UK Greenlights Phase 2 Clinical Trial On Mindset Pharma's Psilocin Drug For Major Depression

Drug discovery company Mindset Pharma MSSTF received approval from the U.K. Medicines and Healthcare Products Regulatory Authority (MHRA,) and the Research Ethics Committee, to begin a Phase 2 clinical study on the safety and efficacy of its novel psilocin prodrug for the treatment of patients with Major Depressive Disorder (MDD.)

See also: Psychedelics Company Takes 'A Key Step' With New Formulation Of Its Psilocin Prodrug For Anxiety

MSP-1014, a novel and patent-protected prodrug of psilocybin’s active metabolite psilocin, is thought to hold similar efficacy to psilocybin in improving depression symptoms while having superior tolerability, as shown in preclinical studies comparing the two.

To be conducted within the last quarter of this year, the two-part Phase 2 study will assess the safety and tolerability of up to three escalating doses of novel MSP-1014 in conjunction with Acceptance and Commitment Therapy (ACT.) Following, a randomized and placebo-controlled study will assess the safety and efficacy of a single dose of MSP-1014, selected from part 1, paired with 6 ACT sessions.

The next-gen psychedelic compound is derived from the company’s "Family 1," novel drugs that are accordingly “robustly” protected in several countries for the composition of matter IP.

Mindset’s CSO Joseph Araujo says the approval is an exciting milestone as the company prepares to enter what would be MSP-1014’s first clinical trial. 

“Based on preclinical data, we believe that MSP-1014 has the potential to be a better tolerated psychedelic therapeutic compared to psilocybin. This approval for a Phase 2 study should provide us with a strong efficacy signal and expedite our pathway to approval for MSP-1014 as a new effective and more tolerable treatment for patients suffering from MDD," Araujo said.

CEO James Lanthier echoed the enthusiasm, adding that the regulatory approval supports “a clear path” for MSP-1014 to become “one of the most clinically advanced psilocin-based Novel Chemical Entities (NCEs).” 

Lanthier sees that psilocybin’s clinical development advances are bringing about a significant expansion for novel optimized drug candidates. He added that “this announcement demonstrates that Mindset is delivering on its commitment to making the leap to becoming a clinical-stage biotech company focused on novel and patentable psychedelic-inspired therapeutics."

Photo: Benzinga edit with photo by Dana Creative Studio, PanuShot and Arif Vector on Shutterstock.