Odyssey Health, Inc., a company focused on developing life-enhancing medical products, has selected Syneos Health, a biopharmaceutical services organization to support its Investigational New Drug (IND) Application. Odyssey Health is developing a pharmaceutical treatment for mild Traumatic Brain Injury (mTBI).
Odyssey’s lead candidate for concussion, ONP-002 has completed a Phase I safety trial and the company submitted a pre-IND application to the FDA and received instructive feedback in September. In preparation for IND submission and clinical trials in the U.S., Odyssey chose Syneos Health for guidance and review of all preclinical and clinical data needed for the final IND package and support of the clinical design protocol for the Phase II trial.
Syneos Health’s global regulatory affairs services team will support Odyssey with a regulatory review for the clinical development plans for Odyssey’s concussion drug, ONP-002 and novel intranasal device. As a class II drug: device combination Syneos Health will assist Odyssey in getting the needed advice for Phase II/III clinical trial design and implementation from the FDA.
“Odyssey is excited to partner with such a respected group of experts. Syneos Health has been a global leader in clinical trials for decades and has a strong track record working with the FDA. Furthermore, Syneos Health brings a regulatory affairs team that has years of experience with neurological drugs and intranasal devices. We believe that intranasal drug delivery in the acute phase following concussion is critical to dampening brain inflammation and improving patient outcomes,” said Michael Redmond, CEO of Odyssey Health.
