Short Wave Pharma Inc., a biopharma company developing patent pending psychedelic compositions and methods of delivery, has signed a clinical trial agreement with the Sheba Fund for Health Services and Research and with Eitan Gur, principal investigator and head of the Sheba Medical Center Department for Eating Disorders, and Yoel Golbert, co–investigator at the center.
Under the agreement, Shortwave will be the exclusive commercial partner in an investigator-initiated, open-label, phase II clinical trial 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 obtained approval from the Israeli Ministry of Health and is preparing for participant recruitment.
In recognition of its financial support for the trial, the company will gain 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 to positively consider a follow-on study by the fund and the center using the company’s psilocybin-based formulation and buccal film delivery system.
Anorexia nervosa is a life-threatening disease and a severe eating disorder that affects about 0.5-1% of the population. Of all psychiatric disorders, anorexia is a leading cause of disability in the U.S. and many other developed countries.
When left untreated, anorexia can lead to severe distress, significant psychological dysfunction and even death at a 5-18% incidence with a high risk of suicide. It is a chronic disease with no approved pharmacological treatment.
Shortwave’s psilocybin-based formulation is designed to affect several receptors which play a part in anorexia nervosa through an expanded mechanism of action, and its proprietary buccal method of administration directly addresses metabolism related challenges and eliminates patient burden in this vulnerable population. Together, they constitute a cost-efficient approach for treating this complex condition.
Short Wave Pharma is an Israel-based biopharmaceutical company developing novel formulations of psilocybin and additional APIs, as well as customized delivery methods, for patients suffering from mental health disorders, neurodegenerative diseases, chronic pain, and potentially other medical conditions where psilocybin is known to have a positive effect.
The company has started pre-clinical studies related to its anorexia nervosa product and plans to be ready for phase I/IIa trials in Q2 2023.
About the Sheba Medical Center Department for Eating Disorders
The Center for Eating Disorders is the largest center of its kind in Israel and provides care for patients over 18 years old dealing with eating disorders of various severity including anorexia nervosa, bulimia nervosa, binge eating disorder, atypical anorexia and more.
The center includes acute care units, inpatient and outpatient facilities along with a program for chronic and treatment resistant patients. It employs a multi- disciplinary staff including physicians, clinical dietitians, psychologists, social workers, movement, drama and art therapists and fitness professionals.