We’ve been following psychedelics studies updates coming out of the UK from a company called Small Pharma (TSXV: DMT.V OTC: DMTTF). Small Pharma is located in London, UK, and has been working with the DMT molecule on neuropsychiatric indications. The CEO, Peter Rands, was with us last month – you can catch his interview here – and today we’re pleased to welcome Small Pharma’s Chief Medical and Scientific Officer, Dr Carol Routledge, to The Dales Report.
Here’s some highlights from the first part of the interview:
Dr. Routledge brings 30 years of experience in pharmaceutical and biotechnology to Small Pharma
Dr. Routledge says that she has been a neuroscientist for nearly all of her career; she joined the field because she was inspired by a “brilliant neuroscientist lecturer in university,” and she wanted to follow that. Following obtaining her PhD in neuropharmacology, her first role was out in California, establishing a neuroscience department which did preclinical work.
Dr. Routledge’s career involved working in roles at big names such as Syntex, Wyeth, BTG and GlaxoSmithKline. But drug development and discovery was her passion, she says, and she also wanted to work for a small company. She was initially skeptical of the psychedelic space, but following her interview and meeting the team at Small Pharma, Dr Routledge became convinced that psychedelics was “a real, revolutionary way to treat depressive and anxiety disorders.”
Dr. Routledge believes that regulatory bodies help – and no longer hinder companies in the psychedelics space
At least when it comes to studying psychedelics, regulatory bodies seem to be helping more than hindering.
Regulatory authorities in the UK – the MHRA – and in Europe and the FDA are “moving with this field,” says Routledge. And it’s largely been what she describes as a positive experience. Dr. Routledge explains how Small Pharma sought scientific advice from the MHRA before they took DMT to their first clinical trial, the MHRA not only provided advice, they helped expedite to the clinic. The second time the MHRA was contacted regarding the phase 2b studies, they also offered some suggestions. There was “nothing that would indicate they don’t believe this could provide a really great treatment for depressive and anxiety disorders,” says Routledge.
She expects a similar experience with the FDA when Small Pharma seeks advice from them.
It doesn’t matter which country approves psychedelic use first, says Routledge
Phase 3 clinical trials are usually multi-site and multinational, she explains. Which means they’ll be performed in a number of locations globally.
When it comes to market authorization, a company can decide where to put the market authorization in first or in parallel, she admits. However she’s quick to point out that most companies go to the UK/Europe and the US in parallel, and she believes that all of these countries will ultimately have the same opinion and approval of this type of treatment.
Companies like Small Pharma bringing psychedelic treatments to market will change the healthcare system, says Routledge
Dr. Routledge admits that there are many different antidepression treatments and while they work only in a relatively small proportion of patients, there are many other areas that have similar efficacy rates, such as treatment for dementia.
Still, she points out, this leaves many patients untreated, and the ones that are treated by antidepressants like SSRIs often either relapse or cannot tolerate the side effects. “I think that’s what psychedelic assisted therapy brings along, a safer well tolerated medicine to patients,” she says.