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Highlights
- MindBio Therapeutics reports no serious adverse events in its Phase 2B trials for depression and cancer-related distress.
- The independent safety audit clears both trials to continue toward completion in late 2025.
- MB22001, a non-hallucinogenic psychedelic drug, shows promise as a scalable alternative to antidepressants.
MindBio Therapeutics Corp. (CSE: MBIO); (Frankfurt: WF6) is a clinical-stage biopharmaceutical company focused on the development of psychiatric medicines using microdoses of psychedelic compounds. The Company’s primary research is aimed at utilizing the non-hallucinogenic potential of psychedelics to treat complex psychiatric disorders, such as Major Depressive Disorder (MDD) and end-of-life distress related to advanced-stage cancer.
In its ongoing Phase 2B clinical trials, MindBio has achieved a significant milestone with the results of an independent safety audit. The safety review was conducted midway through the trials, which are studying the effects of MB22001, a form of lysergic acid diethylamide (LSD), in both MDD patients and individuals facing cancer-related psychological distress. The findings were promising, revealing no serious adverse events or side effects in the participants, which allowed the trials to move forward without interruption.
Currently, MindBio is conducting two landmark Phase 2B trials:
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A trial involving 90 patients diagnosed with Major Depressive Disorder. This is a rigorous triple-blind, double-dummy, active placebo-controlled study designed to test the efficacy and safety of MB22001.
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A second trial with 40 patients suffering from advanced-stage cancer and associated mental health challenges, such as anxiety and depression. This study is a double-blind, placebo-controlled trial assessing MB22001 as an adjunct to Meaning Centred Psychotherapy, a standard form of mental health care for end-stage cancer patients.
The independent safety audit results are a testament to the rigorous safety standards and practices that MindBio upholds. The Company’s commitment to patient safety is reflected in the successful monitoring and tracking of doses administered at home. Utilizing proprietary technology, MindBio ensures that patients adhere to their treatment regimens while also allowing clinicians to monitor patient data 24/7. These measures allow for unprecedented levels of patient autonomy, as participants are legally able to administer the psychedelic medicine themselves in the community setting, a first for clinical trials of this kind.
Justin Hanka, Chief Executive Officer of MindBio, expressed his optimism, stating, "We are very pleased with the outcome of this mandatory independent safety audit of our clinical trials. While we won’t know the outcome of the trials until late 2025, this is a very good sign that side effects are not a problem with our lead candidate drug MB22001 and we can confidently continue our work."
The successful continuation of these trials is crucial as MindBio seeks to position MB22001 as a scalable, non-hallucinogenic alternative to traditional antidepressant medications, which often come with challenging side effects. The promise of MB22001 is in its ability to treat complex psychiatric conditions with minimal risk of side effects, a breakthrough that could significantly impact the global mental health treatment landscape.
MindBio is on track to complete its Phase 2B trials in late 2025, marking a potential turning point in the use of psychedelic medicine for psychiatric care.
