EXCLUSIVE: Oragenics Completes Spray Dry Drug Manufacturing, Intranasal Device Filling For Anticipated Mid-Stage Study For Patients With Brain Injury

Wednesday, Oragenics Inc. OGEN announced the completion of its spray-dried formulation and filling in the nasal device for its lead candidate, ONP-002, for concussion.

Oragenics is a development-stage biotechnology company focused on nasal delivery of pharmaceutical medications for infectious diseases and neurological conditions, including drug candidates for mild traumatic brain injury (mTBI), also known as concussion, and Niemann Pick Disease Type C (NPC), as well as proprietary powder formulation and an intranasal delivery device.

Also Read: EXCLUSIVE: Oragenics’ Concussion Drug Clears FDA-Required Cardiotoxicity Testing, Planning For Phase II Trials Underway.

ONP-002 is a new chemical entity (NCE) 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 2a clinical trial in concussed patients.

For the trial, the company produced a placebo and ONP-002 drug for use in the Phase 2a clinical trial to be conducted in Australia.

The work included producing ONP-002 as a spray-dried nanoparticle formulation, loading the powder in Oragenics’ breath-propelled intranasal device, and initiating a stability program of the drug formula alone and within the device.

The Phase 2a clinical trial is expected to enroll 40 concussed patients who receive 1:1 either placebo or the ONP-002 drug, with doses given twice daily for five consecutive days following injury.

The trial aims to start treatment within 8 hours of the injury in the emergency department.

Patient-reported outcomes and blood biomarkers are anticipated to be included in the evaluation.

“In preparing for the Phase IIa study, we wanted to ensure that ONP-002 could be formulated as a nanoparticle and delivered intranasally as a powder to improve brain exposure. The anti-inflammatory effects of our novel neurosteroid are designed to reduce negative outcomes after a concussion. We believe the combination of the spray-dried powder in our device is ideal for field delivery, increasing the chances of stopping the neuropathology of a concussive injury early,” commented Michael Redmond, President of Oragenics.

Price Action: OGEN stock closed at $0.93 on Tuesday.

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