- First patient dosed in phase IIa of Small Pharma’s (DMT) DMT-assisted therapy clinical trial
- The first of 42 patients with MDD have now been dosed in the blinded, randomized, placebo-controlled, proof-of-concept Phase IIa study
- The Phase IIa portion of the Phase I/IIa study will assess the efficacy of one versus two doses of SPL026 in combination with psychotherapy in patients with MDD
- Efficacy will be assessed using the Montgomery-Asberg Depression Rating scale to measure any potential reduction in the patients’ depression
- Small Pharma is a neuropharmaceutical company specialized in IP-led development of novel treatments for mental health conditions
- Small Pharma Inc. (DMT) is up 8.06 per cent, trading at C$0.34 at 1:15 pm ET
Small Pharma Inc. (DMT) has dosed the first patient of its Phase IIa clinical trial for its lead N,N-dimethyltryptamine candidate, SPL026.
In combination with psychotherapy, SPL026 is intended to serve as a possible treatment of Major Depressive Disorder.
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.”
“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,” concluded Routledge.
The first of 42 patients with MDD have now been dosed in the blinded, randomized, placebo-controlled, proof-of-concept Phase IIa study of SPL026 in combination with psychotherapy.
The Phase IIa portion of the Phase I/IIa study, 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, while furthering Small Pharma safety and tolerability dataset.
Efficacy will be assessed using the Montgomery-Asberg Depression Rating scale to measure any potential reduction in the patients’ depression. Topline results are anticipated in the first half of 2022.
Small Pharma is a neuropharmaceutical company specialized in IP-led development of novel treatments for mental health conditions, with a focus on depression.
DMT is a naturally occurring psychedelic tryptamine found in plants and in the brain of mammals. Scientific evidence suggests DMT offers the potential for rapid-acting and long-lasting antidepressant effects.
Small Pharma Inc. (DMT) is up 8.06 per cent, trading at C$0.34 at 1:15 pm ET.