Wesana Health Holdings Inc. (OTCQB:WSNAF) (CSE:WESA) have received a full written response from the Food and Drug Administration regarding their pre-investigational new drug meeting for the novel therapy and proprietary protocol of SANA-013 for the treatment of traumatic brain injury related major depressive disorder.
The company received positive written responses from the FDA on March 11th outlining the requirements to open the IND and commence with clinical studies for SANA-013. The company believes the written response provides a path to agreements on IND-enabling studies and validates the team’s effort and accomplishments over the past year. Wesana intends to initiate its in-human clinical study program in late 2022. The FDA response also provided important insights pertaining to advancing SANA-013 as a potential treatment for TBI-related MDD.
Mark A. Wingertzahn, Wesana’s chief ccientific officer stated: “We are highly appreciative of the clear direction FDA has given us in terms of what will be required to advance SANA-013. We look forward to commencing our clinical development program with their feedback in mind and in full compliance with FDA drug development guidelines.”
SANA-013 is covered under patent applications owned by Wesana and directed to novel composition and novel methods of use. Patent applications detail the use of a loading dose of psilocybin and a maintenance dose of psilocybin given concomitantly with a dose of CBD. This novel combination therapy has demonstrated effectiveness through different and potentially complementary pharmacologic pathways. Unlike therapist assisted, single dose therapy, where a large dose of psilocybin is administered in clinic, which has exhibited poor durability and waning effects beginning as early as a few weeks post administration, SANA-013 is being developed to utilize a loading dose of psilocybin followed by self-administered maintenance doses of psilocybin and CBD to provide more sustained effects and benefit over time.
“We were pleased with the feedback from the FDA regarding SANA-013,” said Wesana founder and CEO, Daniel Carcillo. “This is the most important work of my lifetime, and I’m truly excited about the successful completion of this engagement and the clarity of guidance provided by the FDA as we move toward our next phase of development for SANA-013.”
Photo: Courtesy of Marco Allegretti on Unsplash
