Oragenics Inc. Announces Manufacturing Agreement for Concussion Treatment Drug

Oragenics Inc. (NYSE American: OGEN), a leader in the development of intranasal therapeutics for brain-related conditions, has entered into a manufacturing agreement with Sterling Pharma Solutions for its promising drug candidate, ONP-002. This drug is designed to treat concussions, a form of mild traumatic brain injury (mTBI), through innovative nasal delivery systems. The agreement ensures that ONP-002 will be produced under current Good Manufacturing Practice (cGMP) conditions at Sterling Pharma Solutions' facility in Cary, North Carolina, in preparation for Phase IIb clinical trials set to begin next year.

This partnership is a strategic move for Oragenics, as it secures a U.S.-based manufacturing partner, facilitating a smoother path through clinical development and regulatory approvals. Janet Huffman, CEO of Oragenics, highlighted the significance of this collaboration, noting it as a critical milestone that reflects the company's commitment to innovation and quality in the biotechnology sector. The development of ONP-002 is part of Oragenics' focused efforts to address the unmet medical needs of patients suffering from mTBI, leveraging its expertise in neurology and infectious diseases.

The implications of this announcement are far-reaching, as it not only advances Oragenics' position in the biotechnology field but also offers hope for improved treatment options for concussion patients. The collaboration with Sterling Pharma Solutions underscores the importance of strategic partnerships in accelerating the development of innovative therapies. With the upcoming Phase IIb trials, the medical community eagerly anticipates the potential benefits ONP-002 could bring to individuals affected by concussions, further solidifying Oragenics' role in pioneering treatments for brain-related conditions.