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.
About Odyssey Health Inc. (formerly Odyssey Group International, Inc.)
Odyssey Health Inc. (OTC: ODYY) is a medical company with a focus in the area of life-saving medical solutions. Odyssey's corporate mission is to create, acquire and develop distinct assets, intellectual property, and exceptional technologies that provide meaningful medical solutions. The company is focused on areas that have an identified technological advantage, provide superior clinical utility, and have a substantial market opportunity. For more information, visit the company's website at www.odysseyhealthinc.com
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About Our Drug Candidate
Our drug candidate is a fully synthetic non-naturally occurring neurosteroid being developed for the treatment of moderate traumatic brain injury. In preclinical studies, the drug has demonstrated equivalent, if not superior, neuroprotective effects compared to related neurosteroids. Animal models of concussion demonstrated that the drug reduces the behavioral pathology associated with brain injury symptoms such as memory impairment, anxiety, and motor/sensory performance. Additionally, the drug is lipophilic and in pre-clinical studies has shown it can easily cross the blood-brain barrier to rapidly eliminate swelling, oxidative stress and inflammation in the brain while restoring proper blood flow. Our novel breath-propelled, intranasal brain-drug delivery device is designed with a novel drug dispensing system that creates an effective airflow for depositing concentrated drug deep into the nasal cavity and onto the olfactory region, this could allow for quick and direct diffusion into the brain.
Forward-Looking Statements
This news release may contain forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including our ability to continue to raise needed funds, successfully complete additional clinical studies, our ability to successfully develop products, rapid changes in our markets, changes in demand for our future products, and legislative, regulatory, competitive developments and general economic conditions.
Inquiries:
Odyssey Health
info@odysseyhealthinc.com
SOURCE: Odyssey Health, Inc.
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