MindBio Therapeutics

About

MindBio Therapeutics is pioneering clinical studies into the microdosing of psychedelic medicines to treat a range of medical conditions such as depression, anxiety, PTSD, panic disorder, chronic pain and opiate addictions.

They invest in clinical research to discover potential new treatment options and we aim to create novel medicines and treatment regimes from breakthrough microdosing studies.  

Phase I clinical trials are underway at the Medical and Health Sciences School of Pharmacy at the University of Auckland in New Zealand to determine the effectiveness of microdosing Lysergic Acid Diethylamide (LSD) for treating depression.

Phase 2 clinical trials have just been approved for microdosing of LSD in late stage cancer patients.  This study will evaluate the feasibility of conducting a randomised controlled trial comparing psychedelic-microdose assisted – Meaning Centred Psychotherapy to standard Meaning-Centred Psychotherapy in people who have advanced cancer and anxiety or depression. Participants will be randomised to receive psychotherapy alongside doses of either an LSD microdose or placebo. The feasibility, acceptability, safety and potential psychological benefits of this intervention will be assessed. Our findings will inform the development of a larger trial and provide initial indication of potential benefits of psychedelic microdosing in advanced cancer.

Highlights

Sept 2021 Blackhawk Growth Corp (CSE:BLR) Acquires MindBio Therapeutics 

Developing Microdosing Therapies to Treat Mental Health Conditions Using Psychedelic Formulations  

Started Phase 1 LSD Microdosing Clinic Trials for depression 

Phase 2 LSD Microdosing Clinical Trials for Cancer patients approved 

Trials conducted by The University of Auckland 

World Class Research Team 

New Zealand Government Grants - $845,844 

Minister of Health – Regulatory Approval 

Approval for patients to self administer drug at home 

Approved Import License

Unique Microdosing Trals

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In its first approved microdosing study, the University is conducting a randomised controlled trial of repeated microdoses of LSD under schedules similar to those suggested in the grey literature. 

80 healthy volunteers will be randomised to receive repeated doses of either inactive placebo or LSD (10 µg oral) under double-blind conditions in a parallel groups design. 

A variety of physiological and psychological measures will be recorded at baseline and after completion of each of a six-week dosing regimen. 

Measures will include a validated personality scale and tests of creativity. Electroencephalography will be used to directly measure brain function in each participant before and after treatment. 

Results of the study will enable a rigorous evaluation of the purported benefits of psychedelic microdosing and will be relevant to the question of whether microdosing may be a viable alternative treatment regimen for depression, where full psychedelic doses are currently being investigated in clinical trials.

Anti-tampering & Dose  

Monitoring Device.

Wearables 

• Monitor physiological, psychological and cognitive activities 

• Accurately capture and predict clinical outcome/treatment responders 

• Individualize dosing and schedule for optimal treatment results 

Oral Formulations 

• An LSD microdosing formulation for home use 

Digital Applications 

• Data collection 

• Deep learning algorithms 

• Patient – doctor communication and monitoring 

• Biomarker development and precision diagnosis 

Real World Testing of dispensing and delivery solutions 

MindBio Therapeutics is interested in developing novel drug formulations, prescription and dispensing and drug delivery solutions. The New Zealand regulatory framework allows home dosing by study subjects. The clinical trial provides an opportunity to testa variety of safe delivery and monitoring technologies for use in the real world.

Regulatory Approvals – Phase 1 LSD  Clinical Trial Approved and Underway. 

The clinical trial protocols were published in advance of data collection 2. Trials  Started in April 2021. The trial is registered on the Australian New Zealand  Clinical Trials Registry 1.  

Scientific Title  

A randomised, double-blind, placebo-controlled trial to study the effects of  repeated microdoses of lysergic acid diethylamide (LSD) on creativity and brain  activity in healthy adult males. 

• There is a growing microdosing subculture and grey literature suggesting  that this practice can enhance creativity and productivity, Improve mood  and favourably modify personality traits. 

• These classified effects are similar to those observed in clinical studies, in  which participants receive much larger, perception-altering doses of LSD or  psilocybin. Currently there are no controlled, scientific studies of the psychological or physiological effects of repeated psychedelic home-self administered microdosing. 

Regulatory Approvals – Phase 2 LSD Clinical Trial Approved in Cancer Patients

The Phase 2 LSD microdosing trial in cancer patients has just been approved and a  $250,000 grant provided by the New Zealand Ministry of Health1. 

Summary 

The administration of high-dose psychedelic compounds have shown clinically  significant benefits in the treatment of psychological distress in advanced cancer  patients. However, psychedelics at high doses can vividly alter perceptions; an  experience that poses challenges in this vulnerable population. ‘Microdosing’ – repeated administration of psychedelics in low doses does not alter perceptions  but may offer similar benefit in reducing anxiety, depression and existential  distress. This study will evaluate the feasibility of conducting a randomised  controlled trial comparing psychedelic-microdose assisted – Meaning Centred  Psychotherapy to standard Meaning-Centred Psychotherapy in people who have  advanced cancer and anxiety or depression. Participants will be randomised to  receive psychotherapy alongside doses of either an LSD microdose or placebo. The  feasibility, acceptability, safety and potential psychological benefits of this  intervention will be assessed. Our findings will inform the development of a larger  trial and provide initial indication of potential benefits of psychedelic microdosing in advanced cancer.