COMPASS Pathways Magic Mushroom Drug Shows Very Positive Results in IIb Trials

As the psychedelics industry grows, more companies that once would never have had the option, are now going public. Such is the case with COMPASS pathways, which is getting closer to a legalization with the positive results of its magic mushroom trials. Not only are trials going well, but the company has been publicly traded since 2020.

COMPASS Pathways is looking good with its magic mushrooms trials, and is getting that much closer to an FDA approval. It’s new drug COMP360 is a psilocybin treatment that the FDA is already helping promote with its ‘breakthrough therapy’ designation. We’re here to cover everything going on in this new and emerging medical field, and you can keep up by signing up for The Cannadelics Weekly Newsletter. Get all the latest news in the industry, and be the first to gain access to new deals and offers on psychedelic products, as they start to enter the market.


What is COMPASS Pathways?

COMPASS pathways is a UK-based mental health agency that works to accelerate access to innovative treatments for patients. Established by George Goldsmith and Ekaterina Malievskaia, the company came out of the pain and depression of their personal lives, and the realization that current mental health treatment models are not adequate in providing real world answers to these problems.

With that idea, the two partnered with Lars Christian Wilde to form COMPASS Pathways in order to find and promote better mental health treatment methods. As per the company, “Every one of us is committed to discovering and developing new therapies that will help patients and their families, and ease the burden on our overstretched healthcare systems. For too many people, mental health care today isn’t good enough. We are determined to change that.”

The first major initiative of the company is the COMP360 psilocybin therapy, which is undergoing trials. How effective have these trials been? Not only have recent trials turned out positively, spurring COMPASS into going public, but positive results were shown so early, that COMPASS received ‘breakthrough therapy’ designation from the FDA in 2018 for the treatment. And this even though psilocybin is a Schedule I – and therefore completely illegal – drug. This psilocybin treatment is aimed at helping those with major depression.

psilocybin trials

COMPASS magic mushroom trials

What are these trials which propelled COMPASS pathways to an IPO in 2020? COMPASS Pathways has been working on psilocybin trials for several years, with results of its IIb trials showing reduced symptoms of depression. The trials were randomized, controlled, and double-blind, meaning the researchers and trial participants were all unaware of who was getting what treatment; and the people chosen for different groups were chosen randomly.

COMP360 is the specific psilocybin drug used in the trials. This was given to 233 patients who were also given psychological therapy at the same time. All participants stopped other antidepressant medication prior to trials beginning, and were given only one dose, of either 25mg or 10mg, which was compared to a 1mg dose as well.

According to COMPASS, there was a “statistically significant and clinically relevant reduction in depressive symptom severity after three weeks.” These phase II trials are specifically about finding correct dosing. The designated dose will go on to be used in phase III trials, which are last before a drug can be approved. According to trial information, 179 participants did report an adverse effect, but generally nothing more than headaches, nausea, fatigue or insomnia. 12 reported more serious effects like suicidal behavior, intentional self-injury, and suicidal ideation. Overall, over 90% of treatment-emergent adverse events were considered only mild.

Says George Goldsmith, COMPASS’s CEO, “We set out to explore the safety and efficacy of COMP360 psilocybin therapy in treatment-resistant depression, through a rigorous and large-scale trial, and to find an appropriate dose to take to the next stage… With these compelling data, we will urgently progress our clinical development program and move closer to making this therapy accessible to patients in need, if approved.”

More specifics of the COMPASS magic mushroom trials

Here’s some more of what was specifically found in the trials. When comparing the 25mg group and the 1mg group, the 25mg group had a -6.6 difference on the MADRS (Montgomery-Asberg Depression Rating Scale) at week 3 (p<0.001). This higher mg group showed statistical significance on the MADRS the very next day after the COMP360 treatment was administered (p=0.002).

In terms of the 10mg group compared to the 1mg group, there was no statistically significant difference after three weeks. The MADRS answers were assessed by an independent rating group which was separate from the trials, and unaware of the study design or details of patients.

magic mushroom therapy

At least 2X the participants in the 25mg group showed a positive response and lessening of depressive symptoms at the 3rd week and 12th week, in comparison to the 1mg group. At the 12th week, 20.3% of the 25mg group vs 10.1% of the 1mg group, showed the protocol-defined sustained response. When using a consistent definition of ‘sustained response’, in line with other TRD (treatment resistant depression) studies, the difference becomes 24.1% of the 25mg group vs 10.1% of the 1mg group.

Of the 233 participants in the study, 94% had no previous exposure to psilocybin. Participants came from 10 different countries from North America and Europe. All cases were considered treatment-resistant depression, which means they had already undergone two or more anti-depressive treatments, which did not help.

Much like MAPS, which is working on an MDMA medication, and which structured its phase III trials with help directly from the FDA, this is the case with COMPASS pathways as it looks to phase III of its own magic mushroom trials. According to the company’s Chief Medical Officer, “We are now looking forward to meeting with the FDA early in the new year in light of these new data to finalize our plans for the phase III program, which we expect to begin in Q3 2022.”

COMPASS Pathways is publicly traded

COMPASS is not some little dingy company rooting around in the dirt. It is, in fact, a high profile company, and a publicly traded one, despite the fact it works with a Schedule I substance. COMPASS completed its IPO in late October 2020, even ringing the Nasdaq Stock Exchange opening bell to celebrate on October 26th, 2020. For the IPO the company raised $146.6 million.

At the time of the bell ringing, Goldsmith said, “I am honored to be ringing the Nasdaq opening bell on behalf of everyone at COMPASS Pathways. We are on a mission to transform mental health care and I know that every member of our 60-person team shares our strong sense of purpose and our determination to reduce the personal and economic burden of mental health suffering.”

Not only is COMPASS publicly traded, but it’s also got an FDA stamp of approval…to a degree. No, nothing has been officially approved, of course, as COMP360 is still undergoing trials. But it got as close as it can for now. On October 23rd 2018, it was announced that the US’s FDA gave COMP360 a ‘breakthrough therapy’ designation. COMPASS is NOT the only company to receive this for magic mushroom research, though. In 2019, Usona Institute also got a breakthrough therapy designation from the FDA for its magic mushroom drug.

breakthrough therapy

This designation is given when “preliminary clinical evidence shows that it may demonstrate substantial improvement over available therapy. Breakthrough Therapies are supported by the FDA throughout the clinical development program to ensure as efficient a process as possible.” In other words, it’s meant to get a product to market faster.

COMPASS pathways is one of several growing companies that support the medical use of psychedelics. It is a major point of interest for those who want to invest in the emerging psychedelics market, and will likely be the first company to have a psilocybin medication officially approved.

Conclusion

As COMPASS Pathways gets into Phase III of its trials, it gets that much closer to an endpoint where its drug COMP360 can go up to the FDA for approval. If it gets there before MAPS gets its MDMA drug there, (and before Usona gets its own magic mushroom drug there) it will be the second company to have a psychedelic drug approved for mental health purposes. Johnson & Johnson was first with its ketamine-sister-drug esketamine, under the name of Spravato, which was approved in 2019.

Should this happen – and it looks like we’re going in that direction, this would mean a much more high-profile legalization than what Spravato got, and a new reckoning for how the US federally regulates psychedelic drugs. It could even push forth an entire federal medical psychedelics legalization. Stay tuned to life to find out what happens.

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