Oragenics and Sterling Announce Manufacturing Partnership

Oragenics, Inc., a biotechnology company developing intranasal therapeutics for brain-related conditions, today announced it has entered into a manufacturing agreement with Sterling Pharma Solutions for the production of ONP-002, its lead intranasal drug candidate for the treatment of concussion.

The agreement involves the GMP manufacture of drug substance supply ahead of the planned Phase IIb clinical trials planned to start next year. The collaboration marks an important milestone for Oragenics as it secures domestic production capabilities to support its upcoming clinical and regulatory efforts.

“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.”

Sterling will produce ONP-002 under strict cGMP conditions for use in Oragenics’ planned Phase IIb trials, a proof of concept study which will evaluate early efficacy of ONP-002 in patients with mild traumatic brain injury (mTBI).

Chad Telgenhof, Chief Commercial Officer at Sterling Pharma Solutions, said: “We are pleased to be partnering with Oragenics for the GMP production of its lead molecule for clinical trials. 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.”

This U.S.-based manufacturing agreement builds upon Oragenics’ broader strategy to develop scalable, accessible, and fast-acting treatments for neurological trauma, beginning with concussion, a condition that currently has no FDA-approved pharmacological therapies.