Small Pharma Announces Positive Six-month Data from Phase IIa Trial of SPL026

LONDON, April 04, 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, today announces positive six-month data from the Company's Phase IIa clinical trial of SPL026. In the study, patients with Major Depressive Disorder ("MDD") received SPL026, the Company's proprietary, pharmaceutical-grade formulation of N,N-Dimethyltryptamine ("DMT"), during a clinical session with supportive therapy. New data from the Phase IIa trial shows that among the patients who had achieved remission within three months with SPL026, 64% sustained remission to six months.

The trial investigated the efficacy and safety of 21.5mg intravenous ("IV") SPL026 with supportive therapy in 34 patients with moderate/severe MDD. The study was conducted in two stages. The first stage consisted of a blinded, randomized, placebo-controlled two-week phase where the primary endpoint was to assess the efficacy of a single dose of SPL026 with supportive therapy. In the second open-label phase, all study participants received SPL026 treatment, and were followed-up for a further three months in study.

Patients continued to be followed up out-of-study to six months following the open-label dose, enabling further assessment of durability of antidepressant effect, using the Montgomery-Asberg Depression Rating Scale ("MADRS"). A total of 25 patients from both treatment arms (single and two dose regimen) completed the six-month patient follow-up.

Of the 25 patients who completed the six-month patient follow-up:

• 14 patients had initially achieved remission¹ within the three-month in-study period (the "Prior Remitters")
• 9 of the Prior Remitters (64%) sustained remission at six-months
• Overall, 10 of the 25 patients (40%) met the criteria for remission at six-months
  

The chart below sets out aggregated remission rates^a at one week to six months post open-label dose, demonstrating the remission rates of patients over time:

^{Note: n = number of datapoints
(a) Aggregated data includes all participants who received either one dose or two doses of SPL026; and includes four participants excluded from the formal statistical analysis who received a blinded dose of SPL026 but did not receive a second open-label dose.}

Dr. Carol Routledge, Chief Medical & Scientific Officer said: "With our ongoing analyses of the Phase IIa trial data, we are increasingly encouraged by the treatment potential of SPL026. A single dose in conjunction with therapy demonstrated a rapid and robust antidepressant effect after one week. This new data shows that the antidepressant effect was sustained for six months in two-thirds of patients who were in remission at an earlier time-point in the study. As we finalize the design of the Phase IIb study, this data helps to inform our understanding of treatment durability and our approach to patient retreatment within the trial."

George Tziras, Chief Executive Officer of Small Pharma said: "We are pleased to see that participants in our study experienced durable relief from their depression for an extended period of time. Given these clinical outcomes from one or two treatments, this could further offer potential value to healthcare systems that face challenges with patients who struggle to adhere to their daily antidepressant use."

Robin Carhart-Harris PhD, Director of the Psychedelics Division at the Weill Institute for Neurosciences at the University of California San Francisco, and Ralph Metzner, Distinguished Professor of Neurology, Psychiatry and Behavioral Sciences commented: "This data indicates that SPL026 can elicit a fast-acting antidepressant response that appears to be enduring in several cases. Recent neuroimaging and preclinical findings imply a regenerative action with DMT and other related serotonergic agonists."

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. The Company's current focus is on exploring new therapeutic approaches for depression. Small Pharma's lead candidate, SPL026, is a proprietary synthetic formulation of DMT. The Company is advancing clinical programs of SPL026 and SPL028 with supportive therapy for the treatment of mental health conditions, and was granted an Innovation Passport designation from the U.K. Medicines and Healthcare products Regulatory Agency (the "MHRA") for IV SPL026 with supportive therapy for MDD. In addition, Small Pharma has a pipeline of proprietary preclinical assets in development.

References:
¹ Remitters/remission: patients with MADRS score ?10

For further information contact:

Small Pharma Inc.
George Tziras, Chief Executive Officer
Email: [email protected]
Tel: +44 (0)7456 915968

Media Relations Contacts:
Jaber Mohamed
MHP Communications
Email: [email protected] 
Tel/text: +44 (0)7720 326 847

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 Phase IIa study of SPL026, including the six-month data informing the Company's understanding of treatment durability and approach to patient retreatment in the Phase IIb trial design; the impact of the data on the Company's future clinical strategy and expansion of its clinical pipeline; the potential value of mental health treatments to healthcare systems and patients suffering from depression and struggling with antidepressant use, including the Company's ability to provide such treatments; 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 COVID-19; 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.

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