Odyssey Health, Inc. (ODYY) Updates Progress of its Concussion Drug Development Program; Communicating with the FDA for permission to start phase II clinical trial of its PRV-002 Drug Candidate
- Odyssey acquired IP and all rights to PRV-002, its lead drug candidate for the treatment of concussions, on March 1, 2021, and has since made notable progress in a strategic move to have the drug approved by the FDA
- Since the acquisition, the company has completed IND enabling studies and all cohorts for Phase I SAD and MAD clinical trials for its lead drug candidate
- In pre-clinical studies PRV-002 has demonstrated equivalent, if not superior neuroprotective effects compared to related neurosteroids, offering proof of reduced behavioral pathology associated with brain injury symptoms, easily crossing the blood-brain barrier to rapidly eliminate swelling, oxidative stress, and inflammation in the brain
- Odyssey’s management is pleased with the progress so far, as the drug advances in its clinical and regulatory pathway and, subsequently, tapping into the concussion treatment market projected to be valued at $8.9 billion by 2027
On March 1, 2021, Odyssey Health (OTC: ODYY), a medical company with a focus on unique, life-saving medical products that offer clinical advantages to unmet clinical needs, acquired intellectual property (“IP”) and all rights to PRV-002, its lead drug candidate for the treatment of concussions (https://nnw.fm/VtRQz ). For a condition affecting millions worldwide, Odyssey recognized a significant unmet medical need and set off to offer a viable solution to the problem.
Since the acquisition of the rights, the company has embarked on an aggressive push to develop its program and advance its drug candidate through the regulatory process required by the United States Food and Drug Administration (“FDA”). Its key achievements thus far include successfully completing the processes involved with Investigational New Drug (“IND”) applications, which paved the way for safety studies for the Phase I human clinical trial.
Odyssey also successfully developed its nanoparticle drug formulation, in addition to filing a patent application on the unique breath-propelled intranasal delivery device. On September 28, 2022, the company announced the completion of all cohorts for its Phase I Single Ascending Dosing (“SAD”) and Multiple Ascending Dosing (“MAD”) clinical trials for PRV-002, with the drug proving safe and well tolerated throughout the trial. The success of these trials paved the way for the next phase of its clinical study, with the company expressing its satisfaction and optimism for what lies ahead.
“I am excited to see that Odyssey’s drug was considered safe throughout the Phase I study,” noted Francis Beaudette, a retired Commanding General of the United States Army Special Operations Command.
“Now we can start the important work to determine the efficacy of PRV-002, a much-needed brain injury solution for the military and beyond,” he added (https://nnw.fm/KtNrC ).
This announcement followed the formation of a Military Advisory Board within Odyssey that brought on board distinguished military veterans who would assist the company in selecting military sites for the Phase II clinical trial, another critical milestone for the company.
According to the World Health Organization (“WHO”), approximately 1.3 million people die annually from head injuries in road crashes. In addition, the Journal of Neurosurgery notes that almost 64-74 million people may suffer from a concussion yearly, with the highest cases in Southeast Asian and Western Pacific regions (https://nnw.fm/wD58Z ).
In the sports sector, nearly 1.6-3.8 million athletes suffer from concussions annually, according to the Brain Injury Research Institute. In addition, 10% of all contact sports athletes sustain concussions yearly, yet there is still no viable treatment option for these conditions.
In pre-clinical studies Odyssey’s PRV-002 has demonstrated equivalent, if not superior, neuroprotective effects compared to related neurosteroids. This fully synthetic, non-naturally occurring neurosteroid has proven to successfully reduce the behavioral pathology associated with brain injury symptoms such as memory impairment, motor/sensory performance, and anxiety. Most notably, it has been shown to easily cross the blood-brain barrier to rapidly eliminate swelling, oxidative stress, and inflammation in the brain while restoring proper blood flow.
The company is currently communicating with the FDA to present findings from its Phase I trial. Phase II trial sites are also being identified, and study design is being created with the site’s medical leadership and the Odyssey Medical Advisors.
Odyssey’s management is pleased with the progress, even as it looks forward to FDA approval. It is also looking to tap into the concussion treatment market, projected to be valued at $8.9 billion by 2027, up from $6.9 billion in 2020.
For more information, visit the company’s website at www.OdysseyHealthInc.com.
