FAQ on Oragenics Inc.'s Phase IIa Trial of ONP-002 for Concussion Treatment

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) for the upcoming 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 finalizing site selection and preparing for patient enrollment.

What are the goals of the Phase IIa trial for ONP-002?

The randomized, double-blind, placebo-controlled study aims to evaluate the safety, tolerability, pharmacokinetics, and early pharmacodynamic effects of ONP-002 in mild traumatic brain injury.

How can I learn more about Oragenics Inc.?

For more information about Oragenics Inc., visit the company’s website at www.Oragenics.com.

Where can I find the latest news and updates about OGEN?

The latest news and updates relating to OGEN are available in the company’s newsroom at https://ibn.fm/OGEN.

What other conditions is Oragenics Inc. targeting with its drug candidates?

Besides mild traumatic brain injury, Oragenics Inc. is also developing drug candidates for treating Niemann Pick Disease Type C (NPC), along with proprietary powder formulation and an intranasal delivery device.