CROWN POINT, Ind. — OYE Therapeutics Inc ., a clinical-stage biopharmaceutical company developing therapies for perioperative and acute care medicine, today (July 14) announced successful top-line results from its Phase 1 clinical study of OYE-101, its proprietary intravenous caffeine formulation.
The randomized, placebo-controlled study evaluated the safety, tolerability and pharmacokinetic profile of OYE-101 in healthy adult volunteers. The Phase 1 data support the scientific bridge underlying the company’s planned 505(b)(2) development pathway.
OYE Therapeutics plans to advance OYE-101 into the next stage of clinical development as it pursues regulatory approval for patients undergoing procedures requiring general anesthesia and deep sedation.
“These Phase 1 results represent an important milestone in the continued development of OYE-101 and establish the scientific foundation supporting our planned 505(b)(2) regulatory pathway,” said Brett Dines, Chief Executive Officer of OYE Therapeutics.
“The successful completion of this study reflects the coordinated efforts of our formulation, manufacturing, regulatory and clinical teams,” said Michael Hicks, MBA, FACHE, Chief Operating Officer of OYE Therapeutics. “Completing Phase 1 positions OYE-101 to move confidently into the next stage of clinical development and represents another important step toward addressing an unmet need in perioperative care.”
OYE operates from the Purdue Technology Center in the Purdue Research Park of Northwest Indiana .
About OYE-101
OYE-101 is a proprietary intravenous caffeine formulation being developed to support emergence from general anesthesia and deep sedation. OYE Therapeutics is pursuing development through the Federal Drug Administration’s 505(b)(2) regulatory pathway.
About OYE Therapeutics
OYE Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapies intended to improve patient recovery and outcomes in perioperative and acute care settings.
Media/investor contact: Mike Hicks, OYE Therapeutics Inc., Chief Operating Officer, 219-281-2369, mhicks@oyetherapeutics.com
Randomized controlled/clinical trial
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