Ontario Sun - Oragenics Inc. Secures U.S. Manufacturing Partner for Concussion Drug Ahead of Phase IIb Trials

Oragenics Inc. (NYSE American: OGEN), a biotechnology firm specializing in intranasal therapeutics for brain-related conditions, has announced a manufacturing agreement with Sterling Pharma Solutions. This partnership is for the Good Manufacturing Practice (GMP) production of ONP-002, Oragenics’ lead drug candidate aimed at treating concussions. The production will take place at Sterling’s facility in Cary, North Carolina, under current Good Manufacturing Practice (cGMP) conditions, in preparation for the anticipated Phase IIb trials set to commence next year.

This collaboration represents a pivotal advancement for Oragenics, as it ensures a streamlined process for clinical development and regulatory approvals by securing a U.S.-based manufacturing partner. Janet Huffman, CEO of Oragenics, emphasized the significance of this partnership, describing it as a critical milestone that highlights the company’s dedication to innovation and quality within the United States.

The agreement with Sterling Pharma Solutions not only facilitates the production of ONP-002 but also reinforces Oragenics’ commitment to addressing the challenges associated with mild traumatic brain injury (mTBI), commonly known as concussion. By advancing the development of ONP-002, Oragenics is taking a significant step forward in the potential treatment of concussions, a condition that affects millions worldwide and currently lacks a definitive pharmaceutical treatment.

For further details on Oragenics and its initiatives, interested parties can visit the company’s website at https://www.Oragenics.com. Additional news and updates regarding OGEN are available in the company’s newsroom at https://ibn.fm/OGEN.