Friday, May 13, 2022
Mindset Pharma Inc., a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet medical needs, today announced that it is making headway in progressing its Family 1 lead clinical candidate, MSP-1014, towards clinical trials. Recently, the Company engaged a UK-based Contract Research Organization (CRO), Clerkenwell Health, to prepare for an initial scientific meeting with regulators to discuss the company’s initial plans for clinical development.
“At Mindset, we are working diligently to advance MSP-1014 through the regulatory process as quickly as possible. We have selected an expert CRO, Clerkenwell Health, to lead the initial scientific discussions with the regulators in the UK as we start to pull together our clinical plans. We’re invigorated by this next step and look forward to providing updates along the way,” said James Lanthier, CEO of Mindset.
MSP-1014, Mindset’s Family 1 lead candidate, in preclinical studies demonstrated an improved efficacy, with reduced potential side effects, and safety profile compared to first-generation drug candidate psilocybin. Given its improved pharmacological profile in preclinical models, Mindset has prioritized moving MSP-1014 to first in human (FIH) studies to confirm human safety, pharmacokinetic profiles and the effective human dose range. If MSP-1014 data translates, Mindset will have one of the first novel psychedelic drugs in human clinical trials with the potential to treat mood disorders, including major depressive disorder, substance misuse disorders and end-of-life angst associated with terminal illnesses, including cancer. The Company is in the process of manufacturing 1kg of pharmaceutical grade product to move into IND-enabling studies and subsequent human clinical trials as early as 2023.
Joseph Araujo, Chief Scientific Officer at Mindset, confirmed, “In a side-by-side comparison, our extensive preclinical data shows there is clear differentiation from psilocybin. We are excited to move this drug candidate forward as quickly as possible to human trials to confirm that this data translates into meaningful benefits for patients who are waiting for new medicines.”
Mindset continues to perform studies across various preclinical models with MSP-1014, from its Family 1, and its library of next-generation psychedelic compounds to show the differentiation of their novel drug candidates and to build a catalog of translational data as they prepare for human clinical trials. Mindset is developing several novel families of next-generation psychedelic compounds, as well as an innovative process to chemically synthesize psilocybin as well as its own proprietary compounds. The Company is working with Otsuka’s McQuade Center for Strategic Research and Development on its Families 2 & 4.