Biotech drug discovery company Mindset Pharma Inc. MSTF develops next-generation psychedelic and non-psychedelic medicines for neuropsychiatric and neurological disorders. To pursue her goal, she received scientific advice from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to several matters regarding the substantiation of its first phase 1 clinical study plan Evaluation of the Company’s lead psychedelic drug candidate, MSP-1014 for the treatment of major depressive disorder.
The meeting between MHRA and Mindset focused on discussing the company’s plans for their company’s Phase 1 trial Second generation psilocybin-like compoundto develop Cooperation with the specialist British contract research organization Clerkenwell Health.
The MHRA concurred with the company’s orders while confirming that MSP-1014 would not require additional preclinical studies pending national approval Clinical Trial Approval.
Further, The agency provided scientific guidance for a possible clinical trial design in terms of dosing, patient selection criteria and safety issues.
As for the drug under study, MSP-1014 showed better efficacy and safety profileswith reduced potential side effects, faster onset and similar duration of action compared to psilocybin in preclinical studies.
Mindset CEO James Lanthier expressed, “We are thrilled to have received this positive 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 get MSP-1014 through the approval process and With this guidance we have taken another important step towards clinical trials and do not currently need to conduct any additional pre-clinical safety studies. eliminating costly and time-consuming steps,” he continued.
The company expects that advancing its lead drug candidate into human trials “will help…
Read full story here https://www.benzinga.com/markets/cannabis/22/09/28868604/uk-regulator-hints-next-gen-psychedelics-company-on-how-to-begin-clinical-trial-of-novel-psilocy