Oragenics Inc. (NYSE American: OGEN), a biotechnology firm specializing in intranasal therapeutics for brain-related conditions, has entered into a manufacturing agreement with Sterling Pharma Solutions. This partnership is set to 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, under current Good Manufacturing Practice (cGMP) conditions, in preparation for the anticipated Phase IIb trials next year.
This collaboration represents a pivotal advancement for Oragenics, as it ensures a streamlined process for clinical development and regulatory approvals within the United States. 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 in the U.S. biotech industry.
The development of ONP-002 is particularly noteworthy given the growing concern over concussions and their long-term effects on individuals. By advancing this drug into Phase IIb trials, Oragenics is contributing to the potential expansion of treatment options for mild traumatic brain injury (mTBI), offering hope to millions affected by such conditions annually.
For further details on the press release, visit https://ibn.fm/QfLqI.
