Under the Agreement, Shortwave will be the exclusive commercial partner in an investigator-initiated, open-label, phase II study of the safety and feasibility of psilocybin-assisted psychotherapy for the treatment of anorexia nervosa (the "Trial").
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's data as well as a first right of refusal to commercialize any intellectual property generated from the Trial. 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 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 SHORTWAVE
Short Wave Pharma Inc. is an Israeli based biopharmaceutical company developing novel formulations of psilocybin and additional APIs, as well as customized delivery methods, to effect significant additional benefits for patients suffering from mental health disorders, neurodegenerative diseases, chronic pain, and potentially all other medical conditions where psilocybin is known to have a positive effect.
The Company has begun pre-clinical studies related to its anorexia nervosa product and plans to be ready for phase I/IIa trials in Q2 2023. Shortwave's leadership team combines years of experience in drug development and clinical research, accelerated regulatory pathways and pharmaceutical industry expertise. The Company's future programs include development of novel formulations and delivery approaches for chronic pain and neuro degenerative diseases.
ABOUT THE CENTER FOR EATING DISORDERS AT THE SHEBA MEDICAL CENTER
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, a-typical 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.
As Israel's top facility for treating eating disorders, it strives to address the need for safe and effective novel treatments.
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For further information please contact:
Rivki Stern, CEO [email protected]
Yoel Golbert, Co–Investigator [email protected]
SOURCE Short Wave Pharma Inc.
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