Oragenics Completes Spray Dry Drug Manufacturing
Oragenics, Inc. (NYSE American: OGEN) is dedicated to developing innovative intranasal pharmaceuticals aimed at treating neurological disorders. The company recently announced that it has successfully completed the spray-drying formulation and filling process for its lead candidate, ONP-002, which is specifically designed to address concussions. This new chemical entity (NCE) targets the brain by delivering medication through the nasal cavity.
Preparations for Phase IIa Clinical Trial
Oragenics has produced both the placebo and the ONP-002 drug for the upcoming Phase IIa clinical trial, which will involve 40 patients who have suffered concussions. This trial will assess the drug's effects in comparison to a placebo, with participants receiving doses twice daily for five consecutive days after their injury. The goal is to initiate treatment within eight hours of the injury and to evaluate patient-reported outcomes along with blood biomarkers.
Innovative Delivery Method
Michael Redmond, the President of Oragenics, emphasized that formulating ONP-002 as a nanoparticle for intranasal delivery is essential for enhancing brain exposure. This groundbreaking neurosteroid aims to mitigate adverse outcomes following a concussion, making the spray-dried powder in the delivery device particularly suitable for use in the field. This advancement could significantly improve the chances of addressing concussive injuries promptly.
The Importance of Addressing Concussions
Concussions pose a significant unmet medical challenge, with approximately 69 million cases reported globally each year. They often result from falls, motor vehicle accidents, and contact sports. The consequences of concussions can lead to serious neurological disorders, and about 20% of those affected continue to experience ongoing symptoms.
About Oragenics
Oragenics is a biotechnology company in the development stage that focuses on nasal delivery systems for pharmaceuticals targeting infectious diseases and neurological conditions. The company is committed to creating treatments for mild traumatic brain injuries (mTBI) and Niemann-Pick Disease Type C (NPC), utilizing proprietary powder formulations and advanced intranasal devices.
Company Contact Information
For further information regarding Oragenics, please reach out to:
Janet Huffman, Chief Financial Officer
813-286-7900
Email: jhuffman@oragenics.com
Investor Relations:
Rich Cockrell
CG Capital
404-736-3838
Email: ogen@cg.capital
Frequently Asked Questions
What is ONP-002?
ONP-002 is Oragenics' lead drug candidate, designed for intranasal delivery to treat concussions.
When will the Phase IIa clinical trial start?
The trial is anticipated to begin once the drug manufacturing and device preparation are completed.
How many patients will participate in the trial?
The trial plans to enroll 40 concussed patients to evaluate the effects of ONP-002 compared to a placebo.
What is the method of delivery for ONP-002?
ONP-002 will be administered intranasally using a cutting-edge breath-propelled device, ensuring effective delivery.
Why are concussions a significant concern?
Concussions can result in serious neurological issues and long-term disabilities, underscoring the urgent need for effective treatment options.
