Mindset Pharma will receive scientific advice from UK regulators to help advance the Phase 1 First-In-Human clinical trial plan for lead clinical candidate MSP-1014. The Canadian Business Journal

TORONTO, September 14, 2022 (GLOBE NEWSWIRE) — Mindset Pharma Co., Ltd. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) (“Mindset” or “Company”)is a drug discovery company developing novel and optimized next-generation psychedelic and non-psychedelic drugs for the treatment of neuropsychiatric and neurological disorders with unmet medical need. announced that it has received scientific advice from the Care Products Regulatory Agency. MHRA”) discusses the various points to finalize a Phase 1 first-in-human clinical trial design evaluating the lead psychedelic drug candidate MSP-1014 for the treatment of major depressive disorder (MDD). I’m here.

In a meeting with MHRA, Mindset collaborated with specialist Psychedelics UK to plan Phase 1 first-in-human development of MSP-1014, a novel and patented second-generation psilocybin-like drug candidate within Family 1 We talked about Clerkenwell Health, a contract research organization (CRO) based in The MHRA agreed with our position and confirmed that, subject to CTA review, MSP-1014 does not require additional preclinical studies at this time. The MHRA also provides specific and valuable guidance on potential clinical trial designs regarding dosage, patient inclusion criteria, and safety endpoints.

Preclinical studies have shown that MSP-1014 has an improved efficacy and safety profile, fewer potential side effects, a faster onset of action, and similar efficacy compared to the first-generation drug candidate psilocybin. The effect was shown to persist. Given its differentiation and improved pharmacological profile, Mindset prioritized moving his MSP-1014 into first-in-human clinical trials.

“We are thrilled to receive this favorable written guidance from the MHRA confirming that MSP-1014 is ready for first-in-human Phase 1 clinical development. We have worked diligently to advance MSP-1014 through the regulatory process, and with this guidance, we are taking another important step towards clinical trials and conducting additional preclinical safety studies at this time. No. Mindset Pharma CEO James Lanthier said: “Advancing our lead drug candidates into clinical trials is an important step in helping the mental health community await new drugs with meaningful benefits. It contributes to Mindset’s goal of reaching patients suffering from the condition.”

About Mindset Pharma Co., Ltd.
Mindset Pharma Inc. is a drug discovery and development company focused on creating optimized, patentable, next-generation psychedelic medicines to treat unmet neurological and psychiatric disorders. A mindset has been established to develop next-generation pharmaceutical assets that exploit the breakthrough therapeutic potential of psychedelics. In addition to its own compound, Mindset is developing several new families of next-generation psychedelic compounds, as well as an innovative process to chemically synthesize psilocybin. The company has a co-development agreement with the He McQuade Center for Strategic Research and Development, a member of the Otsuka Pharmaceutical family of companies, for Mindset Family 2 and 4, short-term compounds.

For more information on Mindset, please visit our website at www.mindsetpharma.com.

For more information, please contact:

Investor Contact:
Alison Soth
KCSA Strategic Communications
Email: [email protected]
Phone: 212-896-1267

Media contact:
mckenna miller
KCSA Strategic Communications
Email: [email protected]
Phone: 949-606-6585

Company Contact:
James Lanthier, CEO
Email: [email protected]

Jason Atkinson, Vice President of Corporate Development
Email: [email protected]
Phone: 416-479-4094

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