- Tryp Therapeutics on September 22 submitted an IND application to the FDA to evaluate its oral formulation of synthetic psilocybin, TRP-8802, in a Phase 2a clinical study
- The study seeks to evaluate TRP-8802 for the treatment of patients with eating disorders and will enroll 10 patients
- According to Tryp Chairman and CEO, the submission is the first of several IND filings the company intends to make in the coming months
- Tryp is also preparing for Phase 2b clinical trials, which will evaluate its proprietary drug candidate, TRP-8803
During a recent investor presentation, Tryp Therapeutics (CSE: TRYP) (OTCQB: TRYPF), a pharmaceutical company focused on developing novel bioscience solutions for conditions with high unmet need, expressed its expectation to initiate at least two Phase 2a clinical trials in Q4 2021 (https://ibn.fm/H85KV). The trials, to be conducted at the University of Florida under the guidance of Dr. Jennifer Miller, a pediatric eating disorders expert and the trials’ principal investigator, will evaluate TRP-8802, Tryp’s oral formulation of synthetic psilocybin, in combination with psychotherapy.
The company announced September 22 that it had submitted to the US Food and Drug Administration (“FDA”) an Investigational New Drug (“IND”) application to evaluate TRP-8802 in the Phase 2a study for the treatment of patients with eating disorders (https://ibn.fm/ze4vd), acting as its first major clinical development milestone.
According to Dr. Miller, the submission represents hundreds of hours of preparation, design, and coordination as Tryp and its partners “pursue a leading-edge treatment of psilocybin with psychotherapy.” Part of the efforts Dr. Miller was alluding to include collaborations with Clinlogix, a contract research organization (“CRO”), the University of Florida, and Fluence, a psychedelic therapy educational platform.
In late August, Fluence undertook and completed the training of psychotherapists who will take part in the trial by overseeing dosing sessions (https://ibn.fm/7G3Ri). On its part, Clinlogix will support the upcoming Phase 2a clinical trials by providing medical writing, biostatistical analysis, data management, and trial monitoring (https://ibn.fm/BP4YW).
The submission sets the stage for the Phase 2a clinical trial subject to a favorable review by the FDA. The study is expected to enroll 10 patients with various overeating disorders, such as hypothalamic obesity, binge eating disorder, and Prader-Willi Syndrome. The administration of TRP-8802 is expected to enhance neuroplasticity and help create healthy neural patterns associated with hunger and eating. Prior to the administration, the patients will meet with the trained psychotherapists for two sessions. The psilocybin will then be administered during two drug-dosing sessions, after which integration sessions will follow.
“This IND submission marks the most important milestone the company has achieved to date and will be critical in identifying patient responses to the active ingredient, consistent with that of our proprietary drug candidate, TRP-8803, that will be used in Phase 2b trials and beyond,” said Tryp Chairman and CEO Greg McKee.
McKee also noted that the submission is the first of several IND filings the company expects to make in the coming months, further reiterating that Tryp is eager to begin enrolling its first patients in multiple Phase 2a trials later this year.
For Tryp, this is only the beginning. The company intends to use TRP-8803, its proprietary psilocybin-based drug product manufactured exclusively for Tryp, for Phase 2b clinical trials, and beyond. It has already announced partnerships with the University of Michigan, Calvert Labs, and Gad Consulting to conduct bridging studies in preparation for Phase 2b clinical trials, with more collaborations possibly still in the works. In this regard, the clock has begun counting what will likely be hundreds of additional hours of preparation, design, and coordination in readiness for the Phase 2b trials.
For more information, visit the company’s website at www.TrypTherapeutics.com.
NOTE TO INVESTORS: The latest news and updates relating to TRYPF are available in the company’s newsroom at https://ibn.fm/TRYPF
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