Mindset Pharma Inc (CSE:MSET, OTCQB:MSSTF) CEO James Lanthier, has issued a letter to shareholders to highlight its current partnership with the McQuade Center for Strategic Research and Development (MSRD), a member of the global Otsuka family of pharma companies, and the company's clinical strategy and development progress across its pipeline of innovative compounds, which provide a de-risked path to the clinic.
“The partnership with MSRD is a major milestone, not only for Mindset but for the broader medical psychedelic industry,” noted Lanthier in the letter. “The fact that Mindset spearheaded the first partnerships with big pharma is a testament to our world-class innovations and quality of our science and rigorous drug development and validates our strategy for the second generation, optimized drug discovery approach.”
The partnership provides ongoing funding of development expenses needed to bring clinical candidates from Mindset's Families 2 and 4 of next-generation psilocybin and 5-MeO-DMT compounds, respectively, through Phase 1a and Phase 1b human clinical trials, and in addition, payment to Mindset in the amount of US$5 million.
READ: Mindset Pharma identifies new pharmacological insights of first-generation psychedelics through its COPE program with InterVivo Solutions
The collaboration supports both Mindset and Otsuka's mission to provide mental health solutions to a massive underserved population, Lanthier said.
In addition to the families 2 and 4 compounds, “we continue to evaluate and collect a strong critical data package for our psilocybin-inspired families 1 and 3 drug candidates,” Lanthier said.
In Family 1, the company has identified a lead drug candidate, MSP-1014, which is believed to be well-suited to address treatment-resistant depression and end-of-life cancer angst.
In preclinical studies, MSP-1014 has demonstrated an improved efficacy and safety profile compared to first-generation psilocybin, he said.
Due to its differentiated characteristics, it is considered a new chemical entity (NCE) and the company has developed a patent strategy to protect this asset.
“Early in 2022, we secured a leading contract manufacturer to produce pharmaceutical-grade batches of MSP-1014 for IND-enabling studies and subsequent human phase 1 clinical trials l,” Lanthier told investors. “While we continue collecting data, we are pursuing development partners to support the clinical process.”
In Family 3, Mindset identified compounds that have the potential to treat a range of mental health disorders in the form of daily, take-home medications. The preclinical data suggests that a range of doses may be sub-hallucinogenic doses, and the company plans to examine this class of compounds for pro-cognitive benefits.
“The ability to provide pro-cognitive solutions without a psychedelic effect will suit vulnerable patient populations such as juvenile ADHD, Alzheimer's disease, and a range of other psychiatric disorders,” Lanthier said.
The company also welcomed Dr Fiona Randall, as senior vice president of external alliances and scientific strategy to support the company's partnership strategy. Mindset's drug development program is led by its chief scientific officer, Joseph Araujo.
Contact Ritika at ritika@proactiveinvestors.com