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As we approach the end of 2022, I’d like to take a moment to remind both shareholders and the broader investment community of Mindset’s recent achievements since our last update and express our excitement for 2023 and beyond.
The mindset is focused on a singular goal – to bring best-in-class optimized psychedelic medicine to patients in need. It is worth repeating why we believe this goal is important and achievable. Well-known classic psychedelic drugs, as shown by numerous clinical studies, appear to have significant potential to help patients suffering from neuropsychiatric disorders with unmet needs. These same drugs, however, are not fully optimized for therapeutic use by large groups of patients. New psychedelic drugs with improved duration, efficacy, and safety characteristics may better meet the needs of a broader segment of the neuropsychiatric patient population. In addition, because of their superiority and novelty, we believe that the new drugs will be more attractive to the pharmaceutical industry, whose support is necessary to develop these new drugs into an accessible and regulated segment of the psychedelic drug market.
At Mindset, we believe we can help achieve this goal by scientifically and methodically applying the tools of modern drug discovery—medicinal chemistry and behavioral pharmacology—to develop the next generation of psychedelic drug candidates that will better serve patients in need. This year, we made significant progress in advancing our rich pipeline of new drug programs to the clinical stage, expanded the frontiers of psychedelic drug discovery by developing new chemical classes, formed industry-leading partnerships, and continued to expand and enhance our scientific innovation and intellectual property portfolio.
All of our hard work has laid the groundwork for Mindset to move one or more of our new drug candidates into first-in-human clinical trials in 2023.
More programs are moving into the clinical phase
Accelerated clinical pathway for MSP-1014
MSP-1014 is a novel, rapidly metabolized, patent-pending prodrug of psilocin, the active metabolite of psilocybin, and is likely to have similar efficacy to psilocybin in improving depressive symptoms in difficult-to-treat patient populations. In extensive preclinical studies comparing MSP-1014 with psilocybin, MSP-1014 attenuated the reductions in locomotor activity and body temperature seen with psilocybin, suggesting that MSP-1014 may be better tolerated than psilocybin. Moreover, these improvements were evident in conjunction with an increased effect in assays that assessed cardinal signs of 5-HT2A target engagement.
In September, Mindset received positive scientific advice from the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) on a number of points to finalize its first-in-human clinical trial plan evaluating lead psychedelic drug candidate MSP-1014 for the treatment of major depressive disorder disorders (MDD). These guidelines will allow Mindset to significantly reduce the time and cost to advance to human clinical trials, bypassing the additional preclinical safety studies typically required for this clinical transition and allowing Mindset to move directly to treating patients. This first-in-human testing will allow Mindset to collect a valuable and broader range of human Phase 1b/2a clinical data in patients.
Selection of the head of the family 2: MSP-2020
“Family 2” of new drug candidates is characterized by a stronger effect compared to psilocybin, and preclinical data together suggest a shorter duration of effect than psilocybin. After extensive preclinical screening studies, the lead drug candidate, MSP-2020, and backup drug candidate, MSP-2003, were selected from Mindset’s Family 2 program in October and advanced to IND-enabling studies with a leading global contract research organization . (“CRO”), which represents a significant milestone in the development program of Family 2 for the company and its shareholders.
In head-to-head comparisons with psilocybin and psilocin, the two lead drug candidates elicit in vitro and behavioral responses consistent with a stronger and shorter psychedelic effect than psilocybin and a significantly reduced half-life. Two drug candidates are CNS penetrant and show high oral bioavailability in different species. They are being developed as optimized next-generation psychedelic drug candidates for the treatment of mental health disorders in collaboration with McQuade Center for Strategic Research and Development, LLC (“MSRD”), a member of the Otsuka family of pharmaceutical companies.
Leading industry partnerships
Mindset has an unrivaled track record of strategically partnering with organizations that can help us advance and commercialize our innovations. In addition to our existing partnership with Otsuka’s MSRD, in September Mindset announced an exclusive licensing agreement with Cibin Inc. (“Cybin”) whereby Cybin acquired intellectual property rights to a small subset of Mindset’s preclinical compounds related to our Family 1 portfolio, excluding MSP-1014 and related compounds. The agreement includes an initial payment by Cibin to Mindset of US$500,000, together with clinical development milestone payments, which could total up to US$9.5 million upon the successful completion of agreed upon milestones, including approval and commercialization of the first drug candidate, as well as sales royalties of approximately 2% for all commercialized licensed products under an exclusive agreement.
