Small Pharma Inc. (TSXV: DMT / OTCQB: DMTTF), a biotechnology company focused on short-duration psychedelic-assisted therapies for mental health conditions, is pleased to announce a research and development (R&D) strategy update, aimed at expediting its clinical program of SPL028, the Company’s novel deuterated N, N-dimethyltryptamine (“DMT”) compound with multi-layered intellectual property (“IP”) protection.
SPL028 is currently dosing in an ongoing Phase I study in healthy volunteers. Preliminary findings from the first two cohorts demonstrate that intravenous (“IV”) SPL028 elicits a psychedelic experience of <1 hour and is well-tolerated. SPL028 is based on the following target value proposition:
- Distinct DMT-based therapeutic profile: An extended DMT psychedelic experience of up to ~1 hour may provide efficacy for more patients with depression, and for additional therapeutic indications, compared to native DMT. Additionally, the pharmacokinetic (“PK”) profile of SPL028 may enable optimized dose formulations for different administration routes.
- Strong commercial proposition: An anticipated short in-clinic treatment (~<2.5hr dosing with therapy) offering a rapid and durable antidepressant response, as supported by the SPL026 Phase IIa data, enables the potential for a treatment that is delivered episodically on an “as required” basis, rather than via a fixed treatment regimen. This may maximize convenience for both patients and physicians, as well as provide economic benefits for payers.
- Robust IP protection: SPL028 has a multi-layered IP portfolio, including Composition of Matter protection in multiple jurisdictions, and protection surrounding related deuterated compounds.
Development of the SPL028 program is informed by data from the Company’s clinical trials of SPL026, Small Pharma’s native DMT compound. The Company showed clear proof-of-concept with SPL026 for the treatment of Major Depressive Disorder in a Phase IIa trial. This was the first placebo-controlled study to demonstrate the clinical efficacy of a DMT-based therapy, indicating a rapid and durable antidepressant response in many patients until at least six months. Further, the PK profiling of IV and intramuscular (“IM”) SPL026 through the Phase I studies has been critical in informing dose selection for the active Phase I SPL028 study. Topline data from the SPL028 Phase I healthy volunteer study is anticipated in Q4 2023.
The Company anticipates that the combined data from the SPL026 and SPL028 programs could enable an expedited path to initiating a multi-jurisdiction, multi-site Phase II study in 2024. Accordingly, the Company’s protocol for the SPL028 Phase I program includes the option of initiating a Phase Ib patient study of injectable SPL028 in depression. Determination of the optimal development route for SPL028, including the target depression patient population, will be reviewed following the conclusion of the ongoing Phase I studies.
“We are encouraged by the data from our clinical programs, which enables us to explore expediting the development of SPL028. Insights generated from our studies give us confidence that SPL028 may offer a clinically distinct psychedelic treatment profile. Combined with a strong and maturing IP portfolio and a promising commercial proposition, we believe that expediting the SPL028 program strengthens the Company’s position to deliver near and long-term value for shareholders and patients.”
George Tziras, Chief Executive Officer of Small Pharma
As part of the Company’s ongoing exercise to enhance operational efficiencies and focus efforts on achieving key value-based milestones, the Company is implementing a headcount reduction of approximately one-third. Dr. Alastair Riddell will also leave his role as Chief Operating Officer (“COO”). Ms. Marie Layzell, the Company’s current Chief Manufacturing and Development Officer and previous COO, will assume the additional responsibilities of COO alongside her current role.
Mr. Tziras commented: “Our prudent decision to evaluate each role in our organization against our core value-driving activities moving forward has resulted in a reduction in the members of our team. I want to extend my gratitude to each team member impacted by this decision for their dedication and important contributions to Small Pharma. I would also like to thank Dr. Alastair Riddell for his unique contributions in helping us optimize our operational processes given his deep experience in building and scaling biotech companies.”
About the SPL028 Phase I Clinical Trial
SPL028 is Small Pharma’s proprietary deuterated DMT candidate with multi-layered patent protection. The Company initiated the first-in-human Phase I clinical trial with SPL028 in Q1 2023. The study is a randomized, blinded, placebo-controlled, dose-escalating study evaluating the safety, tolerability, pharmacodynamics and pharmacokinetics of both IV and IM administration of SPL028 in healthy volunteers.
About Small Pharma
Small Pharma is a biotechnology company progressing a pipeline of short-duration psychedelic-assisted therapies for the treatment of mental health conditions. Small Pharma has a portfolio of clinical-stage DMT-based assets, SPL026 and SPL028. The Company was granted an Innovation Passport designation for SPL026 from the U.K. Medicines and Healthcare products Regulatory Agency (the “MHRA”) and has a pipeline of proprietary preclinical assets.