Psychedelics biotech Small Pharma Inc. DMTTF confirmed that the first patient has been dosed in its Phase 1b study assessing the interaction between selective serotonin reuptake inhibitors (SSRIs) and proprietary lead DMT candidate SPL026 in patients with Major Depressive Disorder (MDD).
The open-label study is being conducted at two MAC clinical research sites in the U.K.
It will evaluate the safety, tolerability, pharmacokinetics (PK,) pharmacodynamics (PD) and exploratory efficacy of SPL026, whether alone or combined with SSRIs.
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More specifically, the trial will assess a single dose of SPL026 in up to 24 patients currently on a treatment course of SSRIs that have been ineffective in fully relieving their depression, compared to patients who are not currently using any approved drug treatment for depression. Importantly, all patients will receive SPL026 paired with supportive therapy.
Small Pharma CMO and CSO Carol Routledge explained that should the SSRI drug interaction study now underway provide encouraging results, this could potentially facilitate patient recruitment in additional trials by removing the requirement for patients to be withdrawn from their existing SSRI medication and, “in the longer term, successful results could expand patient access to SPL026 therapy.”
CEO George Tziras added that the company is approaching the end of 2022 “with plenty of momentum as we prepare to initiate two additional clinical trials,” while also expecting to complete patient follow-ups in the SPL026 Phase 2a study by the end of this year and topline results following thereafter.
Photo courtesy of Pavel Danilyuk on Pexels and Harbin on Wikimedia Commons.
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