Emerging life sciences company specializing in development and delivery of psychedelic and naturally extracted therapies to treat traumatic brain injuries Wesana Health Holdings Inc. (CSE: WESA) (OTCQB: WSNAF) announced having been granted a pre- IND (Investigational New Drug) meeting by the U.S Food and Drug Administration (FDA) to discuss the novel therapy and proprietary of SANA-013 for the treatment of traumatic brain injuries (TBI) related major depressive disorder (MDD).
The company is looking forward to this meeting with aim of receiving a feedback from FDA on its toxicology program and research to-date before clearance and initiation of the phase 1 clinical trial which is expected to take place later in the year.
The company’s founder and chief executive officer, Daniel Carcillo, says this development marks a credible millstone for the company and also for people suffering from TBI related depression.
“This is a thrilling milestone in my nearly-decade long effort to find and advocate for treatments that provide hope to brain injury survivors. People who are suffering with severe TBI-related depression have a fivefold increase in suicide attempts and are 3 to 4 times more likely to die by suicide1 2. They deserve to have the best diagnostics and treatment options available to them, including a pharmaceutical option that doesn’t exasperate symptomology. We look forward to being able to move SANA-013 to a Phase I clinical trial as soon as possible,” said the CEO.
Currently, there are multiple available therapies for depression however, the success rate of antidepressant is approximately 30% to 40% which begs for introduction of additional therapeutic options.
Despite the existence of therapies for treating depression, only 44% of TBI patients with MDD receive antidepressants or counseling. Among the treated ones, there is very little evidence supporting the efficacy of antidepressants in the treatment of post-TBI depression.