Rarely has there been an investment community so focused on the science. Normally concerned with market closings and earnings calls, suddenly we have investors around the world waiting for Phase 2 clinical trial results with bated breath.
While many other biotech stocks are also heavily dependent on drug development, they’ll often have products already in the market, thus splitting investor’s attention between the lab and the performance of current product offerings
Yet with psychedelic medicine, we have the weight and expectations of an entire industry almost completely focused, and dependent on, the drug development process.
2022 is expected to be a pivotal year, with the industry attempting to solidify itself as a commercially viable endeavor. Will it remain a solely aspirational psychedelic dream? Or will the industry take the next step towards biotech legitimacy?
There’s a big difference between positive preclinical or Phase 1 results — and the rigors of larger Phase 2b or Phase 3 trials. This is where we separate the real deals from the pretenders. If the following clinical trials can replicate early successes, then we’ll likely see a rush of new longer-term biotech investors willing to put their money into the space.
Let’s have a look at some of 2022’s most important upcoming clinical trials:
MAPS’ Phase 3 trial: MDMA for PTSD
We’ll start here because this is the industry’s most advanced clinical trial. This will be the second Phase 3 trial under this program, with the first showing extremely positive results. 67% of patients treated with MDMA-assisted therapy no longer met the official criteria for having PTSD; while 88% of patients saw their symptoms decrease by 50% or more. Amazing stuff for a Phase 3 trial.
Those first Phase 3 results by MAPS sent positive waves throughout the industry and helped reinforce the thesis among investors and medical professionals. According to MAPS, the second, confirmatory Phase 3 trial of MDMA-assisted therapy for PTSD is now fully enrolled at 13 sites in the United States and Israel.
“If the MAPP2 study results, available after October 2022, are statistically significant for a reduction in PTSD symptoms and meet the FDA standards for safety, MAPS and MAPS PBC are planning to submit a New Drug Application to the FDA in the first half of 2023.”
Compass Pathways Phase 3: Psilocybin for Treatment-Resistant Depression
Compass received FDA Breakthrough Therapy designation in 2018 for their COMP360 psilocybin compound. In late 2021, the firm completed the world’s largest study to date, a double-blind phase 2b study of COMP360 psilocybin therapy in 233 patients with Treatment-Resistant Depression (TRD) in 22 sites across Europe and North America.
The Phase 2b results were solid, but nowhere as revolutionary as MAPS’ trial. You can see details here. There may have been issues with the trial setup and the fact that they are attempting to treat the most severe cases of depression, with patients who’ve tried everything else and failed.
The Phase 2b results in Nov 2021 did have a somewhat negative effect on the market, but that was probably due to unrealistic expectations after a year of psychedelics riding so high. Psilocybin for depression is one of the industry’s biggest hopes, so a lot is running on these trial results.
Compass is now enrolling for Phase 3 with plans to start the trial later in 2022.
MindMed Phase 2b Trial: LSD for Anxiety
In May, MindMed collaborators at the Liechti Lab and the University Hospital Basel announced topline data from their Phase 2 trial using LSD for anxiety. The results demonstrated significant and beneficial effects of LSD to safely mitigate symptoms of anxiety and depression.
These positive results will support MindMed’s LSD program as it makes its way through FDA approval, and also gives hope that the upcoming Phase 2b trial will be successful for both the company and patients. The planned Phase 2b has received approval from the FDA and MindMed says the trial is underway, although we’re still a bit light on details.
Generalized Anxiety Disorder is a serious condition affecting millions of people worldwide, and we’re in need of new treatment alternatives. Also MindMed is the only firm currently studying LSD at this advanced level, so success here will do a lot in returning this famous compound to credibility in the scientific community. And the psychology here cannot be understated — MindMed has always been the industry’s fan favorite, a sweetheart in the minds of enthusiasts and a media darling who gets the headlines. Positive Phase 2b results from the unofficial industry leader could be the boost in the arm the space has been waiting for.
Stay tuned for updates on these trials and for a continued list of important trials in the space…
