Oragenics Inc. Secures U.S. Manufacturing Partner for Concussion Drug Ahead of Phase IIb Trials
July 16th, 2025 2:10 PM
By: Newsworthy Staff
Oragenics Inc. has partnered with Sterling Pharma Solutions for the GMP production of its concussion drug candidate, ONP-002, marking a significant step towards Phase IIb trials and underscoring the importance of domestic manufacturing in clinical development.
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 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, to support the upcoming Phase IIb trials scheduled 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, through innovative nasal delivery solutions. For more details on the partnership and the upcoming trials, visit https://ibn.fm/QfLqI.
Source Statement
This news article relied primarily on a press release disributed by InvestorBrandNetwork (IBN). You can read the source press release here,
