Neurosteroid

PureTech's LYT-300 (Oral Allopregnanolone) Achieved Primary Endpoint in a Phase 2a Acute Anxiety Trial in Healthy Volunteers

Retrieved on: 
Tuesday, November 14, 2023
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The trial was designed to evaluate the salivary cortisol response in the Trier Social Stress Test (TSST), a validated clinical model of anxiety in healthy volunteers.

Key Points: 
  • The trial was designed to evaluate the salivary cortisol response in the Trier Social Stress Test (TSST), a validated clinical model of anxiety in healthy volunteers.
  • View the full release here: https://www.businesswire.com/news/home/20231113556006/en/
    PureTech announced topline results from its Phase 2a, randomized, placebo-controlled, proof-of-concept trial of LYT-300 (oral allopregnanolone).
  • The trial was designed to evaluate the salivary cortisol response in the Trier Social Stress Test (TSST), a validated clinical model of anxiety in healthy volunteers.
  • An increase in cortisol levels after the TSST is a physiological response and an objective biomarker of acute stress.

PureTech Initiates Phase 2a Clinical Trial of LYT-300 (Oral Allopregnanolone) for the Potential Treatment of Anxiety Disorders

Retrieved on: 
Wednesday, June 21, 2023
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LYT-300 is PureTech’s wholly-owned therapeutic candidate for the potential treatment of neurological and neuropsychiatric disorders, including anxiety disorders and postpartum depression (PPD).

Key Points: 
  • LYT-300 is PureTech’s wholly-owned therapeutic candidate for the potential treatment of neurological and neuropsychiatric disorders, including anxiety disorders and postpartum depression (PPD).
  • These oral analogs may have different pharmacological effects than endogenous allopregnanolone and therefore may not capture its full therapeutic potential.
  • Results for the placebo-controlled, Phase 2a, proof-of-concept trial using a validated clinical model of anxiety in healthy volunteers are anticipated by the end of 2023.
  • Additionally, the open-label, Phase 2a, proof-of-concept clinical trial in patients with postpartum depression is expected to begin in the second half of 2023.

Odyssey Health, Inc. Makes Statement Regarding its Concussion Drug Development Program

Retrieved on: 
Friday, September 30, 2022
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The sports advisory members have been outspoken advocates for concussion prevention and for the importance of finding responsible treatments.

Key Points: 
  • The sports advisory members have been outspoken advocates for concussion prevention and for the importance of finding responsible treatments.
  • We have recently completed a Phase I human trial where our drug was proven to be safe and well tolerated.
  • The press has misrepresentedOdyssey Health, Inc. Odyssey has never directly or indirectly received money from state or federal government sources to fund the drug development.
  • Odyssey wants to continue its focus on this important drug candidate in hopes of providing a much-needed treatment.

Odyssey Health, Inc. Announces Positive Results from Its Phase I Multi-Day Ascending Dosing for the Treatment of Concussion

Retrieved on: 
Wednesday, August 10, 2022
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Odysseys trial is administering PRV-002, its novel drug to treat concussion, to healthy human subjects.

Key Points: 
  • Odysseys trial is administering PRV-002, its novel drug to treat concussion, to healthy human subjects.
  • Dr. Jacob VanLandingham of Odyssey Health, Inc. commented, As the head of drug development for the PRV-002 concussion treatment, I was very happy to see these positive safety results when dosing for multiple days.
  • The Phase I Single Ascending Dosing (SAD) arm has successfully been completed and was well-tolerated.
  • PRV-002 is a fully synthetic non-naturally occurring neurosteroid being developed for the treatment of mTBI (concussion).

Odyssey Health, Inc. Launches New Corporate Website

Retrieved on: 
Thursday, August 4, 2022
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Odyssey Group International, Inc. (OTC: ODYY) is a technology and asset acquisition company with a focus in the area of life saving medical solutions.

Key Points: 
  • Odyssey Group International, Inc. (OTC: ODYY) is a technology and asset acquisition company with a focus in the area of life saving medical solutions.
  • Odyssey's corporate mission is to create, acquire and accumulate distinct assets, intellectual properties, and exceptional technologies that provide meaningful medical solutions.
  • PRV-002 is a fully synthetic non-naturally occurring neurosteroid being developed for the treatment of mTBI (concussion).
  • In preclinical studies, PRV-002 has demonstrated equivalent, if not superior, neuroprotective effects compared to related neurosteroids.

