Cybin: Small Pharma data demonstrate efficacy/safety of DMT with SSRIs

Cybin commends Small Pharm “a biotechnology company focused on short-duration psychedelic-assisted therapies for mental health conditions, on its positive safety, tolerability and efficacy data from its Phase Ib study exploring the interaction between selective serotonin reuptake inhibitors and SPL026, native N, N-dimethyltryptamine in patients with Major Depressive Disorder or MDD . Doug Drysdale, Chief Executive Officer of Cybin, said: “With our upcoming acquisition of Small Pharma, we are excited to share its announcement of new data demonstrating that a DMT therapeutic is safe and enhances antidepressant efficacy in patients on SSRIs. This is impressive especially when combined with previously reported Phase IIa SPL026 efficacy data in MDD showing a rapid antidepressant effect and sustained remission to six months. Together, these results provide strong proof-of-concept and give us further reason to believe in the synergistic power of our combined programs, upon the closing of the transaction expected in the fourth quarter of 2023.” The purpose of the Small Pharma study was to build upon the previously reported Phase I/IIa safety and efficacy profile of SPL026 with support therapy, to assess whether SPL026 can be safely administered with or without SSRIs – the current standard of care for MDD. In the Phase I/IIa SPL026 study, patients were required to be withdrawn from SSRIs, which can be a disruptive experience. Through the SPL026-SSRI drug interaction study, Small Pharma aimed to address this requirement, which could enable broader patient recruitment on future large-scale studies, and potentially accelerate the clinical development pathway. Additionally, removing the requirement to be withdrawn from SSRIs may facilitate patient access to SPL026 earlier in the MDD treatment journey, if approved.