Biopharmaceutical company Short Wave Pharma Inc. has announced a signed Clinical Trial Agreement with the Sheba Fund for Health Services and Research.
Dr. Eitan Gur, Principal Investigator and Head of the Sheba Medical Center Department for Eating Disorders along with Mr. Yoel Golbert, Co–Investigator at the Center are partners in the new agreement with Short Wave Pharma who are currently working to develop patent pending psychedelic compositions and methods of delivery.
Under the Agreement, Short Wave will be the exclusive commercial partner for an investigator-initiated, open-label, phase II study of psilocybin-assisted psychotherapy for the treatment of anorexia nervosa.
The clinical trial is the first of its kind and recently obtained approval from the Israeli Ministry of Health. The organizations will now begin to prepare for recruitment.
Through its financial support of the trial, Short Wave Pharma will gain access to crucial trial data and first right of refusal to commercialize any intellectual property generated.
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.
Treating Anorexia with Psilocybin
Anorexia nervosa is a fatal illness that affects between 0.5 and 1% of the population, with rates varying worldwide. Anorexia is one of the most common mental illnesses in the United States and other developed countries.
Anorexia is a serious mental health condition, characterized by abnormal eating behavior and malnutrition. It has an estimated 5-18 percent incidence of mortality and a significant risk of suicide, especially in adolescent girls. It’s a persistent illness with no approved pharmacological therapy available.
Shortwave’s patent-pending 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.
About Short Wave Pharma
Short Wave Pharma Inc. is an Israeli-based biopharmaceutical company that is developing innovative psilocybin and other drug formulations, as well as bespoke delivery methods, to enhance the effects of psilocybin for patients suffering from mental health problems, neurodegenerative diseases, chronic pain, and possibly all other medical situations where it has been demonstrated to be beneficial.
The firm has started preclinical studies for its anorexia nervosa drug and expects to be ready for phase I/IIa trials in Q2 2023, with future development of new formulations and delivery methods for chronic pain and neurodegenerative diseases.
The leadership team at Short Wave is made up of experts in drug development and clinical research, as well as accelerated regulatory processes and pharmaceutical industry know-how.
The Center for Eating Disorders at The Sheba Medical Center
The Center for Eating Disorders is Israel’s largest eating disorder treatment center, and it treats patients over 18 years old with any type of anorexia nervosa, bulimia nervosa, binge eating disorder, a-typical anorexia, or other eating disorders.
The center has acute care units, inpatient and outpatient centers, as well as a treatment program for persistent patients featuring a multi-disciplinary team of physicians, dietitians, psychologists, social workers, movement therapists, drama and art therapists, and fitness professionals.
The aim is to satisfy the demand for safe and effective innovative therapies.