FAQ on Oragenics Inc.'s Phase IIa Trial of ONP-002 for Concussion Treatment
Summary
What is ONP-002?
ONP-002 is a proprietary intranasal neurosteroid developed by Oragenics Inc. designed to enhance brain delivery while reducing systemic exposure, aimed at treating mild traumatic brain injury (mTBI) or concussion.
Why is the Phase IIa trial of ONP-002 significant?
The trial represents a pivotal step in advancing ONP-002 towards addressing the significant unmet need in concussion treatment, evaluating its safety, tolerability, pharmacokinetics, and early pharmacodynamic effects.
Who is conducting the Phase IIa trial of ONP-002?
Oragenics Inc. has chosen Southern Star Research as its Clinical Research Organization (CRO) to conduct the randomized, double-blind, placebo-controlled Phase IIa trial of ONP-002.
Where will the Phase IIa trial of ONP-002 take place?
The trial has secured Human Research Ethics Committee approval in Australia, with Oragenics and Southern Star Research finalizing site selection and preparing for patient enrollment.
What are the goals of the Phase IIa trial for ONP-002?
The trial aims to evaluate the safety, tolerability, pharmacokinetics, and early pharmacodynamic effects of ONP-002 in patients with mild traumatic brain injury.
How does ONP-002 work?
ONP-002 is designed as an intranasal neurosteroid that enhances brain delivery while reducing systemic exposure, targeting the treatment of mild traumatic brain injury (mTBI) or concussion.
What is Oragenics Inc.’s focus?
Oragenics Inc. is a clinical-stage biotechnology company focused on nasal delivery of pharmaceutical medications in neurology and fighting infectious diseases, including treatments for mTBI and Niemann Pick Disease Type C (NPC).
Where can I find more information about Oragenics Inc. and ONP-002?
More information is available on Oragenics Inc.’s website at www.Oragenics.com and the latest news and updates relating to OGEN are available in the company’s newsroom at https://ibn.fm/OGEN.
Who is the CEO of Oragenics Inc.?
Janet Huffman is the CEO of Oragenics Inc., who stated that the partnership with Southern Star Research marks a pivotal step in advancing ONP-002.
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