Small Pharma is a neuropharmaceutical company that develops novel psychedelic treatments for mental health issues. The company, which is based in London, UK was founded in 2015 and became publicly listed on Toronto Venture Exchange (TSX) in Spring 2021.
Setting itself apart from the broader corporate psychedelic space focused on psilocybin, LSD, and related compounds, Small Pharma’s flagship project is SPL026, a fast-acting DMT-based drug that aims to treat depression. It is also developing “a pipeline of novel patent-protected deuterium-enriched tryptamine compounds,” including a deuterated DMT IV, an oral tryptamine, and a ketamine derivative. The drugs are intended for use in combination with psychotherapy. In an interview with Proactive, Small Pharma’s CEO Peter Rands explained that pursuing psychedelic treatment is “largely about efficacy. SSRIs have largely reached the limit of their potential [while] psychedelics are consistently showing efficacy in very refractory mental illness in the 70% range, which is enough of a difference to justify the investment.”
On its website, Small Pharma highlights DMT’s clinically practical 20-30 minute effect duration, its safety profile, and its “simple structure” that is conducive to laboratory manufacturing. In the company’s mission video, Chief Scientific and Medical Officer Dr. Carol Routledge stated, “DMT will provide that psychedelic experience which gives you the therapeutic benefit over a much shorter period of time.
What Small Pharma has also done is modify that molecule so that we can optimize completely that psychedelic experience, which in turn means you can optimize the antidepressant effects that DMT may have.” Dr. David Erritzoe, Clinical Psychiatrist at Imperial College London and Small Pharma Chief Investigator, said that psychedelic treatment “needs to be competitive in public health systems. It needs to be kind of cost-effective rather than having to go through a treatment session for many many many hours with therapists sitting around you. If a more condensed powerful experience could have therapeutic effects to the same level, that’s totally worth exploring.”
Small Pharma’s Phase I/IIa study began in Feb 2021 in collaboration with Imperial College London’s Centre for Psychedelic Research. The first trials are assessing the safety and tolerability of SPL026-assisted therapy; phase II trials will assess its potential to treat Major Depressive Disorder. Small Pharma’s website describes its trial protocol, which includes preparatory sessions, a single intravenous DMT dosage for a soundtracked hour-long session guided by two therapists, and follow-up integration sessions.
In the Proactive interview, Rands stated, “Right now, we’re seeing tolerability in our dose levels, which bodes well for the next stage.” The studies represent the most significant clinical investigations of DMT since its psychoactive properties were discovered by Dr. Stephen Szara in the 1950s. The history of DMT research is summarized in a Psychedelic Science Review article.