- Odyssey Health is a medical company focused on developing unique, life-saving medical products that offer clinical advantages for unmet clinical needs
- Recently, the company reported positive results from Cohort I of its Multi-Day Ascending Dosing (“MAD”) portion of its Phase I clinical trial, coming weeks after the successful completion of Phase I Single Ascending Dosing (“SAD”) clinical trial
- The MAD arm thus far shows that the drug is safe and well tolerated
- Odyssey expects to report additional MAD results as they become available
A few weeks after completing its Phase I Single Ascending Dosing (“SAD”) clinical trial, Odyssey Health (OTC: ODYY) recently announced positive results from Cohort I of its Multi-Day Ascending Dosing (“MAD”) portion for its Phase I clinical trial evaluating the efficacy and safety of PRV-002 (https://nnw.fm/TpS6H), the company’s novel drug candidate for treating concussion.
For Odyssey, a medical company focused on creating and commercializing unique, life-improving medical products, concussion – a mild traumatic brain injury (“mTBI”) caused by a jolt, bump, or blow to the head – represented an unmet clinical need. Despite its high prevalence in the U.S., with figures showing that as many as five million concussions occur annually (https://nnw.fm/9Vcg5), the condition does not have a Food and Drug Administration (“FDA”)-approved drug.
“Odyssey’s primary drug candidate is being developed as the first treatment for concussion,” a white paper posted on the company’s website reads (https://nnw.fm/gC5PP). “The drug candidate, PRV-002, is a novel neurosteroid that easily crosses the blood-brain barrier.”
The company completed the GMP synthesis of PRV-002 and all pre-clinical efficacy studies, which showed that the drug candidate “improves behavioral (working memory, motor performance, and anxiety levels) and molecular (inflammation, oxidative stress, and swelling) outcomes following brain trauma through an amplified neuroprotective gene response internal to cells in the brain,” and has now embarked on human trials. As part of the ongoing human study, grouped into SAD and MAD portions, Odyssey is administering PRV-002 to healthy human subjects.
The successfully completed SAD arm of the Phase I trial involving three cohorts showed the drug was safe and well tolerated, influencing expectations and confidence that PRV-002 will continue to show safety during the MAD portion of the trial.
“We have unanimously approved the start of MAD Cohort I,” commented Dallas Hack, MD, member of the Safety Review Committee, following the completion of Phase I SAD trial (https://nnw.fm/RFhvB). “I am especially excited to see the overall low levels of PRV-002 in the blood supporting the hypothesis that more drug is getting to the brain itself when administered with the intranasal device. If this turns out to be the case, not only can the targeted effects of the drug be more efficacious, the drug will likely have less potential side effects.”
And with Odyssey having recently announced positive results from Cohort I of the MAD arm of the study, Odyssey’s Phase I clinical trial appears to be ticking all the expected checkboxes. According to the company, the MAD Cohort I (eight healthy subjects) received one low dose of intranasal PRV-002 for five consecutive days, followed by evaluations that showed the drug was safe and well tolerated.
“I am very happy to see these positive safety results when dosing for multiple days. PRV-002 appears to be well-tolerated when given intranasally. If PRV-002 is found to be efficacious for concussed patients in the Phase II/III trials, I believe that intranasal brain-targeting will be the key to its success. So far, the intranasal drug/device combination has functioned nicely and has been well-tolerated in the clinical setting,” said Dr. Jacob VanLandingham, the head of drug development for the PRV-002 concussion treatment at Odyssey Health, of the recent positive results.
The Phase I MAD clinical trial will involve 16 healthy subjects, with the subsequent cohorts receiving a higher dose than Cohort I. The company expects to report additional MAD results as they become available.
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
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