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Small Pharma’s Phase IIa DMT-assisted therapy begins

Published on 21/10/21 at 09:31am

Small Pharma has announced that the first patient has been dosed in the company’s Phase IIa clinical trial for its lead N,N-dimethyltryptamine (DMT) candidate, SPL026, which will serve as a possible treatment of Major Depressive Disorder (MDD) in combination with psychotherapy.

The first of 42 patients with  MDD have now been dosed in the blinded, randomised, placebo-controlled Phase IIa study. The Phase IIa portion of the Phase I/IIa study is being held at two UK clinical trial sites – Hammersmith Medicines Research and MAC Clinical Research – will assess the efficacy of one versus two doses of SPL026 in combination with psychotherapy in patients with MDD.

Small Pharma is a neuropharmaceutical company, specialised in creating novel, innovative treatments for mental health conditions, specialising in depression. The company is leading the world’s first clinical trial for DMT-assisted psychedelic therapy in major depression, in collaboration with Imperial College London.

DMT is a naturally occurring psychedelic tryptamine, found in plants and in the brain of mammals. Evidence gathered so far has supported that DMT has potential for antidepressant effects. The drug also has a shortened psychoactive experience of approximately 30 minutes or under – significantly less than other medical psychedelics such as psylocybin, which has a psychoactive experience of roughly eight hours.

Dr. Carol Routledge, Chief Medical and Scientific Officer of Small Pharma noted: “the world’s first regulated clinical trial for DMT-assisted therapy targeting MDD is underway and we continue to make rapid progress. This is a key study for our DMT-assisted therapy portfolio as we assess the effectiveness of our lead candidate to treat MDD.

“There has been strong interest in trial recruitment to date, as such, we expect reporting of topline results to remain on track for the first half of next year. We believe that DMT-assisted therapy has the potential to offer a new therapeutic treatment for MDD, a disorder that devastates the lives of millions of people every year.”

Lina Adams


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