Biotech Company Seeks FDA Approval For Psilocybin-IBS Treatment

Tryp Therapeutics announced on Wednesday that it had “submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its planned Phase 2a clinical trial investigating the effects of psilocybin-assisted psychotherapy in the treatment of patients aged 21+ suffering from Irritable Bowel Syndrome (IBS) at Massachusetts General Hospital (MGH).”

The Canadian company said in the announcement that the “planned open label study in collaboration with Harvard Medical School/Massachusetts General Hospital will evaluate the effect of psilocybin-assisted psychotherapy in patients with treatment-resistant IBS who experience chronic abdominal pain and other debilitating gastrointestinal symptoms.” 

“Many of these patients also suffer from fibromyalgia, anxiety and fatigue. The primary efficacy endpoint of the study will be improvement in abdominal pain. The proposed study will also explore changes in brain connectivity and responses to pain at baseline and at four weeks, six months and twelve months post the psychedelic drug sessions, along with numerous other secondary endpoints,” the announcement said. 

“Tryp and our collaborators at Harvard/MGH believe there is tremendous potential for the treatment of debilitating IBS symptoms by utilizing the combined administration of psilocybin and psychotherapy. The clinical study will examine how psilocybin-assisted psychotherapy may alter brain networks involved in chronic abdominal pain and gastrointestinal-specific anxiety in patients with IBS to improve their symptoms. Submission of IND 163994 is an important step in advancing our program,” said Jim Gilligan, the chief executive officer of Tryp Therapeutics.

Gilligan told Green Market Report that the “most important thing is a clinical data – to be able to not just assume or hypothesize that we’re going to have a benefit, but to actually demonstrate that we can do something positive for patients.

“We’re looking at things a little bit differently than the big guys, looking at unique areas where we can have first-mover advantage. But we’re judicious in selecting areas where we really think that we’ll have a positive outcome,” Gilligan said.

According to Green Market Report, Gilligan “likened the planned administration of psilocin to the work of anesthesiologists.”

“Using an IV to induce and subsequently awaken the patient from the psychedelic state, the approach might also allow for the use of serotonin antagonists to terminate the psychedelic experience, if necessary,” the outlet said, which noted that TRP-8803 will be “central” to the company’s approach to the therapy.

TRP-8803 is “Tryp’s lead program,” the company says, describing it as “a proprietary formulation of IV-infused psilocin (the active metabolite of psilocybin) that alleviates numerous shortcomings of oral psilocybin including: significantly reducing the time to onset of the psychedelic state, controlling the depth and duration of the psychedelic experience, and reducing the overall duration of the intervention to a commercially feasible timeframe.

“The Company has an ongoing Phase 2a clinical trial for the treatment of Binge Eating Disorder at the University of Florida, an upcoming Phase 2a clinical trial with the University of Michigan for the treatment of fibromyalgia and a planned Phase 2a trial for the treatment of irritable bowel syndrome at Mass General Hospital, all of which are utilizing TRP-8802 (synthetic, oral psilocybin) to demonstrate efficacy in these indications. Where a preliminary clinical benefit has been demonstrated, subsequent studies are expected to utilize TRP-8803 (IV-infused psilocin) which has the potential to further improve efficacy, safety and patient experience,” Tryp said in Wednesday’s announcement. 

The post Biotech Company Seeks FDA Approval For Psilocybin-IBS Treatment appeared first on High Times.

Biotech Firm Launches Trial To Study LSD As Treatment For Anxiety

A New York-based biotech firm has begun a clinical trial to study LSD as a treatment for anxiety, announcing last week that it had administered the psychedelic drug to a patient enrolled in the study for the first time. The research is designed to study the effectiveness of MM-120, a pharmaceutically optimized form of lysergic acid diethylamide (LSD) from MindMed, in treating generalized anxiety disorder (GAD).

MindMed is a biopharmaceutical company developing psychedelic therapies to treat mental health disorders. Robert Barrow, the chief executive officer of the company, said that the study is the largest well-controlled clinical trial of LSD ever conducted, adding that the research “represents a major milestone for MindMed and for the many patients suffering from GAD.”

“This exciting next step in the advancement of LSD builds on the positive topline data presented by our partners at University Hospital Basel in May 2022, which demonstrated the rapid, durable, and statistically significant effects of LSD and its potential to safely mitigate symptoms of anxiety and depression,” Barrow said in an August 25 statement from the company. “The results of our phase 2b trial will guide the dose selection and development strategy for our pivotal phase 3 clinical trials, as we continue our efforts to bring a new potential treatment to the millions of people living with GAD.”

GAD is a chronic and sometimes debilitating mental health disorder that affects nearly 6% of U.S. adults at some point in their lives. Symptoms of GAD include excessive anxiety and worry that persists for over six months, which can lead to significant impairments in social, occupational and other functioning, according to the National Institute of Mental Health (NIMH). While there are substantial similarities between GAD, major depressive disorder (MDD) and other serious mental health conditions, research into the disorder has yielded little innovation in treatment over the past several decades.

MindMed’s phase 2b trial is a multi-center, parallel, randomized, double-blind, placebo-controlled, dose-optimization study. Investigators plan to enroll 200 participants who will receive either a single administration of up to 200 micrograms of MM-120 or a placebo. The primary objective is to determine the reduction in anxiety symptoms 4 weeks after a single administration of MM-120, compared across five groups of study participants. Key secondary objectives of the study, measured up to 12 weeks after the single administration, include assessments of safety and tolerability as well as the quality of life.

The Resurgence of LSD Research

The MindMed study is representative of the recent resurgence in research into psychedelic drugs as treatments for serious mental health conditions. Michael Pollan, a journalist and educator who this summer released “How to Change Your Mind,” a Netflix documentary series based on his 2018 book with the same title, notes that researchers studied LSD as a possible treatment for mental health disorders in the 1950s and ‘60s. The tide of opinion turned against the drug only after people began using it recreationally.

“With a powerful assist from Timothy Leary, the flamboyant Harvard psychology professor, psychedelics had escaped the laboratory, falling into the eager arms of the counterculture,” Pollan wrote in the Wall Street Journal in 2018. “Yet in the decade before that there had been 1,000 published studies of LSD, involving 40,000 experimental subjects, and no fewer than six international conferences devoted to what many in the psychiatric community regarded as a wonder drug.”

In 1968, LSD was criminalized in the United States, largely ending research into the drug for decades. But interest in its value as a psychiatric medicine has rebounded. In July of this year, the American Psychiatric Association issued a statement that encouraged continued research into psychedelics as therapies for serious mental health conditions.

“There is currently inadequate scientific evidence for endorsing the use of psychedelics to treat any psychiatric disorder except within the context of approved investigational studies,” the APA wrote in a policy position approved by the professional group’s board of trustees. “APA supports continued research and therapeutic discovery into psychedelic agents with the same scientific integrity and regulatory standards applied to other promising therapies in medicine.”

The post Biotech Firm Launches Trial To Study LSD As Treatment For Anxiety appeared first on High Times.