World’s First Clinical Trial for DMT-Assisted Therapy in Major Depressive Disorder Shows Consistent Quality of Psychedelic Response in Phase I

Rhea-AI Summary

Small Pharma has announced positive findings from its Phase I trial of SPL026, a psychedelic-assisted therapy for Major Depressive Disorder (MDD). The trial, involving 32 participants, showed strong safety profiles with no serious adverse events and increasing quality in psychedelic experiences correlating with doses between 9mg and 21.5mg. Notably, participant-reported experiences improved dramatically with dosage, reaching scores up to 88 at the highest level. A Phase IIa study is on track for topline results in mid-2022, which could further validate these encouraging outcomes.

Positive

• No drug-related serious adverse events reported.
• Participant-reported experience scores increased significantly with dosage: 48 at 9mg to 88 at 21.5mg.
• Strong correlation between drug levels and psychedelic experience quality.
• Rapid clearance of SPL026 indicates potential for easy administration.

Negative

• None.

In the Phase I clinical trial, participants were administered SPL026 and underwent a 20-minute psychedelic experience

Phase I full dataset demonstrates consistent dose related effects on the intensity and quality of the psychedelic experience

LONDON, Feb. 22, 2022 (GLOBE NEWSWIRE) -- Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), a neuroscience company focused on psychedelic-assisted therapies for mental health, is pleased to share the analysis of Phase I data from the combined Phase I/IIa clinical trial of SPL026 with psychotherapy for the treatment of Major Depressive Disorder (“MDD”).

In the dose-escalating, placebo-controlled Phase I study, 32 healthy psychedelic naïve volunteers across four dose cohorts received either SPL026 in combination with psychotherapy (n=24) or placebo (n=8). This analysis provides additional insight into dose-related effects on the primary outcomes of safety and tolerability as well as on pharmacodynamic measures, including the treatment experience and subject well-being.

Dr. Carol Routledge, Chief Medical and Scientific Officer of Small Pharma said: “The analysis of the unblinded data set supports our choice to explore the antidepressant potential of our selected dose of SPL026 in the Phase IIa trial. Given the subjectivity of the psychedelic experience, it was exciting to see a close correlation between levels of drug in the body and pharmacodynamic endpoints. As for the subjects’ experience, most reported that it was pleasurable, not too challenging, and most importantly, nobody expressed any regrets. Additionally, the strong safety profile and rapid clearance of SPL026 from the body provides the potential for a scalable treatment with limited monitoring needs post dosing.”

Key results:

• No drug-related serious adverse events and minimal short-lived adverse events reported on dosing day.
• Of 20 drug-related adverse events, all were mild (85%) or moderate (15%) and resolved rapidly and independently.
• No statistically significant negative effects on anxiety and well-being identified at any point during the three-month follow-up.
• Data show a clear correlation between quality of psychedelic experience and dosing levels, starting at 9mg and up to 21.5mg, across all four cohorts.
  • Participant-reported scores, using a 0 to 100 scale, on the richness of the psychedelic experience demonstrated increasing values of 48 (9mg), 79, 79, 88 (21.5mg) across the four increasing doses. A dose correlation was seen across most patient-reported scores.
  • Therapist assessment of the predicted therapeutic benefit of SPL026 demonstrated a positive relationship with dose.
• In the majority of participants, there was a strong correlation between levels of N,N-dimethyltryptamine (“DMT”) in the body and the quality and intensity of the psychedelic experience.
• IV administration of SPL026 offers a short-lived, well-tolerated psychedelic experience of ~20 minutes, enabling a dosing session to last only ~30 minutes.
• Pharmacokinetic sampling supported rapid clearance out of the body, showing near undetectable DMT levels in the blood by 60 minutes at all investigated doses.
  

The data confirms the selected dose of SPL026 taken forward into Phase IIa most consistently delivers the target treatment profile across subjects through a multi-dimensional assessment including safety, tolerability, pharmacokinetic and pharmacodynamic parameters. The full dataset is anticipated to be published in a peer reviewed journal.

David Erritzoe of Imperial College London, Chief Investigator of the Phase I/IIa study said: “Psychedelic-assisted therapies have the potential to completely change the treatment paradigm of mental health conditions. The additional insights from Small Pharma’s Phase I study show promising results at this stage of the development. The dosing time of 30 minutes, in comparison with up to 6 hours seen with alternative approaches, has the potential to offer a real benefit in terms of treatment regimen for both patients and providers.”

The blinded, randomized, placebo-controlled, proof-of-concept Phase IIa study of SPL026 in combination with psychotherapy in 42 patients with MDD remains on track to deliver topline results in the first half of 2022. This study will assess the efficacy of one dose of SPL026 versus a placebo, and one versus two doses of SPL026 in combination with psychotherapy in patients with MDD while bolstering existing safety and tolerability data.

About Small Pharma

Small Pharma is a neuroscience company specialized in discovering and developing novel treatments for mental health conditions, with a focus on depression. Small Pharma initiated a clinical program into DMT-assisted therapy in February 2021. This program includes a Phase I/IIa trial on the Company’s lead candidate alongside development of a robust pipeline of proprietary preclinical assets.

About DMT

DMT is a naturally occurring psychedelic tryptamine found in plants and in the brain of mammals. Scientific evidence suggests DMT offers the potential for rapid-acting and long-lasting antidepressant effects. DMT is differentiated by its short psychedelic experience (< 30 mins), which allows for short treatment sessions and offers the potential for convenient supervised treatments within patient clinics. Small Pharma is advancing a pipeline of DMT-based therapies and is leading the world’s first DMT clinical trial for depression, in collaboration with Imperial College London.

For further information contact: 

Small Pharma Inc.

Peter Rands
Chief Executive Officer
Email: ir@smallpharma.co.uk
Tel:+44 (0)2071 129118

Investor Enquiries:
Eric Ribner, LifeSci Advisors
eric@lifesciadvisors.com

Tim Regan, KCSA Strategic Communications
tregan@kcsa.com

Media Enquiries
US
McKenna Miller, KCSA Strategic Communications
smallpharmapr@kcsa.com

Rest of World

Donna Curran, Hanover Communications
dcurran@hanovercomms.com

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 blinded, randomized, placebo-controlled, proof-of-concept Phase IIa study of SPL026, the Company’s selected dose of SPL026 in the Phase IIa trial, the publication of the Phase I full dataset in a peer reviewed journal, and the Company’s ability to develop solutions to effectively address depression through DMT-based therapies. 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 U.K. Medicines and Healthcare products Regulatory Agency (“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 (the “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.

FAQ

What are the results of Small Pharma's Phase I trial of SPL026?

Small Pharma's Phase I trial of SPL026 showed no serious adverse events and a strong correlation between doses and the quality of the psychedelic experience.

When will the Phase IIa study results for SPL026 be announced?

The topline results for the Phase IIa study of SPL026 are expected in the first half of 2022.

How did participants respond to the SPL026 treatment?

Participants reported pleasurable experiences with no regrets, and adverse events were mild and resolved quickly.

What is the dosing regimen and experience duration for SPL026?

The IV administration of SPL026 offers a psychedelic experience lasting about 20 minutes, with a total session time of approximately 30 minutes.