Israeli biopharmaceutical company Short Wave Pharma has announced that it has signed a clinical trial agreement with the Sheba Fund for Health Services and Research to study the safety and feasibility of psilocybin-assisted psychotherapy for the treatment of ‘anorexia nervosa.
Short Wave Pharma, which develops patent-pending psychedelic compositions and delivery methods, signed the agreement with the Sheba Fund and with Dr. food and Yoel Golbert, co-researcher at the center.
An open-label, investigator-initiated phase II study of psilocybin-assisted psychotherapy for anorexia nervosa will be conducted with Short Wave as the exclusive commercial partner. The trial, the first of its kind in Israel, recently gained approval from the Israeli Ministry of Health and is preparing to recruit participants.
“We are honored to partner with Dr. Gur, Mr. Golbert and the Sheba Center for Eating Disorders in this important study,” said Rivki Stern, CEO of Short Wave. “Anorexia nervosa is a devastating and complex, life-changing disease of patients, primarily women and girls, and their families. Psychedelics present a new paradigm in mental health care, with the potential to have a positive impact on some facets of this disease The new psilocybin formulation and oral film of Short Wave have been developed to further broaden the mechanism of action and address other facets of the disease, bringing us closer to a solution .”
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.
Short Wave’s patent-pending psilocybin formulation is designed to affect multiple receptors that play a role in anorexia nervosa through an expanded mechanism of action, and its proprietary buccal delivery method directly attacks metabolic challenges and eliminates patient burden in this vulnerable population. Together, they provide a cost-effective approach to treating this complex condition.
Short Wave Pharma develops new formulations of psilocybin and additional APIs, as well as personalized delivery methods, to provide significant additional benefits to patients with mental health disorders, neurodegenerative diseases, chronic pain and potentially all other medical conditions where psilocybin is known to have a positive effect. The Sheba Center for Eating Disorders 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 mental illness, binge eating disorder, atypical anorexia and more.