Enalare Therapeutics Announces Positive Topline Results With ENA001 in a Propofol Induced Respiratory Depression Study
ENA001, an Agnostic Respiratory Stimulant, Successfully Achieved the Study Primary Endpoint and Was Shown to Be Safe and Well Tolerated
PRINCETON, N.J., June 8, 2022 (Newswire.com) - Enalare Therapeutics Inc., a biopharmaceutical company dedicated to developing novel therapies for patients suffering from life-threatening critical care conditions, announced today that it has completed a propofol induced respiratory depression study with its lead compound ENA001, having achieved the targeted primary endpoint. The objective of the study was to demonstrate the ability of ENA001 to reverse respiratory depression induced through administration of propofol, a central nervous system depressant commonly utilized globally as a surgical anesthetic. To date, there is no approved product indicated for the reversal of respiratory depression induced by propofol.
Important Study Results Included:
- Determination of increased ventilatory response (minute ventilation) with dosing of ENA001 under hypoxic and hypercapnic conditions in conjunction with low and high doses of propofol. The hypoxic response was assessed by calculation of the Hypoxic Ventilatory Sensitivity.
- No serious adverse events were experienced during dosing with ENA001
- No clinically relevant changes in cardiovascular parameters were observed during dosing with ENA001
- The study results enable further elucidation of the PK/PD profile of ENA001
"We are very pleased to have completed this important study for ENA001, further demonstrating the safety and efficacy of the compound," stated Joseph Pergolizzi MD, Chief Research and Development Officer of Enalare. "We believe ENA001 has the potential to significantly improve the standard of care for many patients experiencing life-threatening respiratory depression, including those due to drug overdose, post-operative conditions, and apnea of prematurity. We believe the results of this study further highlight the profile of ENA001 as a potentially effective and safe agnostic respiratory stimulant and provide valuable information for the product's clinical program moving forward."
"I congratulate our team and esteemed scientific partners for the successful completion of this important study," stated Herm Cukier, President and CEO of Enalare Therapeutics. "We believe these positive topline results align with the experience from our previous four phase I studies, including having demonstrated the ability of ENA001 to reverse the respiratory depressive effects of a potent opioid and position the Company to further advance the clinical development of ENA001 in the near term."
Enalare's lead compound, ENA001, is a one-of-a-kind new chemical entity designed as an agnostic respiratory stimulant. The compound has a unique mechanism of action that affects ventilation via the peripheral chemoreceptorpathways 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 four previous human studies. ENA001 is an investigational compound and not approved for use by the FDA.
About the Clinical Study
The study was conducted under the direction of Dr. Albert Dahan, a renowned leader in the field of breathing control mechanisms, at the Leiden University Medical Center, the Netherlands. 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 theanalgesic effects of propofol.
About Enalare Therapeutics Inc.
Enalare Therapeutics Inc. is a clinical-stage biopharmaceutical company dedicated to developing novel therapies for patients suffering from life-threatening acute respiratory and critical care conditions, including drug overdose, post-surgery respiratory depression, and apnea of prematurity. The Company is planning to initiate additional clinical studies for ENA001 across multiple indications in the coming year.
Enalare Investor Relations