- Oragenics has entered a manufacturing agreement with Sterling Pharma Solutions for GMP production of its concussion therapy candidate, ONP-002.
- The partnership supports Oragenics’ planned Phase IIb clinical trial, scheduled to begin next year.
Oragenics, Inc., a biotechnology company focused on intranasal therapeutics for brain-related conditions, has announced a manufacturing agreement with Sterling Pharma Solutions, a CDMO with multiple development and manufacturing sites in the U.S.
The agreement covers the Good Manufacturing Practice (GMP)-compliant production of Oragenics’ lead drug candidate, ONP-002, which is being developed for the treatment of concussion. The drug will be manufactured at Sterling’s Cary, North Carolina facility in preparation for Oragenics’ planned Phase IIb clinical trials expected to begin next year.
This collaboration marks a step forward in Oragenics’ strategy to build a domestic manufacturing base to support clinical and regulatory progress. “This partnership is a critical milestone in our path forward for Phase IIb clinical trials,” said Janet Huffman, Chief Executive Officer of Oragenics.
Sterling Pharma Solutions will manufacture ONP-002 under cGMP conditions for use in a proof-of-concept study targeting patients with mild traumatic brain injury (mTBI). According to Sterling’s Chief Commercial Officer, Chad Telgenhof, the company’s CNS expertise and ability to meet key deadlines will help drive the development of this potential therapy.
The manufacturing partnership aligns with Oragenics’ broader ambition to create scalable and rapid-acting treatments for neurological trauma, starting with concussion—an area currently lacking FDA-approved pharmacological options.
