Enveric Biosciences and University of Calgary Collaborate on a Groundbreaking Clinical Trial for EVM-101 in Cancer Related Distress

Clinical trial aim is to include the identification and characterization of the Cancer Related Distress symptoms most responsive to psychedelic-associated therapy

NAPLES, Fla., Feb. 17, 2022 /PRNewswire/ - Enveric Biosciences (NASDAQ: ENVB)("Enveric" or the "Company), a cutting-edge neuroscience company developing next-generation, psychedelic-inspired mental health medicines, is working with the University of Calgary's Hotchkiss Brain Institute ("HBI"), a leading neurosciences center of excellence, at the Cumming School of Medicine in Calgary, Canada that is dedicated to advancing brain and mental health research and education, to establish a groundbreaking clinical trial of EVM-101 for the treatment of Cancer Related Distress ("CRD").

Approximately 50% of cancer patients report clinical levels of psychological distress having depressed mood, anxiety, demoralization, stress-induced clinical manifestations, and reduced quality of life¹. Up to 40% of cancer patients meet the criteria for a mood disorder requiring treatment². CRD is a significant unmet medical need with no current regulatory approval of pharmacotherapies and an urgent need to optimize the current standard of care for patients with cancer.³

A clinical trial, expected to launch later this year, of EVM-101, a first-generation psychedelic treatment, for CRD will be led by HBI researcher, Dr. Valerie Taylor, Head of the Department of Psychiatry, in Calgary, Canada.  

"We are excited to collaborate with Enveric to study next-generation medicines that we hope will help people cope with the mental health challenges of a cancer diagnosis.  This work will allow us to mobilize our combined resources to research options for cancer patients living with CRD," says Dr. Valerie Taylor.

The EVM-101 study will directly assess the core features of CRD that are most affected and amenable to improvement following a psilocybin-based treatment.

"With the rising rates of cancer and its associated psychological ailments that have been underestimated and underdiagnosed until recently, we are working hard to develop new treatments that help cancer patients suffering from CRD" said Dr. Bob Dagher, Enveric's Chief Medical Officer. "Our collaboration with the research team at the University of Calgary's Hotchkiss Brain Institute and IMPACT Clinical Trial Accelerator will help us to demonstrate the potential benefits of these novel treatments and get them to market as quickly as possible."

A regulatory submission to Health Canada is expected to soon be finalized. Patient enrollment in the clinical trial is expected to begin late in 2022 or early in 2023. The study design will employ proprietary psychiatry and psychotherapy-focused treatments for cancer patients with CRD. Patients will receive a single oral dose of EVM-101 in a supportive environment with psychotherapy to improve outcomes.

Enveric is committed to discovering and developing more effective treatments for cancer patients living with psychological distress and is currently working on three classes of new medicines: EVM-101, a first-generation oral psilocybin; EVM-201, a second-generation pro-drug; and EVM-301, a third-generation psychedelic-inspired and optimized new molecule.

References:

1. Mehnert, A., Hartung, T. J., Friedrich, M., Vehling, S., Brahler, E., Harter, M., et al. (2018). One in two cancer patients is significantly distressed: prevalence and indicators of distress. Psychooncology 27, 75–82. Doi: 10.1002/pon.4464
2. Holland et al. (2013). Distress Management. J Natl Compr Cancer Network 2013 Feb 1;11(2):190-209. doi: 10.6004/jnccn.2013.0027
3. Peters, L., Brederecke, J., Franzke, A., Zwaan, M., Zimmermann, T. (2020). Psychological Distress in a Sample of Inpatients with Mixed Cancer—A Cross-Sectional Study of Routine Clinical Data. Front Psychol. 2020 Nov 30; 11:591771. doi: 10.3389/fpsyg.2020.591771

About Enveric Biosciences   
Enveric Biosciences (NASDAQ: ENVB) is a cutting-edge neuroscience company developing next-generation psychedelic-inspired mental health medicines. Enveric's robust pipeline supports drug development from the clinic to commercialization for millions of patients in need around the world suffering from conditions that include cancer-related distress, PTSD, and more. For more information, please visit www.enveric.com.

About Hotchkiss Brain Institute
The Hotchkiss Brain Institute is an internationally recognized center of excellence in brain and mental health research and education, based at the University of Calgary's Cumming School of Medicine. The Hotchkiss Brain Institute was launched in October 2004 by a foundational gift from Calgary's own Hotchkiss family, the late Harley Hotchkiss, well-known entrepreneur, supporter of neuroscience research, and key founder of the Calgary Flames. The Institute is devoted to understanding the mechanisms and impact of brain injury, disease, disorders and mental health. Today the HBI is composed of nearly 1400 people, including over 220 members spanning 12 academic departments and nine faculties at the University of Calgary, all working towards a shared vision: Healthy Brains for Better Lives. www.hbi.ucalgary.ca

About IMPACT Clinical Trials Accelerator
IMPACT is a program for new ventures in the life sciences or biomedical industries who are seeking guidance in conducting clinical trials to secure regulatory approval for their new health-related inventions. IMPACT disrupts traditional healthcare innovation by accelerating marketing approval via a tailored evidence collection and regulatory framework. research.ucalgary.ca/innovation/ecosystem/impact-clinical-trials-accelerator

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SOURCE Enveric Biosciences