Clinical-stage biotech firm Tryp Therapeutics Inc. (CSE: TRYP) (OTCQB: TRYPF) was up nearly 50% in trading on Tuesday after it posted updates that touted promising results for its development of IV-channeled psilocin (the active metabolite of psilocybin) to treat rare neurological diseases.
The company reported its corporate highlights and audited financial statements for the fiscal year ending Aug. 31.
Tryp said that it has made “significant progress” expanding its IP portfolio, including filing provisional patents for the use of psilocybin to treat binge eating disorder and fibromyalgia. The company also saw its international PCT patent application for the intravenous administration (IV) of psilocybin and psilocin – dubbed TRP-8803 – published by The World Intellectual Property Organization.
“Tryp has continued to execute its multipronged strategy of exploring the clinical utility of psilocybin-assisted psychotherapy, expanding its IP portfolio, and advancing TRP-8803 (IV-infused psilocin), the company’s proprietary and eventual commercial product,” CEO Jim Gilligan said.
The company is not yet profitable due to it still being in the development stage, and operations have primarily been funded by the issuance of common shares after the company went public on the Canadian Securities Exchange in 2020.
Tryp posted a net loss of C$7.49 million and a negative cash flow from operating activities of C$5.8 million for the fiscal year. The company has accumulated a deficit of C$16.17 million since inception.
Rather than focusing on mental-health diseases like others in the medicinal-psychedelic space, the company has taken the approach of using psilocybin to treat other neurological-based, rare diseases that could receive approval more quickly, as drugs for these diseases often access accelerated regulatory pathways to expedite review processes.
Tryp said that administering psilocin through an IV “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.”
On the clinical development front, Tryp said that it had made strides in their Phase 2a clinical study with the University of Florida looking at using TRP-8802 (oral psilocybin) to evaluate psilocybin-assisted therapy among patients with binge eating disorders.
Early data results for the first patient dosed in the Phase 2a binge eating disorder trial supported the potential effectiveness of psilocybin and psilocybin-related compounds, with interim results for the first five patients slated to be available next month.
Tryp said that it is now preparing for a Phase 2a trial using TRP-8802 alongside the University of Michigan to evaluate psilocybin-assisted therapy among patients with fibromyalgia, a disease known widespread musculoskeletal pain accompanied by fatigue, sleep, memory and mood issues. The company expects the trial to begin in the first half of 2023 after the U.S. Food and Drug Administration (FDA) gave a nod of approval for its Investigational New Drug (IND) application in December 2021.
Gilligan added that the company “has completed a series of pharmacology and toxicology programs necessary to advance TRP-8803 into the clinic.”
“With a burgeoning pipeline and a variety of novel and impactful provisional patents in place, we look forward to continuing to execute our business plan in 2023 and beyond,” he said.