We are developing psilocybin therapy to help people who have mental health challenges, including treatment-resistant depression. To make sure it is safe and effective in patients, psilocybin therapy needs to be approved by medical regulators, not legislators.
To do this, we have to run large-scale clinical trials to generate data to show the therapy works and is safe. Only then will it be approved by regulators, and become part of the healthcare system, prescribed by doctors and funded by national bodies, payers or insurers.
We are committed to delivering socially responsible science. We want to bring this innovation to patients as quickly as possible, but in a way that prioritises safety, efficacy, quality, and accessibility. Our focus is on patients in need – there are 100 million people suffering with treatment-resistant depression and the mental health care system doesn’t work for most of them. We want to do something about that, and the fastest and most effective route is through the regulatory system.