NOTE TO INVESTORS: The latest news and updates relating to ODYY are available in the company’s newsroom at https://nnw.fm/ODYY
Please see full disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
- Odyssey acquired IP and all rights to PRV-002, its lead drug candidate for the treatment of concussions, on March 1, 2021, and has since made notable progress in a strategic move to have the drug approved by the FDA
- Since the acquisition, the company has completed IND enabling studies and all cohorts for Phase I SAD and MAD clinical trials for its lead drug candidate
- In pre-clinical studies PRV-002 has demonstrated equivalent, if not superior neuroprotective effects compared to related neurosteroids, offering proof of reduced behavioral pathology associated with brain injury symptoms, easily crossing the blood-brain barrier to rapidly eliminate swelling, oxidative stress, and inflammation in the brain
- Odyssey’s management is pleased with the progress so far, as the drug advances in its clinical and regulatory pathway and, subsequently, tapping into the concussion treatment market projected to be valued at $8.9 billion by 2027
On March 1, 2021, Odyssey Health (OTC: ODYY), a medical company with a focus on unique, life-saving medical products that offer clinical advantages to unmet clinical needs, acquired intellectual property (“IP”) and all rights to PRV-002, its lead drug candidate for the treatment of concussions (https://nnw.fm/VtRQz ). For a condition affecting millions worldwide, Odyssey recognized a significant unmet medical need and set off to offer a viable solution to the problem.
Since the acquisition of the rights, the company has embarked on an aggressive push to develop its program and advance its drug candidate through the regulatory process required by the United States Food and Drug Administration (“FDA”). Its key achievements thus far include successfully completing the processes involved with Investigational New Drug (“IND”) applications, which paved the way for safety studies for the Phase I human clinical trial.
Odyssey also successfully developed its nanoparticle drug formulation, in addition to filing a patent application on the unique breath-propelled intranasal delivery device. On September 28, 2022, the company announced the completion of all cohorts for its Phase I Single Ascending Dosing (“SAD”) and Multiple Ascending Dosing (“MAD”) clinical trials for PRV-002, with the drug proving safe and well tolerated throughout the trial. The success of these trials paved the way for the next phase of its clinical study, with the company expressing its satisfaction and optimism for what lies ahead.
“I am excited to see that Odyssey’s drug was considered safe throughout the Phase I study,” noted Francis Beaudette, a retired Commanding General of the United States Army Special Operations Command.
“Now we can start the important work to determine the efficacy of PRV-002, a much-needed brain injury solution for the military and beyond,” he added (https://nnw.fm/KtNrC ).
This announcement followed the formation of a Military Advisory Board within Odyssey that brought on board distinguished military veterans who would assist the company in selecting military sites for the Phase II clinical trial, another critical milestone for the company.
According to the World Health Organization (“WHO”), approximately 1.3 million people die annually from head injuries in road crashes. In addition, the Journal of Neurosurgery notes that almost 64-74 million people may suffer from a concussion yearly, with the highest cases in Southeast Asian and Western Pacific regions (https://nnw.fm/wD58Z ).
In the sports sector, nearly 1.6-3.8 million athletes suffer from concussions annually, according to the Brain Injury Research Institute. In addition, 10% of all contact sports athletes sustain concussions yearly, yet there is still no viable treatment option for these conditions.
In pre-clinical studies Odyssey’s PRV-002 has demonstrated equivalent, if not superior, neuroprotective effects compared to related neurosteroids. This fully synthetic, non-naturally occurring neurosteroid has proven to successfully reduce the behavioral pathology associated with brain injury symptoms such as memory impairment, motor/sensory performance, and anxiety. Most notably, it has been shown to easily cross the blood-brain barrier to rapidly eliminate swelling, oxidative stress, and inflammation in the brain while restoring proper blood flow.
The company is currently communicating with the FDA to present findings from its Phase I trial. Phase II trial sites are also being identified, and study design is being created with the site’s medical leadership and the Odyssey Medical Advisors.
Odyssey’s management is pleased with the progress, even as it looks forward to FDA approval. It is also looking to tap into the concussion treatment market, projected to be valued at $8.9 billion by 2027, up from $6.9 billion in 2020.
For more information, visit the company’s website at www.OdysseyHealthInc.com.
NOTE TO INVESTORS: The latest news and updates relating to ODYY are available in the company’s newsroom at https://nnw.fm/ODYY
Please see full disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
