Wesana Health Holdings Inc. announced that the U.S Food and Drug Administration (U.S. FDA) granted the company's request for a pre-IND (Investigational New Drug) meeting to discuss the novel therapy and proprietary protocol of SANA-013 for the treatment of Traumatic Brain Injury (TBI) related major depressive disorder (MDD). In the pre-IND meeting, the Company expects to receive feedback from the FDA on its toxicology program and research to-date, in advance of IND clearance and initiation of the Phase I clinical trial, currently anticipated to occur in late 2022. While there are a number of available therapies to treat depression, the success rate of antidepressants is only approximately 30 to 40%, highlighting the need for additional therapeutic options3.

Further, despite the established importance of treating depression, only 44% of TBI patients with Major Depressive Disorder (MDD) received antidepressants or counseling4. Of those treated, there is limited evidence supporting the efficacy of antidepressants in the treatment of post-TBI depression. Wesana's drug development program looks to utilize combination therapy to treat migraine and the symptoms associated with TBI, such as depression.

By utilizing psilocybin and cannabidiol (“CBD”), a combination therapy of compounds with demonstrated effectiveness, SANA-013, is targeted to improve neuroplasticity and neurogenesis while acting as an anti-neuroinflammatory. In contrast to 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 utilizes a loading dose of psilocybin followed by self-administered maintenance doses of psilocybin and CBD to provide more sustained effects and benefit over time.