Major clinical milestone advances novel intravenous caffeine formulation designed to accelerate emergence from general anesthesia and shorten postoperative recovery
CROWN POINT, Ind. – OYE Therapeutics Inc., a clinical-stage biotechnology company developing therapies for perioperative and emergency medicine, announced that the first patient has been dosed in its Phase 2 clinical trial evaluating OYE-101.
The investigational intravenous caffeine formulation is designed to accelerate emergence from general anesthesia.
The milestone represents a significant advancement in OYE’s clinical development program, following completion of its Phase 1 scientific bridging study. That study demonstrated favorable safety and tolerability and generated pharmacokinetic data supporting continued clinical development.
OYE intends for the Phase 2 trial to serve as a pivotal efficacy study in support of its planned New Drug Application. It will evaluate the efficacy and safety of OYE-101 in adult surgical patients, including its ability to accelerate emergence from general anesthesia and improve postoperative recovery.
“Initiating our Phase 2 clinical trial represents an important milestone for OYE Therapeutics and brings us closer to addressing a significant unmet need in perioperative medicine,” said Brett Dines, CEO of OYE Therapeutics. “We believe our novel intravenous caffeine formulation has the potential to meaningfully improve recovery from anesthesia, benefiting patients, clinicians and healthcare systems.”
General anesthesia and deep sedation are used in millions of surgical and procedural cases annually. Delayed emergence, residual sedation and associated respiratory complications can prolong recovery, increase healthcare resource utilization and contribute to postoperative care challenges.
The Phase 2 trial is expected to enroll approximately 40 adult surgical patients and will evaluate time to emergence, sedation and alertness, and postoperative recovery readiness.
The OYE-101 clinical development program is being conducted under an active Investigational New Drug application with the U.S. Food and Drug Administration (FDA). OYE is pursuing the FDA’s 505(b)(2) regulatory pathway, which permits reliance, where appropriate, on existing findings concerning previously approved drugs, supplemented by clinical data supporting the safety and efficacy of OYE-101 for its proposed indication.
OYE Therapeutics operates from the Purdue Technology Center in the Purdue Research Park of Northwest Indiana.
About OYE Therapeutics
OYE Therapeutics Inc. is a clinical-stage biotechnology company focused on developing therapies that improve outcomes in surgical, emergency and acute-care medicine. The company’s lead program, OYE-101, is a novel intravenous caffeine formulation designed to accelerate recovery from anesthesia and deep sedation and to address related respiratory complications. OYE Therapeutics is headquartered at the Purdue Technology Center in Crown Point, Indiana.
For more information, visit www.oyetherapeutics.com.
Forward-looking statements
This announcement contains forward-looking statements regarding the clinical development of OYE-101, including the anticipated conduct and objectives of the Phase 2 trial, its potential role in supporting a future New Drug Application, and the potential benefits of OYE-101. Actual results may differ from current expectations due to risks and uncertainties associated with clinical trial outcomes, regulatory review, and drug development.
Media Contact
Michael Hicks, MBA, FACHE
Chief Operating Officer
OYE Therapeutics Inc.
mhicks@oyetherapeutics.com
219-281-2369
