MindBio Therapeutics Corp. has announced a significant milestone in its Phase 2B clinical trial evaluating MB22001, a microdosing formulation of Lysergic Acid Diethylamide (LSD), in advanced-stage cancer patients experiencing anxiety and depression. The company has dosed the 20th participant, reaching the halfway point in the study, which is designed to assess the efficacy of MB22001 in conjunction with Meaning-Centred Psychotherapy (MCP).
The double-blind, randomized trial involves 40 patients who will receive seven sessions of MCP alongside 13 doses of either MB22001 (4ug-12ug) or a placebo. The primary objective is to determine whether MB22001 can enhance the therapeutic effects of MCP in alleviating anxiety and depression in this vulnerable population.
Addressing Unmet Needs in Cancer Care
Anxiety and depression are common in advanced cancer patients, often leading to despair, hopelessness, and a diminished quality of life. While pharmacotherapeutic interventions like antidepressants are frequently used, meta-analyses have shown limited efficacy in this specific population. Meaning-Centred Psychotherapy (MCP) has emerged as a promising approach to improve meaning and quality of life, but MindBio posits that combining MCP with MB22001 will yield superior outcomes.
Prior Clinical Data Supports MB22001 Potential
MindBio's confidence in MB22001 is underpinned by four years of data collection and analysis from previous clinical trials. These studies have demonstrated improvements in mood, a 60% reduction in depressive symptoms, enhanced sleep, and increased feelings of creativity and energy following an eight-week treatment course with MB22001. Secondary outcome measures also revealed a 52% reduction in anxiety (HAM-A), along with self-reported reductions in stress (35%), anxiety (59%), and depression (40%) as measured by the DASS questionnaire. Furthermore, participants experienced a 37% improvement in psychological quality of life, as indicated by the WHOQOL.
Safety and Tolerability
Crucially, safety analyses have consistently shown a favorable adverse event profile for MB22001, with a low frequency of adverse events and no clinically significant abnormalities observed in follow-up blood tests, electrocardiograms, or echocardiograms. Tolerability is a paramount consideration when treating vulnerable patients in the advanced stages of cancer.
Regulatory Strategy and Future Outlook
MindBio's commercial strategy involves targeting global special access schemes, such as Health Canada’s Special Access Program (SAP) and Australia’s Special Access Scheme (SAS) and Authorised Prescriber (AP) schemes, assuming positive results from the Phase 2B trial. These schemes allow registered health practitioners to access unapproved therapeutic goods for patients under their care.
"We are delighted with the progress of our cancer trials as we continue to dose patients in multiple Phase 2B programs," said Justin Hanka, Chief Executive Officer of MindBio. The company anticipates sharing top-line data from the trial in 2025.
