Small Pharma Announces SPL028 R&D Strategy Update

• Preliminary findings from ongoing Phase I trial of second-generation DMT asset SPL028 indicate the potential for a unique therapeutic profile 

• Proof-of-concept data from Company’s native DMT program, SPL026, offers potential for an expedited route to an international, multi-site Phase II study with SPL028 in 2024 

• Implementation of ongoing operational efficiencies including a reduction in headcount of approximately one-third

LONDON, July 05, 2023 (GLOBE NEWSWIRE) -- Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), 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.

George Tziras, Chief Executive Officer of Small Pharma, said: “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.”

Operational Efficiencies

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.

Contact Information:

Small Pharma Inc. & Investor Relations:
George Tziras, Chief Executive Officer
Email: ir@smallpharma.co.uk
Tel: +44 (0)7720 326 847

Media Relations:
Jenny Maguire, Head of External Affairs
Email: jenny.maguire@smallpharma.co.uk

Cautionary Note Regarding Forward Looking Statements
This press release contains statements that constitute “forward-looking information” (“forward-looking information”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward-looking statements in this news release include statements regarding the Company’s decision to expedite its clinical program of SPL028; the value proposition of SPL028, including the potential to provide efficacy for more patients with depression and for additional therapeutic indications compared to native DMT, optimized dose formulations for different administration routs based on the pharmacokinetic profile of SPL028; an anticipated short in-clinic treatment to offer a rapid and durable antidepressant response which enables a treatment to be delivered as required instead of a fixed treatment regimen, and the maximization of convenience for patients and physicians and provision of economic benefits for payers; statements related to the Phase Ib and Phase II studies of SPL028, including the decision to initiate the option of a Phase 1 patient study of injectable SPL028 in depression, and the implementation of, and anticipated timeline for, a multi-site, multi-jurisdiction SPL028 trial; the determination of the optimal development route for SPL028, including the target depression patient population; the implementation of operational efficiencies, including a headcount reduction of approximately one-third, and the impacts of same; the ability for SPL028 to offer a clinically distinct psychedelic treatment profile; the ability to deliver near-term and long-term value for shareholders and patients; and the Company’s ability to progress short-duration psychedelic assisted therapies for the treatment of mental health conditions.

In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. Known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Such factors include, but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting the Company’s business and results of operations; the impact of pandemics or other future disruptions; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.

Small Pharma makes no medical, treatment or health benefit claims about its proposed products. The MHRA or other similar regulatory authorities have not evaluated claims regarding DMT-assisted therapies and other next generation psychoactive compounds. The efficacy of such therapies has not been confirmed by MHRA-approved research. There is no assurance that such DMT-assisted therapies and other psychoactive compounds can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. Any references to quality, consistency, efficacy and safety of potential therapies do not imply that Small Pharma verified such in clinical trials or that Small Pharma will complete such trials. If Small Pharma cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Small Pharma’s performance and operations. 

The TSX Venture Exchange (“TSXV”) has neither approved nor disapproved the contents of this news release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.