Xpira Pharmaceuticals Inc. Receives FDA Approval For Psilocybin Trial IND Application

TORONTO, Sept. 20, 2022 /PRNewswire/ - Xpira Pharmaceuticals ("Xpira" or "the Company"), a leading developer of next-generation psychedelic medicines for the treatment of eating disorders, is pleased to announce has obtained approval from the United States Food and Drug Administration ("FDA") for its first Investigational New Drug ("IND") application. The Company will initiate a Phase 2a clinical trial which will study the efficacy of psilocybin-assisted therapeutic protocols in patients suffering from Anorexia Nervosa ("AN").

Anorexia nervosa is among the deadliest mental illnesses known to psychiatric medicine, for which there is currently no approved treatment regimen, neither pharmacologic nor psychotherapeutic. With this trial, Xpira aims to contribute to the successful outcome of treatment for patients with AN, including enhancing patients' quality of life by furthering the development of its innovative psilocybin-assisted treatment.

"Throughout my career as a psychiatrist, I have participated in many high-profile pharmacological trials in AN, all of which failed to meet their objectives," said Dr. Allan Kaplan, Xpira's Vice President of Clinical Development.

Because of what we now know of its neurobiology, and the mechanism of action of psilocybin on brain circuitry, I believe that AN could be potentially successfully treated with psilocybin, when utilized and overseen properly within the parameters of psychedelic-assisted psychotherapy. With clear clinical endpoints and a robust study design, and taking into full account the vulnerability of AN patients, we hope to move closer to a treatment that will both improve the prognosis of sufferers and bring us closer to a more complete understanding of this pervasive and difficult to treat condition," Dr. Kaplan added.

This critical regulatory approval from the FDA reinforces Xpira's commitment towards improved clinical outcomes for patients suffering from eating disorders.

Since its inception, Xpira has worked to ensure a safe and effective trial design, leading to a higher standard of care for patients while providing value for its shareholders. With this trial progressing, Xpira has moved to establish a clear differentiation for itself through its clinical expertise and pursuit of specific indications in both the growing market for psychedelic therapeutics and the landscape of pharmaceutical companies committed to the development of treatments for eating disorders.

About Xpira

Xpira Pharmaceuticals Inc ("Xpira") is positioned to be a global leader in development, production and marketing of psychedelic-based medicines with clinically proven efficacy. Our mission is to have a meaningful impact on the lives of patients suffering from mental conditions by developing high quality proprietary therapeutic treatments with a special focus on Eating Disorders.

Xpira's team is composed of industry leaders in North America and the Netherlands, with substantial experience in eating disorders, drug development, intellectual property ("IP"), registration, product commercialization and Specialty Pharma.

Dr. Allan Kaplan —  Vice President, Clinical Development

In addition to his work with Xpira, Dr. Kaplan is a Senior Clinician at the Center for Addiction and Mental Health in Toronto, as well as a Professor in the Department of Psychiatry at the University of Toronto's Temerty Faculty of Medicine. He has worked in the field of eating disorders for 35 years, has lectured widely on various topics in the field, published 200 peer reviewed articles, two books, 60 book chapters and over 200 abstracts. He has held the position of President for both the Academy for Eating Disorders, the largest organization of eating disorder professionals in the world, and the International Eating Disorder Research Society.

CEO and Director — Vanesa Fernandez, Ph.D   

Vanesa Fernandez has over 20 years of experience in various C-level positions and is co-founder of several companies in Europe and North America in the pharma and consumer products sectors. Ms. Fernandez provides Xpira with profound knowledge in product development, clinical programs, regulatory affairs, as well as expertise in licensing, patents, external financing and working in a complex governance structure. Ms. Fernandez is the former CEO of Echo Pharmaceuticals BV ("Echo"), a pioneering firm in the regulated cannabis industry that under her lead grew from a start-up to a mature business, securing Series B investment and raised over EUR 10M of non-dilutive funds. Ms. Fernandez has a Ph.D. in chemistry, is the author of several scientific publications and is the named inventor of more than 10 patents for novel formulations.

President and Director — Nick Wong

Nick Wong is an IP lawyer with over 20 years of experience in the pharmaceutical industry, in the areas of legal, regulatory and scientific R&D. Mr. Wong was selected by his peers for inclusion in the 2022 and 2023 Edition of The Best Lawyers of the Year in Canada for his expertise in IP law and biotechnology law. He has also been recognized internationally in IAM Patent 1000 as a leading lawyer in IP transactions. His existing legal practice combines extensive experience in strategic IP portfolio development and IP litigation, with an expertise in business development (drug development and life cycle-management) and negotiating product development agreements for clients in the areas of pharmaceuticals and other health sciences.

Board of Directors

Xpira's Board of Directors is a experienced group of healthcare entrepreneurs and executives including; Jaiveer Singh, CEO of Mint Pharmaceuticals; Steve Ottaway, CEO of Hyperion Capital Inc. and former Head of Healthcare at GMP Securities L.P. ("GMP"); Dr. Par Nijhawan, Chief Executive Officer of Edesa Biotech Inc. and the former founder and CEO of Medical Futures Inc.; Gregory Gubitz, founding Chief Executive Officer of HLS Therapeutics Inc. and the former Senior Vice President, Corporate Development and General Counsel of Biovail Corporation.

SOURCE Xpira Pharmaceuticals