Complementing its new drug programs, Mindset has also developed a new, cost-effective manufacturing process for the synthesis of psilocybin. Mindset recently completed a large batch of cGMP (ie pharmaceutical grade) psilocybin with a leading international CDMO. In November, Mindset entered into an exclusive sales agreement with PharmAla Biotech Holdings Inc. (“PharmAla”), a biotechnology company focused on the research, development and production of MDXX-class molecules, including MDMA, to resell Mindset’s cGMP psilocybin under license to clinical investigators. PharmAla has a proven track record and sales infrastructure for selling pharmaceutical grade psychedelic compounds to the medical psychedelic research community.
Expansion of the new portfolio for the procurement of medicines
Mindset continues to apply insights from its drug discovery efforts to break new ground. Mindset’s state-of-the-art drug discovery approach enabled the identification of three additional families of highly novel, next-generation, non-tryptamine, psychedelic and non-psychedelic compounds with distinct pharmacological profiles. We have deliberately expanded our discovery efforts beyond tryptamines (psilocybin, DMT etc.) and into new, innovative and diverse chemical structures. These classes of non-tryptamine drugs are classified as families 6, 7 and 8 and these families are showing promising preliminary results so far. Over the past several years, we have developed a rich array of both tryptamine and non-tryptamine drug classes, and we are extremely excited to continue our research and innovation in our pursuit of innovative drug candidates.
Growing portfolio of intellectual property (“IP”).
Securing a strong intellectual property position is essential to our business strategy, and we strive to constantly strengthen and upgrade our portfolio. Currently, Mindset’s IP portfolio includes 15 patents and patent applications. In September, Mindset filed an additional 16 different national applications, covering the major markets of the Far East and North America, to protect our novel Family 1 and Family 2, next-generation psychedelics with different characteristics, including our clinical candidate, MSP-1014 and its backup MSP -1009.
Our recent achievements position Mindset for an even more exciting 2023 as we continue to make tremendous progress toward our ultimate goal of getting optimized medicines to patients. On behalf of the Mindset management team and the Board of Directors, I sincerely thank you for your continued support of the company and look forward to providing you with further updates as our progress continues.
With respect,
James Lanthier
CEO of Mindset Pharma
To watch a video of Mindset’s CEO and CSO discussing the announcement in more detail, visit: https://vvv.youtube.com/vatch?v=diR855K7aT8
About Mindset Pharma Inc.
Mindset Pharma Inc. is a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic drugs for the treatment of neurological and psychiatric disorders with unmet needs. The thinking was established to develop next-generation pharmaceuticals that harness the revolutionary therapeutic potential of psychedelic drugs. Mindset is developing several new families of next-generation psychedelic compounds, as well as an innovative process for the chemical synthesis of psilocybin in addition to its proprietary compounds. The company has a joint development agreement with the McQuade Center for Strategic Research and Development, a member of the Otsuka Pharmaceuticals family of companies, for its short-lived compounds, Mindset Families 2 & 4.
For additional information about Mindset, please visit our website at www.mindsetpharma.com.
For more information contact:
Investor contact:
Allison Soss
KCSA strategic communications
Email: MindSet@kcsa.com
Phone: 212-896-1267
,
Media contact:
McKenna Miller
KCSA strategic communications
Email: MindSet@kcsa.com
Phone: 949-606-6585
Company contact:
James Lanthier, CEO
Email: jlanthier@mindsetpharma.com
Jason Atkinson, Vice President, Corporate Development
Email: jatkinson@mindsetpharma.com
Phone: 416-479-4094
Forward looking information
This release contains certain “forward-looking information” within the meaning of applicable securities laws. Forward-looking information is often characterized by words such as “plan,” “expect,” “project,” “intend,” “believe,” “anticipate,” “estimate,” “may,” “will,” “would.” , “potential,” “proposed,” and other similar words, or statements that certain events or conditions “may” or “will occur.” These statements are predictions only. Forward-looking information is based on management’s opinions and estimates as of the date the information is provided and is subject to various risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. the future. information seeking. Additional information regarding risks and uncertainties related to the Company’s operations is provided under the heading “Risk Factors” in the Company’s annual information form for the financial year ended June 30, 2020 from March 5, 2021. The forward-looking information included in this news release is made as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking information to reflect new information, subsequent events or otherwise, except as required by applicable law. .
NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATORY SERVICE PROVIDER HAS REVIEWED OR ASSUME RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS PUBLICATION.
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