Oragenics, Inc. Provides Update on its Drug Intended to Treat Concussion and Non-Compliance with NYSE American Continued Listing Standards

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Oragenics
Oragenics

SARASOTA, Fla., Aug. 16, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN) ("the Company"), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced recent and key 2024 business progress. The Company continues to execute its business strategy to develop and advance its lead candidate, ONP-002, for the treatment of concussion. Phase 2 human trials are being planned with anticipation of starting in the fourth quarter of this year.

Achievements:

  • Stability of ONP-002 Across a Wide Temperature Range: Demonstrated that ONP-002 is stable at high and low temperatures, eliminating the need for cumbersome cold storage. This stability is critical for field delivery in diverse environments, including for military training and contact sports that are often conducted in extreme temperatures.

  • Phase 2 Clinical Trial Preparation: The Company made significant strides in preparing for a Phase 2 clinical trial regarding ONP-002, a new chemical entity (NCE) designed to target the brain through delivery into the nasal cavity and onward to the brain. In May, the company partnered with Avance Clinical to conduct the upcoming trial in Australia. Phase 1 data has been reviewed and accepted establishing that ONP-002 is safe to move into a Phase 2 trial to further evaluate safety and efficacy. Clinical sites are being identified and educated on the patient enrollment process. The spray dry drug formulation and filling of devices for use in Phase 2 clinical trials is near completion.

  • Improvements in Drug Formulation: Improved the intranasal drug formulation, increasing the amount of ONP-002 per dose by 4X, thereby increasing the amount of drug that the brain will be exposed to with a single treatment.

  • Development of Automated Intranasal Device: Completed the prototype for an automated intranasal device designed for use in concussed patients who are initially dazed, confused, or unconscious, facilitating drug administration during the acute phase of injury.

  • Successful Completion of FDA-Required Testing: ONP-002 cleared FDA-required cardiotoxicity and genotoxicity testing, confirming the safety of the drug for further clinical development. These results strengthen the safety profile of ONP-002, paving the way for the upcoming Phase 2 trials. These were the final studies required to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). Currently, the IND package is being generated with the support of Syneos Health’s regulatory team and will be the basis for starting a Phase 2b study in the U.S. to evaluate the effects of ONP-002 on clinical outcome measures following concussion.

  • Completed Public Offering: Closed a public offering, raising approximately $1.1 million, to support the continued development of ONP-002 and other corporate needs.

  • Appointed Medical Advisors: Dr. William ‘Frank’ Peacock, a leading expert in emergency medicine and diagnostic biomarkers, was named as Chief Clinical Officer, and Dr. James ‘Jim’ Kelly, a world renown neurologist and key opinion leader in concussion, joined as Chief Medical Officer. These new team members were appointed to oversee the upcoming Phase 2 clinical trial for treating concussion in the emergency department.