Information: Morgan Wagner Investor Relations mwagner@enalare.com SOURCE: Enalare Therapeutics Inc. View the original press release on newswire.com.