The share price of Tryp Therapeutics Inc. (CSE: TRYP) (OTCQB: TRYPF) rose 20% in trading Thursday afternoon after the clinical-stage biotech firm published preliminary results that showed promising improvements in patient binge-eating episodes for its Phase 2a oral psilocybin-assisted therapy.
The results were part of a pilot analysis meant to pave the way for further development and trial testing of IV-channeled psilocin (the active metabolite of psilocybin).
The vision, Tryp CEO Jim Gilligan told Green Market Report, is to administer psilocin using an IV so that it is more analogous to the work of anesthesiologists, where patients are medically put to sleep and reawakened after.
It also would allow for serotonin antagonists to “turn off” the trip.
“There’s a couple of drugs you could actually put in to just block it,” Gilligan said. “So I mean, you could do a rescue drug.”
The CEO said that the proprietary IV formulation of psilocin alleviates “numerous shortcomings” of oral psilocybin, such as:
- Shortening the time it takes for a patient to reach a psychedelic state.
- Controlling the depth and duration of the psychedelic experience.
- Reducing the overall duration of the intervention to a commercially feasible timeframe.
Peter Molloy, the company’s chief business officer, said that the FDA instructed Tryp to use oral psilocybin for the initial studies before moving onto the company’s proprietary IV formulation of psilocin, TRP-8803.
“Subsequent studies where we see a positive signal with binge eating will be with 8803 (the proprietary IV formulation),” he said. “That’s a strategy that reduces the cost, reduces the risk. And that creates a much more advantageous commercial pathway forward.”
Gilligan added, “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.
“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,” he said.
Jesse Dallery, the study’s lead psychologist at the University of Florida, said in a statement that the results from single-dose psilocybin paired with therapy are “clinically meaningful and highly promising.”
The company previously announced that the first trial patient exhibited reduced overall anxiety, reduced anxiety around food, reduced compulsion to overeat, as well as improved self-image and confidence. This week’s results for the additional four patients has reinforced those initial clinical observations.
“The current results demonstrated a significant reduction in the frequency of binge eating behavior for each patient as measured in multiple assessments of efficacy which were discussed with the FDA as acceptable endpoints in advance of this study,” the release said.
Findings showed that daily binge eating episodes across all five patients in the study fell by an average of 80.4% from baseline during the four-week post-dosing measurement period. All patients reporting a daily reduction in binge eating episodes of at least 60%, the company said.