Zylorion Receives Approval for Phase II Clinical Study for its Proprietary Almond Therapy™

First of its kind study to investigate the effects of Almond Therapy in TRD patients receiving intranasal esketamine.

CALGARY, AB, May 10, 2022 /PRNewswire/ -  PsiloTec Health Solutions Inc., operating as Zylorion Health, ("Zylorion" or the "Company"), a mental health care and psychedelic therapy focused innovator, is pleased to announce it has received approval from the Health Research Ethics Board of Alberta (the "HREBA") to conduct a phase II clinical study for patients suffering from treatment-resistant depression ("TRD").

Approximately 320 million people globally suffer from major depressive disorder ("MDD"). Of this population, roughly one-third do not respond to conventional antidepressants, a condition known as treatment-resistant depression.   

The first of its kind, single-blind, randomized, controlled, phase II clinical study will look at clinical outcomes of 102 patients suffering from TRD. The study participants will be observed in two groups. The first group will undergo treatment receiving standard and approved intranasal esketamine ("Spravato"). The second group will undergo treatment receiving both Spravato and Zylorion's proprietary multi modal therapy, Almond Therapy.      

The primary outcome of the clinical study will be to determine if augmentation with Almond Therapy leads to better patient outcomes, as assessed using the Montgomery-Asberg Depression Rating Scale ("MADRS"), a standardized interview measure for depression.

"This marks a very important milestone for Zylorion and for Almond Therapy. While new psychedelic compounds bring hope for the roughly one billion people around the world suffering from mental illness, we strongly believe that these powerful compounds should be administered in combination with appropriate therapy, for both the safety of the patient and to achieve the best clinical and sustainable outcomes," commented Dr. Peter Silverstone, Chief Executive Officer. "We are committed to taking an evidence-based approach to achieving our goal of improved patient outcomes, and this clinical trial is a pivotal step to demonstrating the incremental efficacy of Almond Therapy." 

The clinical study is expected to begin in Q2 2022 and is anticipated to finish recruitment in the next 12 to 18 months. The study will adhere to International Conference on Harmonization ("ICH") guidelines for Good Clinical Practice ("GCP"), as well as local regulatory requirements. 

Almond Therapy is a proprietary intensive multi modal therapy program that is specifically designed to be delivered in combination with psychedelic drug treatment. Almond Therapy takes a blended approach to therapy delivery and utilizes elements of multiple evidence-based programs. 

Zylorion is a biopharmaceutical company engaged in the development and delivery of integrated mental health therapies to address psychological and neurological mental health conditions. Zylorion is focused on the research, development and commercialization of psychedelic-based compounds, coupled with novel therapeutic treatment programs targeting a continuum of mental health conditions, such as MDD (major depressive disorder), TRD (treatment resistant depression), PTSD (post-traumatic stress disorder), general depression, anxiety disorders, and a number of addictive tendencies. Zylorion aims to leverage leading technologies to support the scalability and accessibility of its integrated therapy programs in its mission to enable those experiencing mental health challenges to thrive.

This news release contains statements that constitute forward-looking information ("forward-looking information") within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as "expects", or "does not expect", "is expected", "anticipates" or "does not anticipate", "plans", "budget", "scheduled", "forecasts", "estimates", "believes" or "intends" or variations of such words and phrases or stating that certain actions, events or results "may" or "could", "would", "might" or "will" be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information.

SOURCE Zylorion