U.S. Provisional Patent Application entitled “Device and Method for the Treatment of Traumatic Brain Injuries and Post-Traumatic Stress Disorder” Serial No.: 63/016,455 Filing Date: April 28, 2020
U.S. Provisional Patent Application entitled “Methods and Compositions for Treating Post Traumatic Stress Disorder or Mild Traumatic Brain Injury with Post Traumatic Stress Disorder” Serial No.: 63/012,435 Filing Date: April 20, 2020
Stage 1: Pre-Clinical Studies
Eleusian’s development program begins with basic science investigations to demonstrate safety and efficacy of the combination of Psilocybin and NAC in treating mild traumatic brain injury (mTBI) with PTSD or PTSD alone in established rodent models.
Stage 2: IND-enabling Pre-clinical Studies
Following successful demonstration of safety and efficacy of the combination of Psilocybin and NAC in the treatment of mTBI with PTSD or PTSD alone, Eleusian plans to conduct pre-clinical studies (including GLP toxicology, ADME, as well as formulation and manufacturing development) necessary to file an Investigational New Drug (IND) application.
Stage 3: Human Clinical Trials
Following regulatory approval of our IND, Eleusian plans to initiate human clinical trials of the combination of Psilocybin and NAC in the treatment of mTBI with PTSD or PTSD alone in collaboration with investigators at the University of Miami and other leading clinical research institutions.
Eleusian Biosciences Corp. in collaboration with multiple university research institutes intends to prove that clinical and physiological effectiveness in post concussion syndrome and PTSD are enhanced by timely measured dosages of Psilocybin+NAC with superior clinical results as measured by objective outcomes.
We expect this combination to elicit clinical outcomes that are superior to Psilocybin or NAC alone.