GM $ODYY huge news out!!
ODYSSEY HEALTH, INC, SELECTS SYNEOS HEALTH TO SUPPORT INVESTIGATIONAL NEW DRUG APPLICATION FOR TREATMENT OF CONCUSSION
LAS VEGAS, NV / ACCESSWIRE / November 16, 2023 / Odyssey Health, Inc. (OTCQB:ODYY), f/k/a Odyssey Group International, Inc., a company focused on developing unique, life-enhancing medical products, has selected Syneos Health®, a leading fully integrated biopharmaceutical solutions organization to support its Investigational New Drug (IND) Application. Odyssey Health is developing a pharmaceutical treatment for mild Traumatic Brain Injury (mTBI), aka concussion.
Odyssey Health's lead drug candidate for concussion, ONP-002 has completed a Phase I safety trial in Australia. Odyssey submitted a pre-IND application to the FDA this summer and received instructive feedback in September. In preparation for IND submission and clinical trials in the US, Odyssey chose Syneos Health for guidance and review of all pre-clinical and clinical data needed for the final IND package and support of the clinical design protocol for the Phase II clinical trial to be conducted in the US. Syneos Health's expertise combined with the Company's familiarity with the drug candidate and nasal delivery technology further helps position the study for success.
Along with other fully integrated biopharmaceutical solution services, Syneos Health brings global regulatory affairs solutions (GRAS), providing end-to-end regulatory support across many indications and regions. The Syneos Health GRAS 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," stated Michael Redmond, CEO of Odyssey Health.
