Read more about Oragenics Receives HREC Approval for Phase IIa Clinical Trial of ONP-002 as a Treatment for Concussion and Mild Traumatic Brain Injury in Australia.

Oragenics’ CEO Janet Huffman commented, “Through successful operational, regulatory and financial execution over the past year, we achieved key strategic milestones that secured the clinical infrastructure required to enter a Phase 2 clinical trial of ONP-002 in Australia this year. We have demonstrated financial discipline and transparency in support of our clinical development program, and the Company is now well-positioned to advance ONP-002 toward meaningful value-creating milestones.

Read more about Oragenics Targets Projected $9 Billion Market by Advancing First and Only Clinical-Stage Concussion and Mild Traumatic Brain Injury Therapy.

UF Innovate | Accelerate graduate Oragenics, Inc., a clinical-stage biotechnology company pioneering intranasal drug delivery for neurological conditions, announced the selection of Southern Star Research as its Clinical Research Organization (CRO) for the upcoming Phase IIa clinical trial of ONP-002, the company’s lead drug candidate for concussion.

Southern Star Research is a globally recognized, full-service CRO with a proven track record in delivering early-phase trials across Australia and Asia-Pacific. Their deep operational expertise, regulatory knowledge, and hands-on site management capabilities will support the execution of Oragenics’ randomized, double-blind, placebo-controlled Phase IIa study evaluating ONP-002 in adults with mild traumatic brain injury (mTBI).

Read more about Oragenics Selects Southern Star Research As Clinical Research Organization for ONP-002 Phase IIa Trial.

This agreement is expected to ensure Good Manufacturing Practice (GMP)-compliant drug product supply ahead of the planned Phase IIb clinical trials which the Company expects to start next year. The collaboration marks an important milestone for Oragenics as it secures domestic production capabilities to support its upcoming clinical and regulatory efforts.

This submission marks a critical milestone in advancing the Company’s Phase II clinical trial evaluating ONP-002, its proprietary neurosteroid therapy, for the treatment of mild traumatic brain injury (mTBI) or concussion. Pending approval, Oragenics expects to initiate patient enrollment in the region and expand the study’s geographic reach. The trial is expected to be conducted at Christchurch Hospital in New Zealand, the largest tertiary, teaching, and research hospital on the South Island. Christchurch Hospital provides a full range of emergency, acute, elective, and outpatient services, and its Emergency Department is one of the busiest in Australasia, treating more than 83,000 patients annually.

ONP-002 has demonstrated promising preclinical results, showing the potential to reduce inflammation, oxidative stress, and brain swelling. A prior Phase I study in healthy adults confirmed the drug’s safety and tolerability at multiple intranasal doses. This upcoming Phase II study aims to establish the feasibility of acute intranasal administration in mTBI patients and generate initial proof-of-concept data through cognitive testing, visual motor testing, and biomarker analysis.

Oragenics’ lead drug candidate, ONP-002, is a new chemical entity (NCE) designed to target the brain through delivery into the nasal cavity and onward to the brain. A Phase II study is being designed to analyze the effectiveness of ONP-002 on blood biomarkers and patient-reported outcomes of concussed patients.

Loss of consciousness along with acute memory impairment are linked to prolonged post-concussion symptoms and poor clinical outcomes. Oragenics’ breath-propelled device requires the patient to administer ONP-002 into the nose. Concussed patients with an acute altered mental state may not be capable of following these instructions. Oragenics intends to use its breath-propelled device in the planned Phase II trial, which calls for multiple days of treatment.

However, for those patients who have a loss of consciousness or altered mental status early on, the current automated prototype is being developed for their initial treatment by medical staff during the period in which they may struggle to follow directions for blowing.