Wesana Health Holdings, Inc. (OTCQB: WSNAF) (CSE: WESA) is engaged as a life sciences company, which is focused on the research and development of novel therapies using psilocybin, CBD, and more to treat brain injuries. Shares of the psilocybin life sciences company are soaring 79% through early trading on Monday, March 14, 2022. Over the past thirty days, Wesana Health has seen average daily volume of 19,241 shares on its OTCQB listing. However, volume of 335,623 shares or dollar volume of $342,335, has already exchanged hands through early trading.
Shares of Wesana Health are surging after the company announced that it has received positive feedback from the U.S. Food and Drug Administration (FDA) regarding their pre-IND (investigational new drug) meeting for SANA-013 and the treatment of Traumatic Brain Injury (TBI) related major depressive disorder (MDD). Wesana Health received the formal letter from the FDA on March 11th, which provides requirements needed to begin clinical studies for the drug candidate.
Wesana Health says the FDA’s response provides a framework for IND-enabling studies and further validates the early hard-work on SANA-013. As a result, the company estimates beginning in-human clinical trials sometime in late 2022.
SANA-013 is a novel combination therapy that utilizes a loading dose of psilocybin and a maintenance dose of psilocybin given with a dose of cannabidiol (CBD). Wesana Health says the novel treatment is an alternative to clinic-administered large doses of psilocybin, which have shown poor durability and weakened effectiveness over time. SANA-013 is instead being developed as a loading dose, followed by self-administered maintenance doses to ensure sustained benefits 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.”
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