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Small Pharma Inc. (TSXV: DMT, OTCQB: DMTTF) announces promising six-month results from its Phase IIa trial of SPL026 for treating Major Depressive Disorder (MDD). According to the results, 64% of trial participants who achieved remission within three months maintained their remission at the six-month follow-up. The trial involved 34 patients, assessing the effects of a 21.5mg IV dose of SPL026 combined with supportive therapy. This data informs the future clinical strategy and potential treatment approaches for MDD, indicating SPL026's sustained antidepressant effect and its potential value in healthcare systems.
Small Pharma, a biotechnology company focused on psychedelic-assisted therapies, is hosting a virtual roundtable on March 15, 2023, at 2:00 p.m. EDT. Dr. Jerry Rosenbaum from Harvard and Dr. David Erritzoe from Imperial College will discuss the potential of short-duration psychedelic treatments for depression. The event will highlight Small Pharma’s positive Phase IIa results for its lead candidate, SPL026, a synthetic DMT formulation, in treating Major Depressive Disorder. This study was the first to show the efficacy of a short-duration psychedelic in therapy, providing valuable insights for psychiatrists.
Small Pharma Inc. (OTCQB: DMTTF) has announced positive results from its Phase IIa trial of SPL026, designed to treat Major Depressive Disorder (MDD). The trial, which involved 34 patients, demonstrated statistically significant reductions in depression and anxiety symptoms. Key findings include a p-value of 0.002 for depression and 0.03 for anxiety at two weeks post-dose. Notably, improvements in wellbeing were also observed, with a mean change of 10.1 compared to 0.9 in the placebo group. Dr. Carol Routledge noted the potential for SPL026 to address anxiety-related disorders, while CEO George Tziras highlighted the $1 trillion economic impact of depression. Full trial results are forthcoming.
Small Pharma Inc. (TSXV: DMT, OTCQB: DMTTF) has announced participation in Cowen’s 43rd Annual Health Care Conference from March 6 to 8, 2023, at the Boston Marriott Copley Place. CEO George Tziras and Dr. Carol Routledge will represent the company. A cocktail reception will be held on March 7, featuring guest speaker Dr. Jerry Rosenbaum from Harvard Medical School. The company focuses on psychedelic-assisted therapies, particularly for mental health conditions. Its lead candidate, SPL026, is a synthetic formulation of DMT, currently in clinical development for Major Depressive Disorder.
Small Pharma Inc. (TSXV: DMT, OTCQB: DMTTF) has initiated a Phase I clinical trial for SPL028, a deuterated DMT candidate, involving both intravenous and intramuscular administration routes. This first-in-human study aims to evaluate the safety, tolerability, and pharmacokinetics of SPL028, which is designed to provide an extended psychedelic experience tailored for diverse mental health conditions. Early preclinical results indicate that SPL028 may offer a safety profile comparable to the lead candidate SPL026. The trial is being conducted at MAC Clinical Research in Manchester, England, and represents a critical step in Small Pharma's development of innovative psychedelic-assisted therapies.
Small Pharma announced the issuance of two new U.S. patents, enhancing its intellectual property portfolio to a total of 16 granted patents and over 90 applications pending. These patents pertain to deuterated compounds of DMT and therapeutic compositions for mental health treatments. George Tziras, CEO, highlighted the importance of a robust IP position in the company's mission to innovate therapeutic solutions. The patents will provide significant protections for the SPL026 and SPL028 candidates, which are under development for Major Depressive Disorder. The announcement follows positive results from a Phase IIa trial, further strengthening the company’s position in the market.
Small Pharma has reported positive results from its Phase IIa trial of SPL026, demonstrating a significant reduction in depressive symptoms in patients with major depressive disorder (MDD). Key findings include a statistically significant -7.4 point difference from placebo at two weeks post-dose (p=0.02) and a 57% remission rate at 12 weeks. The company is also advancing its clinical programs, with preparations for a Phase IIb trial planned for H1 2023 and a new Phase Ib study on drug interactions with SSRIs. Financially, as of November 30, 2022, Small Pharma had $22.7 million in cash, while operating expenses were $7.2 million for the quarter.