Clinical trials leading growth in psychedelics industry

Psychedelics investors are well aware of how important clinical trials are for the advancement of this industry.

Companies are focused on making sure these studies are up to par with standardized trials from medical regulators such as the US Food and Drug Administration (FDA) and Health Canada.

“From my perspective, 2021 was a big year for a lot of the companies coming in and declaring their intent to conduct research ... I think (2022) is going to be the year that we start to see those companies weed out those who pursue research and those who don't,” Andrew Charrette, director of regulatory affairs and psychedelic advisor with KGK Science, previously told INN.

Another expert observer of the psychedelics industry explained that the race to complete studies is evolving beyond the initial studies launched by companies.

“Basically every psychedelic pharmaceutical company that you can think of now is not only working on their classical psychedelics, but also on second and third generation ones,” James Halifax, host of the Psychedelic Investor, told INN In a previous interview.

1. Leading firm gets set for Phase 3 trial

One of the leading publicly traded psychedelics companies is nearing the start of a critical end stage of its study.

COMPASS Pathways (NASDAQ:CMPS) is researching the use of its COMP360 psilocybin candidate in combating treatment-resistant depression. As part of the Phase 2 portion of its work, the company underwent an open-label study using 25 milligrams of COMP360 alongside antidepressants on 19 patients.

“Patients were responsive to 25 milligrams of psilocybin, whether or not they were simultaneously receiving an SSRI antidepressant,” Dr. Guy Goodwin, chief medical officer with COMPASS Pathways, said.

In a recent financial disclosure to investors, the company confirmed it expects to meet with the FDA in late April to review its Phase 2 data. Following this meeting, the firm is planning to begin Phase 3 in the second half of 2022.

2. First public psychedelics company waiting on critical data

Mind Medicine (MindMed) (NASDAQ:MNMD,NEO:MMED), the first publicly traded psychedelics drug researcher, is not far behind, and intends to make progress on its own candidate in 2022.

It is set to kick off the Phase 2b trial for its Project Lucy program, which will evaluate the benefits of MM-120, a pharmacologically optimized form of LSD, in treating generalized anxiety disorder.

The company is encouraged thanks to the issuance of an investigational new drug clearance from the FDA for this study. MindMed plans to begin patient enrollment for Phase 2b early in 2022.

“The results of this trial will guide the dose selection and development strategy for our pivotal Phase 3 clinical trials,” Robert Barrow, CEO and director of MindMed, said.

3. Psychedelics up and comer has novel study

Small Pharma (TSXV:DMT,OTCQB:DMTTF) is pursuing its flagship study of DMT-based SPL026 in treating major depressive disorder. The company recently shared Phase 1 results and early data from a Phase IIa clinical trial.

The study looked at 32 healthy patients in a dose-escalating and placebo-controlled program. “This analysis provides additional insight into dose-related effects on the primary outcomes of safety and tolerability as well as on pharmacodynamic measures, including the treatment experience and subject well-being,” the company said.

The company saw no serious drug-related adverse events on patients and small mixed patient reactions.

“Positive discussions with the United States Food and Drug Administration paves the way for an international multi-site Phase IIb clinical trial, expected to commence in H2 2022,” the company said in a recent financial report.

4. Drug maker looking to get going with critical study

Psychedelics firm Cybin (NEO:CYBN,NYSEAMERICAN:CYBN) is keen to launch a trial for its flagship candidate CYB003, a psilocybin-based candidate.

In the planned trial, Cybin will evaluate its candidate against major depressive disorder and alcohol use disorder.

The firm expects to begin a Phase 1/2a trial midway through 2022 after submitting regulatory applications in the Q2 period, according to its most recent quarterly financials.

“Looking ahead, we believe that 2022 will be a pivotal year for Cybin, with multiple therapeutic programs currently on track to enter clinical development that are supported by our promising and differentiated preclinical data,” Doug Drysdale, CEO of Cybin, told investors.

Investor takeaway

The clinical trial process is one of the key elements in determining the success or failure of psychedelics companies. These studies have become the backbone behind the industry's future outlook, and the data from these research programs will help make or break the entire market, according to one advisor expert.

“When I say data, I don't mean like a bunch of observational data ... I mean real data that looks at efficacy with controlled clinical trials — the gold standard of clinical trials, (which) are accepted by the regulatory bodies,” Sabrina Ramkellawan, co-founder and chief operating officer of the Knowde Group, said at the Lift Expo in 2021.