Oragenics Advances ONP-002 for Concussion Treatment
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Oragenics Completes Spray Dry Drug Manufacturing
Oragenics, Inc. (NYSE American: OGEN) is a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders. The company has announced the completion of its spray-dried formulation and filling in the nasal device for its lead candidate, ONP-002, aimed at treating concussions. This new chemical entity (NCE) is designed to target the brain through delivery into the nasal cavity.
Preparations for Phase IIa Clinical Trial
The company has produced both placebo and ONP-002 drug for use in the upcoming Phase IIa clinical trial, which will enroll 40 concussed patients. The trial will compare the effects of the drug against a placebo, with dosing given twice a day for five consecutive days following injury. The trial aims to start treatment within eight hours of an injury and will evaluate patient-reported outcomes and blood biomarkers.
Innovative Delivery Method
Michael Redmond, President of Oragenics, stated that the formulation of ONP-002 as a nanoparticle for intranasal delivery is crucial for improving brain exposure. The novel neurosteroid is designed to reduce negative outcomes following a concussion, positioning the spray-dried powder in the delivery device as ideal for field use. This innovation may significantly enhance the chances of addressing concussive injuries early.
The Importance of Addressing Concussions
Concussions represent a major unmet medical need, with an estimated 69 million cases reported annually worldwide. Common causes include falls, motor vehicle accidents, and contact sports. Concussions can lead to serious neurological disorders, and ongoing symptoms affect approximately 20% of those affected.
About Oragenics
Oragenics is a development-stage biotechnology company emphasizing nasal delivery for pharmaceuticals targeting infectious diseases and neurological conditions. The company focuses on developing treatments for mild traumatic brain injuries (mTBI) and Niemann-Pick Disease Type C (NPC), leveraging proprietary powder formulations and advanced intranasal devices.
Company Contact Information
For more information about Oragenics, please contact:
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 the lead drug candidate from Oragenics designed for intranasal delivery to treat concussions.
When will the Phase IIa clinical trial start?
The trial is expected to begin following the completion of drug manufacturing and device preparation.
How many patients will participate in the trial?
The trial aims to enroll 40 concussed patients for evaluation of ONP-002 against a placebo.
What is the method of delivery for ONP-002?
ONP-002 will be delivered intranasally using a novel breath-propelled device, ensuring efficient administration.
Why are concussions a significant concern?
Concussions can lead to severe neurological conditions and long-term disabilities, highlighting the need for effective treatments.
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