CROWN POINT, Ind. — OYE Therapeutics , a clinical-stage biopharmaceutical company advancing novel therapies for perioperative, emergency and acute-care medicine, today (Feb. 2) announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for its OYE-101 (caffeine) injection, authorizing the initiation of clinical development.
Brett Dines, CEO of OYE Therapeutics, said that OYE-101 is a novel intravenous caffeine formulation that reverses the effects of, or accelerates emergence from, general anesthesia and deep sedation in adults.
“It also is being developed for broader respiratory stimulant applications, including the treatment of opioid-induced respiratory depression, such as that associated with fentanyl overdose,” he said.
Dines said that anesthetic and opioid agents are widely used across surgical, procedural and emergency settings.
“But there are currently no FDA-approved pharmacologic agents specifically indicated to actively promote emergence from general anesthesia or to directly reverse opioid-related respiratory depression without impacting the analgesic effects of the opioid,” he said.
Dines said the FDA’s Investigational New Drug clearance for OYE-101 represents a major milestone and validates the progress the company has made in formulation, manufacturing and preclinical development.
“Advancing OYE-101 into the clinic positions us to address critical and underappreciated gaps in both perioperative recovery and emergency respiratory care,” he said.
The cleared Investigational New Drug application supports a Phase 1 randomized, active- and placebo-controlled, single ascending dose clinical trial designed to evaluate the safety, tolerability and comparative pharmacokinetics of OYE-101 in healthy volunteers. Data from the study is anticipated to inform a 505(B)(2) submission for use in surgical, procedural and acute-care settings.
Emergence from general anesthesia and deep sedation can be associated with delayed awakening, residual sedation and emergence delirium in the post-anesthesia care unit, Dines said, contributing to patient risk, prolonged recovery and increased health care costs.
“In parallel, opioid-induced respiratory depression remains a leading cause of morbidity and mortality in overdose and trauma settings, particularly with the increasing prevalence of high-potency synthetic opioids such as fentanyl,” he said. “OYE-101 is intended to support faster, more predictable recovery and respiratory stimulation without compromising analgesia or patient safety.”
In addition to its clinical development efforts, OYE Therapeutics is advancing OYE-101 through a research collaboration with the U.S. Department of War, the Uniformed Services University of the Health Sciences and the Henry M. Jackson Foundation for the Advancement of Military Medicine . The collaboration focuses on evaluating the use of OYE-101 in military and battlefield-relevant medical scenarios. It is being conducted under a sponsored, multi-year $20 million research contract.
“With the FDA notice to proceed, we are focused on disciplined execution,” Dines said. “We believe OYE-101 has the potential to improve recovery profiles, enhance operational efficiency in perioperative care and provide a novel pharmacologic tool for addressing life-threatening respiratory depression.”
OYE Therapeutics plans to proceed with site activation and initiate enrollment in its Phase 1 study, with initial safety and pharmacokinetic data anticipated after completion of dosing.
OYE operates from the Purdue Technology Center in the Purdue Research Park of Northwest Indiana.
About OYE Therapeutics
OYE Therapeutics Inc. is a clinical-stage biopharmaceutical company dedicated to improving surgical, emergency and acute-care medicine through the development of targeted therapies that accelerate recovery from anesthesia, deep sedation and opioid-induced respiratory depression. The company’s lead program, OYE-101, is a novel intravenous caffeine formulation designed to address critical unmet needs across perioperative and emergency care settings. OYE Therapeutics is an innovative drug development company headquartered at the Purdue Technology Center in Crown Point, Indiana.
Media Contact:
Michael Hicks
Chief Operating Officer
mhicks@oyetherapeutics.com
219-281-2369