Enalare Therapeutics Inc., a biopharmaceutical company, announced that the US Food and Drug Administration (FDA) has granted its lead compound, ENA-001, Orphan Drug Designation for the treatment of apnea of prematurity (AoP).
WOODCLIFF LAKE, N.J. and PRINCETON, N.J., Oct. 03, 2022 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) and Enalare Therapeutics Inc. (“Enalare”) today announced that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation (“ODD”) to ENA-001 for the treatment of Apnea of Prematurity (“AoP”), a new chemical entity with a novel mechanism of action as a respiratory stimulant. AoP is a development disorder attributed to immaturity of the pulmonary system characterized by either cessation of breathing for more than 20 seconds or cessation of breathing that lasts less than 20 seconds but is accompanied by either bradycardia or hypoxemia. The condition affects approximately 25% of all preterm infants.1
Eagle Pharmaceuticals is keeping an eye on Enalare Therapeutics’ lead respiratory candidate, and apparently, so is the US government.
-- ENA-001 is currently in development for: post-operative respiratory depression, community drug overdose, and Apnea of Prematurity --
Enalar Therapeutics Inc. will use the funds to advance ENA001, their investigational product for patients that experience respiratory depression from either overdose or multidrug (polysubstance) overdose. The underlying intellectual property of ENA001 goes back to over a decade when a biotech venture called Galleon Pharmaceuticals first developed the compound called GAL-021. This biotech filed bankruptcy in 2016, and by 2019 Enalare acquired the assets of the former biotech.