2022 is expected to be a pivotal year for the psychedelic medicine industry, as the sector attempts to solidify itself as a bonafide biotech disruptor. Will it get stuck in these early developmental stages? Or will the industry take the next step towards legitimacy?
The success or failure of the sector’s advanced clinical trials will give us the answer. Here’s a second look at the top trials coming up in 2022.
Small Pharma’s Phase 2a Trial: Major Depressive Disorder with DMT
Phase 1 of Small Pharma’s DMT-assisted therapy was completed in the fall of 2021 and was demonstrated to be well-tolerated and safe. The Phase 2a clinical trial will explore the effectiveness of SPL026 in combination with psychotherapy for the treatment of Major Depressive Disorder.
SPL026 is Small Pharma’s intravenous (“IV”) version of N,N-dimethyltryptamine or DMT. The company has now initiated the blinded, randomized, placebo-controlled, Phase 2a study of SPL026 in combination with psychotherapy in 42 patients with MDD. The study is being held at two UK clinical trial sites and will assess the efficacy of one versus two doses of SPL026 in combination with psychotherapy in patients with MDD. Patients have already begun treatment and topline results are expected in the first half of 2022.
Due to its powerful potential and short trip time, DMT is gaining popularity amongst investors and researchers. If positive results can be had in 2022, Small Pharma will find itself at the forefront of DMT development.
Awakn Life Sciences’ Phase 3 Trial: Ketamine Therapy for Alcohol Use Disorder
In January of this year, Awakn Life Science sent a surprising buzz across the industry with positive results in their Phase II A/B trial. It was the world’s first controlled trial investigating ketamine-assisted therapy for the treatment of Alcohol Use Disorder — and the results were extremely encouraging.
86% of patients remained abstinent from alcohol six months after treatment, and relapse rates were almost 3 times lower than with the placebo. These are results the psychedelic medicine industry has been dreaming of.
There’s no date set for the Phase 3 trial, but the company says the Phase 2 results are enough to progress the trial to the third phase. Considering Awakn’s close relationship with the UK National Healthcare Service (NHS) and with ketamine already being an approved substance, the path is set for a potentially accelerated track forward. If Awakn can begin even the earliest logistical steps of Phase 3 in 2022, the firm will be on its to cementing itself as one of the leaders in the clinical trial process.
GH Research: 5-MeO-DMT for Depression
There’s another DMT player quietly doing some impressive work over in Europe. Since day one, GH Research has been the most low-key player in the space, raising impressive amounts of capital and listing on the NASDAQ — all with little fanfare and very little media coverage.
Yet like the tortoise, they are quietly going about winning the race. Back in December, GH Research announced positive results of the Phase 2 part of their Phase 1/2 clinical trial, using their GH001 compound in treatment-resistant depression (TRD). GH001 is their 5-MeO-DMT lead candidate drug, and early Phase 2 results had an impressive 87.5% remission rate in depressive symptoms after 7 days (although it was a very small sample size).
The company says it’s working on a pre-IND meeting with the FDA and a Scientific Advice meeting with the EMA, hoping to start a larger Phase 2b trial. If they can get Phase 2b approved and started in 2022, GH Research will start to move from secret darkhorse to mainstream top-tier player (note: the firm’s cash position is extremely healthy, with somewhere around $250 million cash on hand).