Oragenics Inc. (NYSE American: OGEN) is currently preparing for Phase IIa clinical trials in concussed patients, as reported in the press release on August 21, 202412. The company has completed the spray-dried formulation and filling of the nasal device for its lead candidate, ONP-002, which is designed to target the brain through delivery into the nasal cavity. The prefilled formulation is intended to provide the needed drug-device dosing for the planned Phase IIa clinical trial.
The Phase IIa clinical trial is expected to enroll 40 concussed patients who will receive either a placebo or the ONP-002 drug, with doses given twice a day for five consecutive days following injury. The trial aims to start treatment within 8 hours of the injury in the emergency department and will evaluate patient-reported outcomes and blood biomarkers. The company has produced both placebo and ONP-002 drug for use in the Phase IIa clinical trial to be conducted in Australia, and has initiated a stability program of both the drug formula alone and within the device.
In preparation for the Phase IIa study, Oragenics ensured that ONP-002 could be formulated as a nanoparticle and delivered intranasally as a powder to improve brain exposure. The anti-inflammatory effects of the novel neurosteroid are designed to reduce negative outcomes after a concussion, and the company believes the combination of the spray-dried powder in their device is ideal for field delivery, increasing the chances of stopping the neuropathology of a concussive injury early12.
The completion of the spray-dried formulation and filling of the nasal device is a significant milestone for Oragenics, as it demonstrates their commitment to developing a pharmaceutical treatment for concussion, a condition for which no pharmaceutical treatment is currently available34. The company's focus on intranasal delivery of pharmaceutical medications is also noteworthy, as it offers a novel approach to treating neurological disorders and infectious diseases14.
9/25/2024 03:35pm
