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


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

COMPASS Pathways looks good with its magic mushroom trials and is one step closer to FDA approval. Its 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 that’s happening in this new and emerging medical field, and you can follow by signing up to The weekly Cannadelics newsletter. Get all the latest industry news and be the first to get access to new deals and offers on psychedelics as they begin to hit the market.


What is COMPASS Pathways?

COMPASS course is a UK-based mental health agency working to accelerate access to innovative treatments for patients. Created by George Goldsmith and Ekaterina Malievskaia, the company was born out of the pain and depression of their personal lives and the realization that current models of mental health treatment are not adequate to provide concrete answers to these problems.

With this idea, the two teamed up with Lars Christian Wilde to form COMPASS Pathways to find and promote better ways to treat mental health. According to the company, “Each of us is committed to discovering and developing new therapies that will help patients and their families, and ease the burden on our overburdened healthcare systems. For too many people, healthcare Today’s mental state is not enough. We are determined to change that.

The company’s first major initiative is the COMP360 psilocybin therapy, which is in trials. How effective have these trials been? Not only have recent trials been positive, prompting COMPASS to go public, but positive results have been shown so early that COMPASS has received ‘revolutionary therapy‘ 2018 FDA designation for the treatment. And this even though psilocybin is a Schedule I drug – and therefore completely illegal. This psilocybin treatment aims to help people suffering from major depression.

psilocybin trials

COMPASS Magic Mushroom Trials

What are these trials that propelled COMPASS to an IPO in 2020? COMPASS Pathways has been working on psilocybin trials for several years, with results from its IIb trials showing a reduction in symptoms of depression. The trials were randomised, controlled and double-blind, meaning that researchers and trial participants were all blinded to who was receiving which treatment; and the people chosen for different groups were chosen at random.

COMP360 is the specific psilocybin drug used in the trials. This was given to 233 patients who also received psychological therapy at the same time. All participants stopped other antidepressant drugs before the trials began and received only one dose, either 25 mg or 10 mg, which was also compared to a 1 mg dose.

According to COMPASS, there was a “statistically significant and clinically relevant reduction in the severity of depressive symptoms after three weeks”. These phase II trials are specifically aimed at finding the correct dosage. The designated dose will then be used in phase III trials, which are the last before a drug can be approved. According to trial information, 179 participants reported an adverse effect, but usually nothing more than headache, nausea, fatigue, or insomnia. 12 reported more serious effects such as suicidal behavior, intentional self-harm and suicidal ideation. Overall, more than 90% of treatment-related adverse events were considered mild.

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

After details COMPASS magic mushroom trials

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

Regarding the 10 mg group compared to the 1 mg group, there was no statistically significant difference after three weeks. MADRS responses were assessed by an independent assessment group that was separate from the trials and unaware of the study design or patient details.

magic mushroom therapy

At least 2 times the participants in the 25 mg group showed a positive response and a decrease in depressive symptoms at 3rd week and 12and week, compared to the 1mg group. At 12and week, 20.3% of the 25 mg group versus 10.1% of the 1 mg group showed the protocol-defined sustained response. When using a consistent definition of “sustained response”, consistent with other TRD (treatment resistant depression) studies, the difference becomes 24.1% in the 25mg group versus 10.1% in the 1mg group.

Of the 233 study participants, 94% had never been exposed to psilocybin. Participants came from 10 different countries in North America and Europe. All of the cases were considered treatment-resistant depression, which means that they had already undergone at least two antidepressant treatments, which did not help.

Much like MAPS, which is working on an MDMA drug, and which structured its phase III trials with direct help from the FDA, so is the COMPASS pathways as it considers phase III of its own drug trials. magic mushrooms. According to the company’s chief medical officer, “We now look forward to meeting with the FDA early in the new year in light of this new data to finalize our plans for the Phase III program, which is expected to begin in the third quarter of 2022.”

COMPASS Pathways is publicly listed

COMPASS is not a seedy little company rooted in mud. It is actually a leading company and a listed on the stock exchange one, despite working with a Schedule I substance. COMPASS completed its IPO at the end of October 2020, even ringing the opening bell for the Nasdaq Stock Exchange to celebrate October 26and2020. For the IPO, the company raised $146.6 million.

As the bell rang, Goldsmith said, “I am honored to ring 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 team of 60 shares our strong sense of purpose and our determination to reduce the personal and economic burden of mental health suffering.

Not only is COMPASS listed on the stock exchange, but it also got the FDA stamp of approval… to some extent. No, nothing has been officially approved, of course, as COMP360 is still being tested. But it’s gotten as close as it gets for now. On October 23, 2018, it was announcement U.S. FDA has awarded COMP360 a Breakthrough Therapy designation. However, COMPASS is NOT the only company receiving this for magic mushroom research. In 2019, Usona Institute also obtained Breakthrough Therapy Designation from the FDA for its magic mushroom drug.

revolutionary therapy

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

COMPASS lanes are one of the several growing companies who support the medical use of psychedelics. It’s a major point of interest for those wanting to invest in the emerging psychedelic market, and it’s likely to be the first company to officially approve a psilocybin drug.

Conclusion

As COMPASS Pathways enters Phase III of its trials, it is one step closer to a final point where its drug COMP360 can be submitted for FDA approval. If he gets there before MAPS gets his MDMA drugs there (and before Usona gets its own magic mushroom drug), it will be the second company to get a psychedelic drug approved for mental health purposes. Johnson & Johnson was first with its sister drug ketamine esketamineunder the name Spravato, which was approved in 2019.

If that were to happen – and it looks like we’re headed in that direction – it would mean much higher profile legalization than what Spravato got, and a recalculation of how the United States regulates psychedelic drugs. It could even push for full federal legalization of medical psychedelics. Stay tuned to life to find out what is going on.

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