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Small Pharma Inc. (DMTTF) is a pharmaceutical company focused on developing novel treatments for mental health disorders. With a strong emphasis on research and innovation, Small Pharma aims to revolutionize the treatment landscape for conditions like depression, PTSD, and anxiety.
The company's cutting-edge pipeline includes proprietary compounds that have shown promising results in preclinical studies. Small Pharma's approach prioritizes patient-centered care and strives to address the unmet needs of individuals suffering from mental health issues.
Small Pharma has established strategic partnerships with leading research institutions and experts in the field of psychiatry, ensuring a comprehensive and rigorous approach to drug development. The company's dedication to scientific excellence and patient well-being sets it apart in the competitive pharmaceutical industry.
Small Pharma Inc. (DMTTF) announced significant progress in its Phase IIa clinical trial of SPL026 for treating Major Depressive Disorder (MDD). The study met its primary endpoint with a statistically significant reduction in depressive symptoms of -7.4 points compared to placebo at two weeks (p=0.02). Notably, a rapid onset of effects was observed with a -10.8 point difference at one week (p=0.002). A 57% remission rate was reported at 12 weeks post-treatment. Safety profiles were favorable, with no serious adverse events. These findings support advancing to a Phase IIb multi-site study.
Small Pharma Inc. (TSXV: DMT, OTCQB: DMTTF) announced the upcoming release of top-line data from its Phase IIa trial of SPL026 for Major Depressive Disorder (MDD) on January 25, 2023. The results will be disclosed before market open, and a conference call will be held at 8:30 AM EST / 1:30 PM GMT on the same day to discuss the findings. SPL026 is a proprietary synthetic formulation of DMT and has received Innovation Passport designation from the U.K. Medicines and Healthcare products Regulatory Agency for MDD treatment. The company is advancing its clinical programs alongside developing a portfolio of preclinical assets.
Small Pharma Inc. has initiated a Phase I study comparing the safety and effectiveness of its proprietary psychedelic therapy, SPL026, administered intramuscularly (IM) versus intravenously (IV). This study, conducted in the UK, includes 14 healthy volunteers and aims to assess pharmacokinetics and pharmacodynamics, potentially improving treatment experiences for mental health conditions. Following the completion of a Phase IIa study for IV SPL026 in Major Depressive Disorder, results are expected shortly, guiding future clinical development.
Small Pharma Inc. has reached an important milestone in its clinical program with the completion of the last patient visit in the Phase IIa clinical trial of SPL026, a treatment for Major Depressive Disorder. Topline results are expected in early Q1 2023. Additionally, the company received a European patent for a synthetic manufacturing process of its DMT-related compounds, enhancing its intellectual property portfolio with a total of 14 granted patents. This patent enables scalable production, aiding in the commercialization of its pipeline candidates.
Small Pharma Inc. has initiated a Phase Ib study assessing the interaction between SSRIs and its lead candidate SPL026, a DMT-based therapy, in patients with Major Depressive Disorder. The study, involving up to 24 patients, will evaluate safety, tolerability, and efficacy of SPL026 alone and in combination with SSRIs that were previously ineffective. Results could facilitate patient recruitment for further trials. The company is also preparing for two additional clinical trials and completing follow-ups for its Phase IIa study by year-end, with results anticipated shortly thereafter.
Small Pharma will provide SPL026, a form of DMT, to support a University College London study examining psychedelic effects on cognition and brain function. The UNITy Project aims to uncover how DMT affects neuroplasticity over nine months using fMRI technology. Dr. Ravi Das, leading the project, emphasized the significance of understanding the mechanism behind psychedelic treatments for mental health. Small Pharma highlights its commitment to advancing treatment options for conditions like Major Depressive Disorder, backed by an Innovation Passport from the MHRA.
Small Pharma Inc. (TSXV: DMT; OTCQB: DMTTF) announces participation in the Canaccord Genuity Symposium on December 13, 2022. CEO George Tziras and Dr. Carol Routledge, Chief Medical and Scientific Officer, will join a panel discussing challenges in mental health therapeutics at 11:00 a.m. EST. The Company focuses on psychedelic-assisted therapies, particularly its lead candidate SPL026, a synthetic formulation of DMT for treating major depressive disorder (MDD), which has received Innovation Passport designation from the U.K. MHRA.
Small Pharma (TSXV: DMT, OTCQB: DMTTF), a biotechnology company focused on psychedelic-assisted therapies, announces its participation in two November conferences. At the Jefferies London Healthcare Conference from November 15-17, CEO George Tziras will engage in a fireside chat on November 16. The CNS Summit, taking place November 17-20 in Boca Raton, Florida, will feature Dr. Tiffanie Benway presenting SPL026 Phase I trial data on November 19. The company's lead candidate, SPL026, aims to treat major depressive disorder.
Small Pharma has received approval from the U.K. Medicines and Healthcare products Regulatory Authority for a Phase I study of SPL028, an injectable deuterated DMT candidate. The study aims to assess safety, tolerability, and pharmacokinetics in healthy volunteers, initiating in H1 2023. SPL028 targets a short psychedelic experience of over 30 minutes, potentially addressing unmet needs in mental health. Multi-layered intellectual property protection covers various jurisdictions, ensuring a robust foundation for further development.
Small Pharma has been granted patent no. 11,471,417 by the U.S. Patent Office as of October 18, 2022, enhancing its portfolio of short-acting psychedelic-assisted therapies. This patent protects therapeutic compositions of deuterated DMT compounds, extending exclusivity until April 2041. With this addition, Small Pharma now holds twelve patents and over 70 pending applications. CEO George Tziras noted significant advancements in their R&D and IP security, asserting confidence in their deuterated pipeline for mental health treatments.
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