American biotechnology company Oragenics has entered into a manufacturing agreement with Sterling Pharma Solutions, a leading contract development and manufacturing organization (CDMO), to support the production of ONP-002—its lead drug candidate for the treatment of mild traumatic brain injury (mTBI), commonly known as concussion.

Under the agreement, Sterling will produce ONP-002 under strict current Good Manufacturing Practice (cGMP) conditions at its Cary, North Carolina facility.

The GMP-compliant drug supply will support Oragenics’ planned Phase IIb clinical trials, which are expected to begin next year.

This proof-of-concept study aims to evaluate the early efficacy of ONP-002 in patients with mTBI— a condition that currently has no FDA-approved pharmacological therapies.

 “We are excited to partner with Sterling’s facility in Cary, North Carolina, to support the production of ONP-002,” said Janet Huffman, Chief Executive Officer of Oragenics.

“This partnership is a critical milestone in our path forward for Phase IIb clinical trials.  This partnership reinforces our commitment to quality, efficiency, and U.S.-based innovation and we believe this step will help streamline our clinical development strategy,” she added.

The collaboration is part of Oragenics’ broader strategy to develop scalable, accessible, and fast-acting treatments for neurological trauma, beginning with concussion

“Our scientific expertise in CNS therapies and our ability to meet critical timelines will support the continued path to market for this transformative drug candidate,” said Chad Telgenhof, Chief Commercial Officer at Sterling Pharma Solutions.

Oragenics specialises in the development of intranasal therapeutics targeting neurological disorders. Sterling Pharma Solutions operates six facilities across the UK, Ireland, and the United States—including sites in Cary, North Carolina, and Germantown, Wisconsin— providing small molecule API development and manufacturing services to the pharmaceutical industry.