MindBio Therapeutics Receives Final Regulatory Approval to Conduct Phase 2B Randomised Controlled Trial Microdosing Mb22001 in Patients Diagnosed with Major Depressive Disorder - Seite 2

In February 2024, MindBio completed its Phase 2a trial in patients with Major Depressive Disorder. In this open label trial, patients experienced a 60% drop in depressive symptoms and 53% of patients entering the trial with MDD, at week 8 were in complete remission from their depression marked by a mean 14.1 point drop in MADRS score (Montgomery-Asberg Depression Rating Scale). Prior trial results using MB22001 recorded statistically significant improvements in sleep quality and increases in subjective feelings of "Happiness", "Social Connectivity", "Energy", "Creativity" and "Wellness" with reduced "Anger" and "Irritability". MB22001 is a promising and potential market disruptive medicine for treating depressive illness.

The depth of data the company has collected is mounting evidence of the effectiveness and safety of MB22001 in treating depressive disorders at scale through take-home use. Extraordinarily, MindBio's unique investment thesis in the sector, is that small, sub-hallucinogenic doses of a psychedelic drug, MB22001 is the most scalable way to use a psychedelic medicine to treat depressive disorders globally. The methodology contrasts the major focus of pharmaceutical companies using large doses and lengthy expensive in-clinic hallucinogenic experiences coupled with extensive psychotherapy to treat these conditions. Whilst those methods are proving to be effective in clinical trials, it is disruptive to a patient's routine, requires time off work and the treatment is expensive potentially making it inaccessible at scale. MindBio's goal is to commercialise MB22001 as an affordable, accessible replacement to first line medications such as anti-depressants with low side effects (particularly no sexual side effects or weight gain) resulting in greater adherence.

MindBio is developing intellectual property in drug formulation and design for practical and safe take-home titratable use of MB22001. And, in a big data play for the company, MindBio is developing precision treatment regimens based on an individual's unique medical presentation. MindBio is the only organization in the world that has this type of data including extensive psychometric testing, mRNA, DNA, PK, PD, Biometric Markers, Activity Data and Sleep Data collected in the real world and approved by regulators for take home microdosing. Whilst the top line statistical reporting of data and the clinical trial protocols are shared openly and trial results published in peer reviewed scientific journals, the extensive data sets are proprietary and not visible or available for use by competitors. MindBio is building a defensive moat around its intellectual property including extensive data collection and analytics related to microdosing, with the ultimate view on competitively commercializing MB22001 directly against anti-depressants.