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New findings on safety, tolerability and efficacy from a clinical study assessing the interaction of psychedelics and traditional pharma for the treatment of major depressive disorder (MDD) are out.
They correspond to U.K.’s short-acting psychedelic therapies developer Small Pharma’s (OTCQB:DMTTF) open-label Phase 1b study assessing the joint work of its “native” DMT compound, SPL026 and selective serotonin reuptake inhibitors (SSRIs.)
The trial studied the safety, tolerability, pharmacokinetics and pharmacodynamics (PK/PD) and exploratory efficacy of one 27.5 mg IV infusion of SPL026, both alone and in combination with SSRIs in 17 patients paired with support therapy, as follows:
The test cohort had 12 patients on a stable -and insufficient- SSRIs treatment course, while the control cohort had 5 patients not using any pharmacological treatment for their depression symptoms. Patients were recruited with moderate to severe MDD.
SPL026 was well-tolerated by all 17 patients, with no apparent differences between both cohorts and no drug-related serious adverse events reported.
A total of 11 mild or moderate drug-related adverse events (AEs) were reported in both groups (8 in the SSRI cohort, 3 in the non-SSRI group) the majority of them resolved during the dosing visit.
Results reaffirmed SPL026’s efficacy (shown in a prior Phase 2a study) in the non-SSRI cohort, yet the treatment showed “marked,” greater antidepressant effects in the SSRI cohort, suggesting a “potentially enhanced efficacy effect” when administered jointly with SSRIs.
While the prior Phase 1/2a trial assessed the safety and efficacy profile of SPL026 paired with support therapy alone, the fact of not requesting MDD patients to drop their SSRIs would expectedly enable broader patient recruitment for future, large-scale SPL026 studies, accelerate its clinical development, and facilitate patient access earlier within their therapeutic journey, if approved.
CMO Dr. Carol Routledge said that while the team was “very pleased” to find patients may not need to withdraw from their SSRIs, they were not expecting to see “such a marked difference in efficacy” when administering SPL026 in combination with SSRIs compared to SPL026 alone.
“The potentially enhanced efficacy effect of a DMT-based treatment when administered with SSRIs could lead to greater therapeutic benefit for patients, and a compelling argument for positioning it earlier in the treatment pathway. This was a small study, but the findings are both interesting and encouraging and warrant further exploration,” Routledge explained.
CEO George Tziras added that these safety and tolerability results “further support” Small Pharma’s DMT programs’ patient access strategy, and further stated the team looks forward to exploring these findings “as part of the integrated DMT program with Cybin (NYSE:CYBN), subject to completion of the proposed arrangement transaction.”
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Photo: Benzinga edit with photo by Bacsica, aiyoshi597, Gisele Yashar and Gorodenkoff on Shutterstock.
