Justin Hanka | Co-Founder, MindBio Therapeutics

What first got you excited about psychedelics and their therapeutic potential?

‍My business partner and I are investment bankers by trade and we look at hundreds of new investment opportunities every year. We came across psychedelics rather unintentionally via our auditors who explained what was happening in this space.  We spent some time learning about the benefits of psychedelics and it wasn't long before we became fascinated by the incredible potential of psychedelics to structurally change the brain, not just change its neurochemistry. We were hearing reports that psychedelics could represent as close to a cure as you might get for some mental health conditions.  It was hard to believe but from the outset we were drawn into this exciting business of psychedelics and so we founded MindBio Therapeutics with a vision to be a world leader developing novel treatments for mental health conditions.

What is MindBio working on?

MindBio has several pillars of research and product development underway.  These include interests in:

Drug and formulation development.  We are developing microdose formulations using LSD (lysergic acid diethylamide) and psilocybin

Clinical trials. MindBio is more than half way through a Phase 1 clinical trial microdosing LSD in 80 patients in a world first clinical trial of its kind where patients are prescribed LSD in microdoses to patients who take the drug at home.  MindBio has a fully funded Phase 2 clinical trial in late stage cancer patients in development and a Phase 2 clinical trial in Major Depressive Disorder due to kick off in the second half of 2022.

Psychedelic assisted psychotherapies in a clinic setting. We are collaborating with our sister company Trip Pharma and their Leichtmind clinics (leichtmind.com) to develop clinician assisted psychedelic therapies.

Digital Interventions for better mental health - Through our sister company Digital Mind Technology (digitalmindtechnology.com) we are conducting clinical trials in late stage cancer patients experiencing pain and at risk of depression and anxiety.

Wearables and devices to deliver psychedelics and monitor their effects on patients.   We are developing a safety anti-tampering medicine delivery device that can be used to dispense psychedelic medicines along strict treatment regimens and in doing so, help prevent abuse and misuse of the drug and we are also developing wearables and devices to monitor the effects of psychedelic treatment and to optimise dosing regimens.

What psychedelic molecules are you investigating and for which indications?

We have a broad interest across psychedelics but specifically we are interested in the potential of microdosing LSD and psilocybin. Both drugs are indicated for depression, anxiety and many related health disorders.

Can you share with us what potential LSD holds as a molecule for therapeutic purposes and what validation you have seen of it clinically?

LSD is indicated in the treatment of a number of medical conditions including Major Depressive Disorder, Anxiety and Chronic Pain.  These are conditions we are specifically interested in targeting.  Our clinical trials will be used to determine the safety and efficacy of taking these drugs in microdoses.  LSD is known to be longer acting in smaller doses so it is a good candidate for our microdosing trials.  

Why does operating in New Zealand create a favorable regulatory environment for MindBio?

The NZ government has provided grant funding and approvals for our clinical trials to import LSD, manipulate the drug in a laboratory and prescribe the drug to patients who take it with them at home in the same way they would take any other medication.  This is a world first clinical trial of its kind where the clinical trials are being conducted in a community setting and due to the global restrictions on the experimentation and use of LSD there are very few jurisdictions around the world like we have in NZ, with our current approvals where this kind of trial would be possible.  The regulatory approvals allow us to trial the drug in real world circumstances, not just in a laboratory.

Dr. Lahiru Russell from Digital Mind Technology was recently appointed as a medical advisor. Can you explain how this relationship will impact and benefit MindBio?

Dr Russell is conducting clinical trials using digital interventions to improve mental health outcomes in patients being treated with cancer.  Dr Russell's clinical trials integrate well with our fully funded Phase 2 clinical trials microdosing psychedelics in late stage cancer patients experiencing distress.  The collaborative opportunities are numerous in this regard and we are excited by the expertise and novel thinking in mental health that Dr Russell can bring to our business.

What trend do you think is emerging in the world of psychedelics and what impact do you see that having?

One of our early observations which surprised us is just how well that psychedelics in this new renaissance and acceptance of the drugs have been received by the community, governments around the world and the medical sector.  The science is advancing very quickly and our understanding of the benefits of psychedelics in the treatment of depression and other mental health disorders makes the case for new treatments using these substances compelling.

What obstacles do psychedelic-focused companies need to overcome in the near future to be medically accessible and be able to help patients?

We believe that robust clinical research and clinical trials that proves the drugs are safer and more effective than the existing treatment regimens for treatment of depression, anxiety, pain and related disorders is the key to medical, community and government acceptance.  Until clinical trials work their way through the approval processes, access to approved psychedelic medicines looks to be limited to special access schemes or government approvals in limited circumstances and limited jurisdictions.  We are also seeing decriminalization for personal use of psilocybin in some jurisdictions which opens access to treatment options, however MindBio is interested in the scalable and legal medicinal use of the drug that is guided by qualified medical practitioners.