Mindset Pharma Inc (CSE:MSET, OTCQB:MSSTF) said it is finalizing its Phase 1 first-in-human clinical trial plan for its lead psychedelic drug candidate MSP-1014 for the treatment of major depressive disorder after receiving scientific advice from the UK Medicines and Healthcare products Regulatory Agency (MHRA).
MSP-1014 is Mindset’s novel and patented, second-generation psilocybin-like drug candidate which it is developing in collaboration with specialized UK-based contract research organization Clerkenwell Health.
According to the company, the MHRA has agreed with the company’s position and confirmed that, subject to CTA review, MSP-1014 will not require additional preclinical studies at this time.
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The regulator also provided specific valuable guidance on potential clinical trial design regarding dosing, patient selection criteria, and safety endpoints.
Mindset CEO James Lanthier said this favorable written guidance confirmed the readiness of MSP-1014 for Phase 1 first-in-human clinical development.
“We have been working diligently to advance MSP-1014 through the regulatory process and with this guidance, we have taken yet another essential step toward clinical trials and will not be required to conduct additional preclinical safety studies at this time, which removes costly and time-consuming steps,” Lanthier said.
“Moving our lead drug candidate forward to human trials will contribute to Mindset’s goal of reaching patients suffering from mental health conditions who are waiting for new medicines with meaningful benefits.”
Mindset is a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet needs.
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