Mindset Pharma is a neuro-pharmaceutical drug development platform looking to advance medicines based on psychedelic substances. The company listed on the Canadian Securities Exchange on December 23rd, 2020 under the ticker “MSET”. Mindset was listed through a reverse takeover of North Sur Resources, a defunct mining company. Like many other companies looking to garner institutional interest from Europe, Mindset also listed its shares on the Frankfurt Stock Exchange under the ticker “9DF”. As of March 9th 2021, Mindset had a market capitalization of $54mn.
Instead of building its own research capabilities, Mindset follows a “virtual model” where it leverages third-party contract research organizations to perform laboratory synthesis and pre-clinical testing. This approach is efficient and cost-effective, and it ensures that the company retains all rights to its intellectual property.
To further its mission of developing medicines for various mental illnesses, Mindset is assembling a holistic intellectual property portfolio related to the synthesis and production of psychedelic medicines for use as prescription medications.
Patents & IP Overview
During the pre-clinical drug discovery stage, the final goal is to identify and select novel chemical entities (NCEs) which have efficacy characteristics that would make them promising candidates to bring to clinical trials.
In February 2020, Mindset filed two provisional patents with the USPTO covering two novel diverse chemical compounds protecting the discovery and development of these NCEs. The company is now looking to advance its proprietary compounds through a highly focused and carefully designed in vivo program to further elucidate their pharmacokinetic properties, safety profile, and efficacy, with a goal of selecting one or more lead drug candidates to advance to Proof of Concept human clinical trials.
The data from in vivo studies demonstrated that the compounds that showed 5HT2A activity are also showing in vivo behavioural evidence of 5HT2A activity that can be blocked with pre-treatment of a full antagonist. Moreover, the compounds are showing oral activity and promising duration of action in rodent pharmacokinetics studies.
On the basis of these preliminary results, Mindset filed a provisional USPTO patent for a third class of compounds in December 2020. With this, Mindset has now filed three final PCT patents for prodrugs, deuterated compounds, and sidechain restricted analogs. More details of these drug candidates are provided in the section below.
Mindset’s Drug Program
Mindset has developed a leading pipeline of diverse patent-pending pre-clinical psilocybin-inspired drug candidates. Its new drugs are broadly grouped into three “families”.
The first family can further be divided into prodrugs and deuterated analogs of psilocybin. The former has shown rapid metabolism into psilocin with verified efficacy both in vitro and in vivo. The deuterated analogs have shown similar effects as psilocin on receptor binding and function assays and in vivo data indicate similar efficacy to psilocybin with oral bioavailability and central nervous system penetration. This positions this first family of compounds as potential rapid drug development candidates for generic patentable psilocybin.
The second family, which consists of restricted side-chain analogs of psilocybin, show increased potency and efficacy compared to psilocin and psilocybin based on both in vitro and in vivo data, respectively. Certain compounds also show oral bioavailability and are brain penetrant with in vivo pharmacokinetic evidence of shorter duration than psilocybin. This profile positions this second family of compounds for next generation in clinic candidates to support psychedelic-assisted psychotherapy applications and protocols.
The third family continues to demonstrate unique and promising in vitro profiles. In particular, certain compounds from the third family show a similar binding profile to the human 5HT2A receptor comparable to that of psilocin, but with smaller effect size and a much longer duration of action based on human liver microsome stability data. This profile uniquely positions the third family of compounds for potential microdosing applications, including specialized populations and indications such as pediatric ADHD and Alzheimer’s disease.
The results of these PoC studies indicate that Mindset has several promising psilocybin-inspired drug candidates with differentiated pharmacological properties.
Mindset’s Synthesis Process
The company also has a patent-pending synthesis process which complements its drug development program. The management is fairly certain that this process represents a significant potential commercialization opportunity.
The process is innovative in that it offers a cost-effective synthesis process for large scale cGMP synthesis of psilocybin. Given the increasing number of trials and studies underway utilizing psilocybin, management expects significant demand for its proprietary, high-quality psilocybin supply.
At the moment, high-quality psilocybin for clinical research purposes is expensive and difficult to procure. Many contract development and manufacturing organizations (CDMOs) that specialize in psilocybin synthesis have exclusive relationships with individual clients, which drastically reduces the supply of psilocybin. Mindset believes that its process can benefit the entire medical psychedelic market, from the drug design process stage to clinical treatment given that it is a scalable, efficient, and cost-effective solution with a non-optimized cost per gram substantially below current retail costs.
The Mindset synthesis process potentially represents a superior route to synthesizing psilocybin than the established methodologies used today. In fact, in the last week of February, Mindset announced that it has engaged a leading CDMO to synthesize a 1.0 kg batch of cGMP (i.e., pharmaceutical grade) psilocybin utilizing this synthesis process. The large scale cGMP synthesis batch is expected to be released in the fall of 2021.
To summarize, Mindset Pharma has a portfolio of several compounds which show a great breadth of the desired pharmacological characteristics which not only show great potential for psychedelic-assisted psychotherapy, but also as potential medications which can be taken home and self-administered by patients. The growing body of evidence and research in support of the therapeutic benefit of psychedelics and the increased willingness of regulators to consider psychedelic drugs as a valid treatment option for neuropsychiatric disorders will greatly benefit companies like Mindset Pharma. We highlight the investment rationale below for investors looking for quality exposure in the psychedelics space.
- Advancing an IP portfolio of innovative new psychedelic medicines that leverage clinical research into classic psychedelic drugs
- 3 patent-pending new drug families drawing on novel chemical structures
- 75 compounds synthesized with preclinical data demonstrating promising results
- Patent pending Synthesis Process for psilocybin demonstrating clear benefits over current processes
- Accomplished and experience management & scientific team
Disclaimer: The author of this post does not hold an equity position in this stock. All data and information in this article has been sourced from publicly available documents such as investor presentations, industry publications & general web search. Investors are requested to conduct their own due diligence before taking any exposure to such stocks.