Oragenics Advance ONP-002 to Phase II Trial for Brain Injury
Oragenics Takes a Significant Step Forward in mTBI Research
Oragenics, Inc. (NYSE American: OGEN), a pioneering biotechnology firm, is making strides in developing groundbreaking treatments for concussion and other brain health conditions. Recently, the company announced the submission of its Investigator's Brochure (IB) application, which is crucial for initiating their Phase II clinical trial involving ONP-002, a novel intranasal neurosteroid.
Understanding ONP-002's Potential
ONP-002 has shown encouraging preclinical results, indicating its ability to combat inflammation, oxidative stress, and brain swelling. The drug was previously evaluated in a Phase I study focusing on healthy participants, confirming its safety and tolerability across various intranasal doses. Looking ahead, the Phase II study aims to determine the feasibility of administering ONP-002 to patients who have suffered mild traumatic brain injuries (mTBI) and to provide preliminary proof-of-concept through several evaluative methods including cognitive and visual motor tests, as well as biomarker analysis.
Components of the Investigator's Brochure
The IB is a critical document that provides research investigators with detailed clinical and non-clinical information regarding ONP-002, encompassing vital aspects such as its safety profile, pharmacokinetics, and pharmacodynamics. This comprehensive guide is essential for informing investigators about necessary protocols such as dosing regimens and monitoring methods for patient safety. Additionally, the submission of the IB updates ClinicalTrials.gov with essential details about the trial, ensuring transparency throughout the research process as it advances through regulatory approval stages.
The Impact of Mild TBI
Mild traumatic brain injury, often referred to as concussion, represents a prevalent form of head trauma that can temporarily impair brain function. Common symptoms include headaches, dizziness, and cognitive challenges. Despite the significant occurrence of concussions, there are currently no FDA-approved medications available for treatment, creating a considerable gap in the healthcare landscape that needs to be addressed.
“The submission of our Investigator’s Brochure application marks a critical step forward in advancing our clinical program for ONP-002,” stated Janet Huffman, Interim CEO of Oragenics. She emphasized the importance of this submission in moving closer to the clinical trial phase, underscoring the company's commitment to delivering essential therapeutic options to those suffering from mTBI. Oragenics is optimistic about receiving the necessary regulatory approvals to commence the trial shortly, and is dedicated to ensuring a seamless launch while keeping stakeholders updated on their progress.
About the Upcoming Phase II Clinical Trial
The Phase II trial is designed to be randomized, double-blind, and placebo-controlled. Its primary goal is to evaluate the feasibility, safety, tolerability, and pharmacokinetic properties of ONP-002 in adults diagnosed with mTBI. The enrollment goal is set at 40 participants, divided evenly between those receiving ONP-002 and those receiving a placebo. Each participant will receive nine doses over five days, with the initial dose administered swiftly within 12 hours following an injury. To assess ONP-002's effectiveness, cognitive assessments, visual motor testing, and blood biomarker evaluations will be employed to meticulously analyze brain function recovery.
Contact Information for Investors
For those seeking further information, Rich Cockrell is available for inquiries. He can be reached at 404.736.3838 or via email at ogen@cg.capital.
Explore More About Oragenics, Inc.
Oragenics is a dynamic, development-stage biotechnology company focused on employing innovative nasal delivery systems for medical treatments in neurology and infectious diseases. Its research extends to developing solutions for mild traumatic brain injury as well as Niemann Pick Disease Type C (NPC). Further information about Oragenics' endeavors can be found at www.oragenics.com.
Frequently Asked Questions
What is ONP-002?
ONP-002 is a novel intranasal neurosteroid being developed by Oragenics for treating mild traumatic brain injury.
What are the key goals of the Phase II trial?
The trial's primary goals are to assess the feasibility, safety, and effectiveness of ONP-002 in mTBI patients.
How does the Investigator's Brochure assist in the trial?
The IB provides investigators with essential data on ONP-002's safety and administration protocols necessary for conducting the trial.
What are the expected outcomes of the trial?
The trial aims to deliver proof-of-concept data on ONP-002's effectiveness through cognitive and biomarker testing.
Who can I contact for more information about Oragenics?
Rich Cockrell is the designated contact for investor inquiries at Oragenics.
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