Odyssey Health, Inc. Successfully Completes Phase I Single Ascending Dosing for Intranasal Concussion Drug

Retrieved on: 
Tuesday, July 12, 2022
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Odysseys trial involves administering PRV-002, the Companys novel drug to treat concussion, to healthy human subjects.

Key Points: 
  • Odysseys trial involves administering PRV-002, the Companys novel drug to treat concussion, to healthy human subjects.
  • A single concussion can significantly increase the risk of Alzheimers Disease and other neuropsychiatric disorders.
  • Pharmacokinetic analysis showed a direct linear relationship between drug dosing concentration and blood plasma levels across all three cohorts of SAD.
  • Odyssey is currently scheduling a meeting with the FDA to present the findings from the Phase 1 Trial.

Odyssey Health, Inc. Completes Safety Evaluation of Cohort II for Concussion Drug

Retrieved on: 
Wednesday, June 29, 2022
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Data from Cohort II indicates that the drug was safe and well-tolerated.

Key Points: 
  • Data from Cohort II indicates that the drug was safe and well-tolerated.
  • Cohort II was unblinded and evaluated by the Safety Review Committee.
  • Cohort II included six healthy human volunteers who received one dose of PRV-002 or placebo followed by evaluations for abnormal responses.
  • After reviewing the data from Cohort II, I have strong confidence that PRV-002 will continue to show safety for this Phase I clinical trial as an option for the treatment of concussion.

NeuroTrauma Sciences Presents Update on Neuroprotective Compounds NTS-104 and NTS-105 at the 12th Annual Traumatic Brain Injury Conference

Retrieved on: 
Tuesday, June 7, 2022
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ATLANTA, June 7, 2022 /PRNewswire/ -- NeuroTrauma Sciences, LLC (NTS), a private biopharmaceutical company developing a portfolio of disease-modifying therapeutic candidates to treat the devastating effects of traumatic brain injury (TBI), today provided an update on the development of its lead drug candidates NTS-104 and NTS-105 in traumatic brain injury.

Key Points: 
  • ATLANTA, June 7, 2022 /PRNewswire/ -- NeuroTrauma Sciences, LLC (NTS), a private biopharmaceutical company developing a portfolio of disease-modifying therapeutic candidates to treat the devastating effects of traumatic brain injury (TBI), today provided an update on the development of its lead drug candidates NTS-104 and NTS-105 in traumatic brain injury.
  • Tom J. Parry, Ph.D., MBA, Chief Science Officer, presented recent results during an oral session at the 12th Annual Traumatic Brain Injury Conference held in Washington, DC.
  • NTS-105 rapidly enters the brain at concentrations sufficient to modulate key target receptors, protecting neurons from inflammation, ischemia and programmed cell death.
  • NeuroTrauma Sciences (NTS) is a biopharmaceutical company advancing its mission to address the range of deficits caused by stroke and traumatic brain injury.

Odyssey Health, Inc. Completes Safety Evaluation of Cohort I for Concussion Drug

Retrieved on: 
Wednesday, June 1, 2022
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Odysseys trial involves administering PRV-002, the Companys novel drug to treat concussion, to healthy human subjects.

Key Points: 
  • Odysseys trial involves administering PRV-002, the Companys novel drug to treat concussion, to healthy human subjects.
  • Cohort I was unblinded and evaluated by the Safety Review Committee.
  • Cohort I included eight healthy human volunteers that received one dose of PRV-002 or placebo followed by evaluations for abnormal responses.
  • Jacob VanLandingham, Ph.D., VP of Drug Development for Odyssey Health, commented, PRV-002 appears to be well-tolerated when given intranasally.

Odyssey Health, Inc. Announces Positive Results from Initial Phase I Clinical Trial Subjects for Concussion Drug

Retrieved on: 
Thursday, May 5, 2022
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Odysseys trial is administering PRV-002, their novel drug to treat concussion, to healthy human subjects.

Key Points: 
  • Odysseys trial is administering PRV-002, their novel drug to treat concussion, to healthy human subjects.
  • Based on our animal data and after reviewing our initial Phase I trial safety reports we are optimistic that PRV-002 will be a safe option for the treatment of concussion.
  • We look forward to completing the Phase I trial and presenting our findings to the FDA.
  • Following FDA review we intend to initiate a Phase II clinical trial in the US starting with our military.