Clinical Trials Of Psilocybin Treatment For Overeating Disorder Are Ready, Here's What Results Show So Far

Tryp Therapeutics Inc. TRYPF is a clinical-stage biotech company focused on developing psilocybin-based compounds for ill-treated diseases. Together with the University of Florida, the company is currently studying the effects of psilocybin administration on people who suffer from Binge Eating Disorder, a condition for which no treatment has yet proven effective. 

Also known as BED, this health condition is characterized by recurring episodes of eating large quantities of food and feeling unable to stop. According to the company, up to 3.5% of females and 2.0% of males will develop this disorder at some point in their lives, which translates to nearly 4 million women and 2 million men in the U.S. 

The Results

Tryp announced today the initial data readout for the first patient dosed in its Phase II S.T.O.P. (Study of the Treatment of Overeating utilizing Psilocybin) trial. The STOP trial stands as the first use of psilocybin in conjunction with psychotherapy as a therapeutic intervention in patients with BED.

Immediately after the post-dosing integration session with psychotherapists and persisting throughout the four-week time period post-dosing, the first patient in the STOP trial exhibited reduced overall anxiety; reduced anxiety around food; reduced compulsion to overeat and improved self-image and confidence. 

As a result, the patient also lost significant weight. According to the company’s public statements, these behavioral improvements are consistent with those described in other clinical studies on the benefit of psilocybin as a therapeutic intervention in mental disorders. 

Regarding adverse effects on the patient’s health during the same 4-week period after receiving the psilocybin doses, none were reported. Nevertheless, the STOP trial protocol calls for patients’ monitoring for an additional eight weeks post-dosing, which would then confirm, change or refute the initial findings.

"While we are mindful to not draw too many conclusions from the first patient at four weeks, we are excited with the results to date and look forward to the potential replication of these results in additional patients," said Jim Gilligan, Tryp's Interim CEO and chief scientific officer. "Based on our understanding of psychotherapy in BED patients and our discussions with our colleagues at the University of Florida, we believe that the improvements witnessed in this patient following a single intervention with TRP-8802 in combination with tailored psychotherapy are on par with what might be possible in 12 months of extensive psychotherapy alone."

Tryp’s Proprietary Psilocybin

TRP-8802 is the predecessor to the company's lead psilocybin-based drug candidate, TRP-8803. TRP-8803 has a unique formulation and delivery system and is designed to enhance the positive effects of psilocybin and psilocybin-related compounds in treating binge eating, chronic pain and other indications. 

The company is currently utilizing its TRP-8802 to evaluate the use of psilocybin-related compounds in certain neuropsychiatric disorders in early-stage trials. If initial efficacy is shown, TRP-8803 will be studied in future trials.

What’s more, besides its ongoing Phase II trial for the treatment of binge eating disorder, Tryp has announced an upcoming Phase IIa clinical trial with the University of Michigan to evaluate TRP-8802 for fibromyalgia. 

Photo Courtesy of Jill Wellington on Pexels.