Short Wave Pharma Inc., a biopharmaceutical company developing patent-pending psychedelic compositions and delivery methods, has signed a clinical trial agreement with the Sheba Fund for Health Services and Research and Researcher Eitan Gur principal and chief of the Sheba Medical Center’s department for Eating Disorders, and Yoel Golbert, co-investigator at the center.
Under the agreement, Shortwave will be the exclusive commercial partner for an open-label, investigator-initiated, Phase II study of the safety and feasibility of psilocybin-assisted psychotherapy for the treatment of anorexia nervosa.
The trial, the first of its kind in Israel, recently gained approval from the Israeli Ministry of Health and is preparing to recruit participants.
In recognition of its financial support of the trial, the company will have access to the trial data as well as a first right of refusal to commercialize any intellectual property generated from it. The parties agree to cooperate in the future and positively consider a follow-up study by the fund and the center using the company’s psilocybin formulation and buccal film delivery system.
Anorexia nervosa is a life-threatening illness and serious eating disorder that affects approximately 0.5-1% of the population. Of all psychiatric disorders, anorexia is the leading cause of disability in the United States and many other developed countries.
When left untreated, anorexia can lead to severe distress, significant psychological dysfunction and even death at an incidence of 5-18% with a high risk of suicide. It is a chronic disease without approved pharmacological treatment.
Shortwave’s psilocybin formulation is designed to affect multiple receptors that play a role in anorexia nervosa through an extensive mechanism of action, and its proprietary oral delivery method directly addresses metabolic challenges and eliminates the patient burden in this vulnerable population. Together, they provide a cost-effective approach to treating this complex condition.
Short Wave Pharma is an Israel-based biopharmaceutical company that develops new formulations of psilocybin and additional APIs, as well as personalized delivery methods, for patients with mental health disorders, neurodegenerative diseases, chronic pain and potentially other medical conditions where psilocybin is known to have a positive effect.
The company has begun preclinical studies related to its anorexia nervosa product and expects to be ready for Phase I/IIa trials in the second quarter of 2023.
About Sheba Medical Center Eating Disorders Service
The Eating Disorders Center is the largest center of its kind in Israel and provides care for patients over the age of 18 with eating disorders of varying severity, including anorexia nervosa, bulimia nervosa, binge eating disorder, atypical anorexia and more.
The center includes acute care units, inpatient and outpatient facilities as well as a program for chronic and treatment-resistant patients. It employs a multidisciplinary staff including physicians, clinical dietitians, psychologists, social workers, movement, theater and art therapists, and fitness professionals.