Mindset Pharma Meets With UK Regulator: Is A Phase 1 Trial Getting Close?

Biotech drug discovery firm Mindset Pharma Inc. MSSTF develops next-generation psychedelic and non-psychedelic medicines for neuropsychiatric and neurological disorders. To pursue their goal it received scientific advice from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) on several matters regarding the concretion of its first Phase 1 clinical trial plan evaluating the company’s lead psychedelic drug candidate, MSP-1014, for the treatment of major depressive disorder.

The meeting between the MHRA and Mindset focused on discussing the company’s plans for the Phase 1 trial of their second-generation psilocybin-like compound, to be developed in collaboration with specialized UK-based contract research organization Clerkenwell Health. 

The MHRA agreed with the company’s dispositions while also confirming that MSP-1014 would not require additional preclinical studies, provided it receives the national Clinical Trial Authorization.

Further, the agency provided scientific guidance on a potential clinical trial design in terms of dosing, patient selection criteria and safety issues.

As for the drug under study, MSP-1014 demonstrated greater efficacy and safety profiles, with reduced potential side effects, faster onset and similar duration of effect compared to the psilocybin in preclinical studies.

Mindset’s CEO James Lanthier expressed: “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,” he further explained.

The company expects that advancing their lead drug candidate forward to human trials “will contribute to Mindset’s goal of reaching patients suffering with mental health conditions who are waiting for new medicines with meaningful benefits.”

As for additional drugs under development, the company has recently discovered three novel non-tryptamine psychedelic compounds, constituting their Families 6, 7 and 8.

Photo courtesy of Olia Danilevich on Pexels.