Tryp Therapeutics has reached a breakthrough after spending several months working to submit an Investigation New Drug (IND) proposal to the U.S. FDA. TRP-8802, Tryp Therapeutics’ candidate, will be evaluated for its ability to treat eating disorders. Tryp hopes to begin its Phase 2a clinical research toward the end of 2021, assuming it is approved.
Substantial changes to normal, healthy eating behaviors are defined as an eating disorder. A major symptom of most eating disorders is the inability to control impulses, which contribute to weight gain. As a result, scientists believe the mental state of the person has a direct effect on the disorder.
Aside from obesity, eating disorders disrupt metabolism which can lead to metabolic disorders. Additionally, certain psychiatric conditions have been linked to eating disorders. TRYP is currently researching binge eating disorder (BED), Prader-Willi syndrome (PWS), and hypothalamic obesity (HO).
Defined as eating enormous amounts of food in a short period of time, binge eating causes significant guilt and anxiety. Psychotherapy is the current method of treatment, which may include lisdexamfetamine dimesylate (Vyvanse). This medicine is used for treating serious binge eating disorders and is the first of its kind to be approved by the FDA.
However, because it is considered an amphetamine, it has the potential to stimulate addiction. Like other amphetamines, those that use Vyvanse for a long period of time have an increased risk of overdosing, which is often fatal. Additionally, long-term users may experience psychosis, increased blood pressure, or even more permanent effects of strokes or heart attacks.
Scientists believe a damaged hypothalamus can cause a person’s weight to increase, leading to hypothalamic obesity. Located in the brain, the hypothalamus helps to control appetite and weight, along with several other important roles. It is believed that psilocybin has the ability to heal this structure by stimulating neuroplasticity.
For TRYP to complete the IND proposal, several hurdles had to be jumped, including securing its lead investigator, Dr. Jennifer Miller, pediatric endocrinology Professor at the University of Florida and expert in the treatment of rare eating disorders. Psychotherapeutic training via Fluence was necessary for the clinical trial, as well as the collaboration with Clinlogix to approve the Psilocybin-for-Neuropsychiatric (PFN) Disorders program. The University of Michigan agreed to facilitate the reserach for Tryp’s PFN program.
Finally, Tryp Therapeutics appointed new member Daniel Clauw, M.D. to its Scientific Advisory Board (SAB), with Robin Carhart-Harris, Ph.D. as the newly appointed chairman. Dr. Carhart-Harris is the Head of the Divison of Brain Sciences at the Center for Psychedelic Research at the Imperial College of London. She is also the director of the Neuroscape Psychedelic Division at the University of California, San Francisco.
The Phase 2a clinical trial will test the efficacy of Tryp Therapeutic’s synthetic form of psilocybin, TRP-8802. Upon approval by the FDA, the drug will be tested along with psychotherapy as a possible treatment for eating disorders. This proposal, which is the first of many to come, is a huge accomplishment for Tryp Therapeutics.