Mindset Pharma Inc. (CSE: MSET) (OTC: MSSTF) announced that they received Scientific Advice from the UK Medicines and Healthcare products Regulatory Agency (MHRA) on a range of points to finalize its Phase 1 first-in-human clinical trial plan evaluating its lead psychedelic drug candidate MSP-1014 for the treatment of Major Depressive Disorders (MDD).
In a meeting with the MHRA, Mindset discussed its plans for Phase 1 first-in-human clinical development of MSP-1014, a novel and patented, second-generation psilocybin-like drug candidate within Family 1, in collaboration with a specialized psychedelic UK-based Contract Research Organization (CRO), Clerkenwell Health. The MHRA has agreed with Mindset’s position and confirmed that, subject to CTA review, MSP-1014 will not require additional preclinical studies at this time. The MHRA has also provided specific valuable guidance on potential clinical trial design regarding dosing, patient selection criteria, and safety endpoints.
In preclinical studies, MSP-1014, demonstrated an improved efficacy and safety profiles, with reduced potential side effects and faster onset of action, and similar duration of effect compared to the first-generation drug candidate psilocybin. Give its differentiation and improved pharmacological profile, Mindset prioritized moving MSP-1014 to first-in-human clinical studies.
James Lanthier, CEO of Mindset Pharma, commented on their plans:
“We are thrilled to have received this favorable written guidance from the MHRA, confirming 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.”
Mindset Pharma is a market awareness client of Capital 10X.
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