More than 300mln people globally suffer from depressive disorders that could be assisted by such treatments
() announced the expansion of its Phase I/IIa clinical trial for its lead product, a DMT-based treatment for major depressive disorder.
Hammersmith Medicines Research is leading the blinded, two-part Phase I/IIa clinical trial of SPL026, a DMT fumarate.
Earlier in the year a Phase I study was started to demonstrate the safety and tolerability of different dose levels of SPL026 in psychedelic-naïve subjects when compared to placebo.
Phase IIa, the patient proof of concept, will assess the efficacy, safety and tolerability 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 the severity of depressive episodes.
MAC Clinical Research has been appointed to expand the Phase IIa trial with an additional study site in Liverpool, UK, which will bring the total number of patients in the Phase IIa trial to 42 when it begins in the third quarter of 2021.
As a result of appointing MAC, Small Pharma said the timeline for the Phase I/IIa clinical trial are expected to accelerate with anticipated top-line results brought forward to the first half of 2022 from the end of 2022 previously.
Peter Rands, chief executive of Small Pharma, said: “MAC’s extensive good clinical practice experience, expertise and infrastructure will provide access to additional sites designed for clinical trials such as ours.”
Chief medical and scientific officer Carol Routledge said: “With more than 300 million people globally suffering from depressive disorders, new treatments cannot come soon enough. Psychedelic-assisted therapy studies consist of drug treatment in combination with psychological therapy which require specialist facilities that can host both elements. MAC brings expertise in conducting clinical trials for psychedelic-assisted therapy along with appropriate facilities within Prescott. This enables faster throughput of patients to assess the impact of this much needed treatment for patients suffering with depression.”
Psychedelics have been shown to have therapeutic benefits in ‘internalizing disorders’ such as depression, substance abuse and post-traumatic stress disorder, which are characterized by recurring negative thoughts.
Clinical research suggests that DMT can break or disrupt the pathways in the brain that underlie these negative thought processes. By doing so, such treatments can work well in combination with therapy.