With Wonderland 2022 still fresh in our rear-view mirrors, let’s take a moment to look at some of the highlights from the big event. Pulling off such a massive undertaking wouldn’t be possible without the support of our sponsors, so we’ll start with MindBio Therapeutics, a Platinum Sponsor for Wonderland: Miami 2022.
MindBio Therapeutics is a clinical-stage drug development company pioneering microdosing research and advancing emerging therapies to treat a range of debilitating health conditions such as depression, anxiety, chronic pain, cognitive impairment, and PTSD.
Their flagship program is a Phase 1 clinical trial for Microdosing LSD. This May, MindBio completed its Phase 1 clinical trial, the largest safety study of its kind, a randomized, double-blind placebo-controlled study. The results were positive and MindBio is looking forward to analyzing the data from the Phase 1 clinical trial to further inform its planned Phase 2 clinical trials.
MindBio’s CEO Justin Hanka was at Wonderland, taking part in several panels and events:
- Press Lunch on November 3rd
- Microdosing with LSD panel on November 4th
- The Current State Of Clinical Trial Development panel on November 5th
At the Microdosing with LSD panel, Justin Hanka and Dr. Suresh Muthukumaraswamy, Associate Professor in Psychopharmacology (University of Auckland) presented the results of their Phase 1 trial of Microdosing LSD.
Mr. Hanka began with: “We believe microdosing will allow for scaling en-masse, getting treatments out in greater numbers for certain conditions. And LSD lends itself particularly well to microdosing”
“We are delighted by the positive data from Phase 1 clinical trials which is confirmatory for our investment in continuation Phase 2 clinical trials in patients suffering from Major Depressive Disorder which are due to start in the new year alongside a Phase 2 clinical trial in late stage cancer patients suffering existential distress.”
Dr. Suresh Muthukumaraswamy then presented details from their Phase 1 results. Highlights included:
- 1102 microdses (LSD/placebo) were administered in the trial with 100% adherence to regimen and no diversion of substances.
- Daily questionnaires showed credible evidence (>99% posterior probability) of increased ratings of “energy”, “wellness”, “creativity”, “happiness” and “connectedness” on dose days relative to non-dose days, which persisted when controlling for pre-intervention expectancy.
- Adverse Events (AEs): Analysis of AE data from all randomised participants (N = 80) shows the proportion of participants who experienced an AE in the LSD group was 85.0% and in the placebo group a very similar 80.0%. There were no deaths, serious or severe AEs in the study.
- Home-based microdosing studies have proven to be feasible and practical.
The company is now moving forward with protocols for its Phase 2a trial for microdosing, and is developing a Phase 2 clinical trial in late-stage cancer patients. This study will evaluate the feasibility of conducting a randomized controlled trial examining psychedelic-microdose assisted therapy alongside doses of either psilocybin or LSD, microdose or placebo.
For more on MindBio, visit their website here.