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 pivotal manufacturing agreement with Sterling Pharma Solutions. This partnership will facilitate 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, adhering to current Good Manufacturing Practice (cGMP) standards, in preparation for the anticipated Phase IIb trials set to commence next year.

This collaboration represents a significant milestone for Oragenics, as it ensures a streamlined pathway for the clinical development and regulatory approval process of ONP-002 by securing domestic manufacturing capabilities. Janet Huffman, CEO of Oragenics, emphasized the importance of this partnership, describing it as a critical milestone that highlights the company's dedication to fostering innovation and maintaining high-quality standards within the United States.

The advancement of ONP-002 into Phase IIb trials is a crucial step forward in addressing the unmet medical needs associated with mild traumatic brain injury (mTBI), commonly known as concussion. The partnership with Sterling Pharma Solutions not only accelerates Oragenics' clinical development timeline but also reinforces the potential of ONP-002 to make a meaningful impact on patients suffering from concussion-related conditions.

For further details on Oragenics Inc. and its innovative approaches to treating brain-related conditions, visit https://www.Oragenics.com. Additional information and updates regarding OGEN can be found in the company's newsroom at https://ibn.fm/OGEN.