In a recent press release, Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF), a drug discovery company specializing in developing innovative psychedelic and non-psychedelic medications for neuropsychiatric and neurological disorders, announced that it has received approval from the U.K. Medicines and Healthcare products Regulatory Authority (MHRA) and the Research Ethics Committee to initiate a Phase II clinical trial of MSP-1014. The trial will evaluate the safety and efficacy of MSP-1014, a novel psilocin prodrug, for the treatment of major depressive disorder (MDD). This exciting milestone marks a significant step forward in Mindset’s mission to provide more effective and tolerable treatments for patients suffering from MDD.
MSP-1014 Phase II Trial: Exploring Safety and Efficacy
The Phase II study will be conducted in two parts, each focusing on different aspects of MSP-1014 and its therapeutic potential for MDD.
Part 1: Safety and Tolerability Assessment
In the first part of the trial, Mindset will evaluate the safety and tolerability of up to three escalating doses of MSP-1014. Study participants will receive MSP-1014 in conjunction with Acceptance and Commitment Therapy (ACT), a form of psychotherapy known to be effective in treating various mental health conditions.
Part 2: Randomized and Placebo-Controlled Study
The second part of the trial will be a randomized and placebo-controlled study. Mindset will assess the safety and efficacy of a single dose of MSP-1014, selected based on the findings from Part 1. An equal number of patients will receive MSP-1014 or a placebo, and all participants will undergo six sessions of ACT.
Understanding MSP-1014: A Novel Psilocin Prodrug
MSP-1014 is a patent-protected prodrug of psilocin, the active metabolite of psilocybin. It is designed to provide similar efficacy to psilocybin in improving depressive symptoms while potentially offering better tolerability. Promising preclinical studies comparing MSP-1014 to psilocybin suggest that MSP-1014 may be better tolerated by patients, providing an opportunity for a more patient-friendly psychedelic therapeutic.
Joseph Araujo, Chief Scientific Officer of Mindset, expressed excitement about entering the first-in-human clinical trial with MSP-1014, stating that they believe MSP-1014 has the potential to be a better tolerated psychedelic therapeutic compared to psilocybin. This Phase II study approval will not only demonstrate the drug’s efficacy but also expedite its pathway to becoming an effective and more tolerable treatment for patients with MDD.
CEO’s Perspective: A Major Regulatory Milestone
James Lanthier, Chief Executive Officer of Mindset, emphasized the significance of this major regulatory milestone. He stated that with the approval of the Phase II trial, MSP-1014 now has a clear path to become one of the most clinically advanced psilocin-based novel chemical entities (NCE). As psilocybin continues to show promise in clinical development, the opportunity for novel and optimized drug candidates, like MSP-1014, is expanding significantly.
Lanthier also highlighted that this milestone demonstrates Mindset’s commitment to becoming a clinical-stage biotech company focused on developing patentable psychedelic-inspired therapeutics. MSP-1014, derived from Mindset’s “Family 1” of novel drugs, enjoys robust intellectual property protection in multiple jurisdictions, separate from the company’s collaboration with the McQuade Center for Strategic Research and Development.
Mindset Pharma’s announcement of receiving approval for a Phase II clinical trial evaluating MSP-1014 for the treatment of major depressive disorder marks an important milestone in the development of novel and optimized psychedelic medications. With the potential for improved tolerability compared to psilocybin, MSP-1014 offers hope for more patient-friendly treatments. The upcoming trial will provide crucial data regarding the safety and efficacy of MSP-1014, bringing Mindset Pharma one step closer to delivering effective and patentable psychedelic-inspired therapeutics for patients with unmet medical needs. For more information about Mindset Pharma and its drug development programs, visit their official website at www.mindsetpharma.com.
For more information, please contact:
James Lanthier, CEO
Jason Atkinson, VP, Corporate Development
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