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The Commercialization of Next Generation Psychedelics for Therapy

Robin Lefferts

January 31st, 2022

Psychedelics, Top News

Naturally occurring psychedelics, such as psilocybin from mushrooms and DMT from a wide variety of sources, have been shown to act on the nervous system in potentially beneficial ways. Research is happening all over the world. Johns Hopkins has a research center focused on psychedelics, and scientists there have found evidence of psilocybin’s benefit for quitting smokers, anxious cancer patients, alcoholics trying to stay sober, and depressed people. Despite all of the scientific evidence, significant barriers remain to the approval and commercialization of psychedelic therapies.

Mindset Pharma Inc. (CSE: MSET) (OTCQB: MSSTF) has seen the evidence of efficacy and the difficulties of commercialization and may just have a recipe for the solution. Mindset has a platform for developing next generation psychedelic medicines, inspired by and improving upon the original drugs like psilocybin and DMT. With eight patent applications under its belt and four ‘families’ of drug candidates identified, the company is moving into its commercialization phase.

What is the importance of intellectual property in Mindset Pharma’s business?

Mindset is a drug discovery company and is looking to partner with or sell to pharma companies that have the capacity to take drug candidates through the expensive and time-consuming clinical trial process. Intellectual property (IP) protection is difficult or non-existent with the naturally-occurring compounds, while Mindset’s approach allows for the type of protection that could entice customers to take the plunge. Couple the IP with Mindset’s extensive data showing the potential for its creations to improve on the original substances, in terms of safety and duration, without sacrificing efficacy, and you have a compelling business model which is beginning to bear fruit.

Mindset’s Deals, So Far

Mindset Pharma has spent the past few years screening, testing, and developing its families of next generation psychedelic drug candidates, and these processes won’t stop. But the company is looking at 2022 as the year it starts to focus on partnering to advance these compounds to the clinic. The news in the first month is certainly promising.

What can you tell us about the new drugs Mindset Pharma has created to this point?

Right off the bat, Mindset announced a collaboration with The McQuade Center for Strategic Research and Development. The McQuade Center is part of the Tokyo-based multinational company Otsuka Pharmaceutical, and is dedicated to advancing and nurturing early-stage opportunities that can change the landscape of treatments for mental illness and renal disorders. The McQuade Center has made a strategic investment in support of Mindset’s research, with an upfront payment of $5 million, and is committed to financing two families of Mindset compounds through the completion of Phase 1 clinical trials. In return, The McQuade Center gets a right of first refusal on drugs developed under the collaboration.

Mindset Pharma gets money in the bank now, and a financing commitment to bring some of its drug candidates to the point where they could reasonably be sold or licensed. The company anticipates the cost of bringing multiple candidates through Phase 1B could run up to $45 million or so. The McQuade Center/Otsuka is gambling, based on the promising data behind Mindset’s innovations, that it can come out of the deal with at least a drug or two suitable for more advanced trials and potential approval. Mindset benefits tremendously from the non-dilutive financing commitment and will be able to negotiate more transactions, with Otsuka or perhaps another company, should any number of the candidates make it to Phase 2 trials.

This deal centers on two of Mindset’s current four families of molecules. One is a group of psilocybin-inspired creations that tend to have a shorter duration of effect than psilocybin does. Such a drug would lend itself to in-clinic treatments that need to be supervised, with the shorter duration allowing for a more tolerable patient experience as well as the ability to treat more patients per clinic. The other family of compounds is based on 5-MeO-DMT, a drug that produces very intense but shorter psychedelic experiences with a propensity toward undesirable side effects. Mindset’s version has been shown, preclinically, to greatly reduce those side effects

The Otsuka collaboration does not involve Mindset’s two other families, including that of its most advanced candidate. MSP-1014 has the potential to be stronger, safer, and more cost-effective than psilocybin. Preclinically, MSP-1014 has demonstrated a significantly improved safety profile in preclinical studies, including completely attenuating the reduction in core body temperature that was observed with psilocybin. It also shows a stronger effect on the 5-HT2A receptors than psilocybin. It’s designed to potentially replace psilocybin and could require lower dosage levels to achieve the same effects.

Due to interest from other companies and in anticipation of a potential deal, Mindset announced an agreement with a leading contract development and manufacturing company (CDMO) to produce MSP-1014. Notably, MSP-1014 is not a scheduled substance like psilocybin is, making it a potentially attractive pharmaceutical alternative to the natural drug. Mindset also anticipates its manufacture will be simpler and less costly than producing psilocybin at scale.

“Following our co-development announcement with the McQuade Center for Strategic Research and Development, a member of the Otsuka Pharmaceuticals family of companies, for our short-duration compounds (Mindset Families 2 & 4), we continue to receive interest from potential partners for our wider portfolio of differentiated next-generation drug candidates. As such, our manufacturing agreement with a leading CDMO positions MSP-1014 well for partnership opportunities to advance this optimized compound to human clinical trials,” said James Lanthier, Chief Executive Officer of Mindset. “In preclinical trials, MSP-1014 has shown improved efficacy and safety compared to first-generation psilocybin. Also, it has demonstrated pharmacological diversity making it potentially suitable for both in clinic treatment approaches and as a take-home medicine.”

More to Come

The manufacturing arrangement sets the table for deals surrounding Mindset’s most advanced compound, MSP-1014, and commercialization of that drug candidate is high on the list of priorities for the company in the coming months. Investors should look with interest at what that deal, or those deals, look like.

The Otsuka partnership accelerates the development of two of Mindset’s existing drug families, with the potential to move candidates through Phase 1 trials in the next 12-18 months. Nobody knows how many drugs will reach that stage, but there is potential for several candidates to come out of these two families.

Mindset also has many other compounds in various stages of development, with the possibility of advancement and commercialization a bit more into the future. And the company is poised to expand research and drug-identification efforts into other areas beside psilocybin, DMT, and 5-MeO-DMT.

Why is Mindset Pharma focused on new psychedelic drugs?

The psychedelic pharmaceutical industry as a whole is an unruly and emergent entity, with scientists trying to catch up after years of what amounts to prohibition on research. Mindset Pharma’s model is just the sort of approach that can bring legitimacy, advancement, and even profits to the fledgling market that desperately needs just those sorts of things. Stay tuned.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Robin Lefferts

Robin Lefferts has been involved in the legal cannabis industry since 2012, sometimes as an active participant and always as an interested observer.

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