Tryp Therapeutics Has Completed Psychotherapist Training for a Planned Clinical Trial to Investigate Psilocybin Therapy for IBS

IBS is a common, recurrent, and oftentimes debilitating affliction with an estimated prevalence of between 4-5%. Analytic studies have revealed that numerous patients suffering from IBS and their gastroenterologists are unsatisfied with the current treatments.

MGH and Tryp are collaborating to investigate the efficacy of psilocybin-assisted psychotherapy for individuals aged 21+ suffering from Irritable Bowel Syndrome (IBS). These participants have chronic abdominal pain, fibromyalgia, anxiety, fatigue and other debilitating digestive complications that stem from their condition.

Today, Tryp announced the successful completion of their Phase 2a clinical trial training for psychotherapists at Massachusetts General Hospital. This remarkable undertaking was spearheaded by Fluence, a leader in therapeutic guidance and psychedelic compounds administration, with renowned researchers and experienced therapists directly involved.

TRYP Therapeutics Completes Psychotherapy Training for Planned Phase 2a Clinical Trial at Massachusetts General Hospital

Kelowna Canada, (April 4, 2023) — Tryp Therapeutics, Inc. (CSE: TRYP) (OTCQB: TRYPF) (“Tryp” or the  “Company”), a clinical-stage biotechnology company focused on developing intravenous-infused psilocin  (the active metabolite of psilocybin) for diseases with high unmet medical needs, today announced it has completed the training of psychotherapists 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 training was conducted by Fluence,  which is led by researchers and psychotherapists with direct experience in psychedelic clinical trials and  is the foremost provider of psychotherapeutic training for health professionals that are administering  psychedelic compounds to patients. 

The planned study 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 study will also explore changes in brain connectivity  and responses to pain at baseline, four weeks, six months and twelve months, post-the psychedelic  sessions, along with numerous other secondary endpoints. 

Dr. Franklin King MD, Harvard Professor at the Center for the Neuroscience of Psychedelics, the principal  investigator of the study, said, “Symptoms occurring at the mind-body interface, such as disorders of gut brain interaction, are often inadequately addressed by conventional psychological and somatic therapies  alike. Given promising research suggesting that psychedelics bypass typical medical paradigms, we  believe this is an extraordinarily promising avenue of research with significant potential benefit for  patients.” 

“The progress being made through our collaboration with Tryp Therapeutics shows there is potential for  the treatment of debilitating IBS and other disorders of gut-brain interaction by utilizing the combined  administration of psilocybin and psychotherapy,” added Dr. Erin Mauney, a physician at Massachusetts  General Hospital leading the study. “We are pleased to have completed this training in advance of  commencing the Phase 2a trial.” 

Elizabeth Nielson, Ph.D., Co-Founder and Chief Visionary Officer of Fluence, commented “We’re thrilled  to have the opportunity to work with Tryp Therapeutics and support their pioneering work in clinical  research. It gives one confidence in the future of the field to see the high level of professionalism and  care that’s gone into planning this study at Mass General Hospital. Studying psilocybin treatment for IBS,  an indication that crosses the boundaries of gastroenterology and psychiatry, is a true innovation.” 

In recognition of this important development, Jim Gilligan, PhD, Chief Executive Officer of Tryp  Therapeutics, said, “We are excited to announce completion of Fluence’s training of psychotherapists for  our Phase 2a clinical trial in IBS-related pain. Completion of this training marks a significant step forward  in the development of our potentially groundbreaking treatment for patients suffering from this debilitating  condition. Collaborating with partners like Harvard/MGH and Fluence, a leader in providing psychotherapeutic training for health professionals administering psychedelic compounds to patients, 

represents an extraordinary opportunity to advance the field of psychedelic medicine and improve the  lives of countless patients.” 

About Tryp Therapeutics 

Tryp Therapeutics is a clinical-stage biotechnology company focused on developing proprietary, novel  formulations for the administration of psilocin in combination with psychotherapy to treat diseases with  unmet medical needs. Tryp’s lead program, TRP-8803, is 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. For more information, please visit www.tryptherapeutics.com. 

Investor & Media Contact 

Peter Molloy 

Chief Business Officer 

Tryp Therapeutics 

pmolloy@tryptherapeutics.com 

Forward-Looking Information 

Certain information in this news release constitutes forward-looking information. In some cases, but not  necessarily in all cases, forward-looking information can be identified by the use of forward-looking  terminology such as “plans,” “targets,” “expects” or “does not expect,” “is expected,” “an opportunity  exists,” “is positioned,” “estimates,” “intends,” “assumes,” “anticipates” or “does not anticipate” or  “believes,” or variations of such words and phrases or state that certain actions, events or results “may,”  “could,” “would,” “might,” “will” or “will be taken,” “occur” or “be achieved.” In addition, any statements that  refer to expectations, projections or other characterizations of future events or circumstances contain  forward-looking information. Statements containing forward-looking information are not historical facts but  instead represent management’s expectations, estimates and projections regarding future events. 

Forward-looking information is necessarily based on a number of opinions, assumptions and estimates  that, while considered reasonable by Tryp as of the date of this news release, are subject to known and  unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of  activity, performance or achievements to be materially different from those expressed or implied by such  forward-looking information, including but not limited to the factors described in greater detail in the “Risk  Factors” section of Tryp’s final prospectus available at www.sedar.com. These factors are not intended to  represent a complete list of the factors that could affect Tryp; however, these factors should be  considered carefully. There can be no assurance that such estimates and assumptions will prove to be  correct. The forward-looking statements contained in this news release are made as of the date of this  news release, and Tryp expressly disclaims any obligation to update or alter statements containing any  forward-looking information, or the factors or assumptions underlying them, whether as a result of new  information, future events or otherwise, except as required by law.

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