Positive top-line results from Phase IIa trial of SPL026 in Major Depressive Disorder
New SPL026 trials underway and screening commenced in the first in-human study of SPL028
Financial Highlights (including post-period events):
- Cash on hand as of
November 30, 2022 was$22.7 million . Cash is net of an unrealized foreign exchange loss of$2.3 million due to a strengthening of the Canadian dollar against the British pound sterling (“GBP”) during the 9 months endedNovember 30, 2022 ; however, as most of the Company’s operating costs are incurred in GBP, the loss has little impact on the underlying cash burn of the Company. - Cash used in operating activities was
$5.4 million for the three months endedNovember 30, 2022 . - Operating expenses for the three months ended
November 30, 2022 were$7.2 million . - 1,788,000 common shares purchased and cancelled to date through the normal course issuer bid.
Recent Operational Highlights (including post-period events):
Ultra Short-Duration Psychedelic Program
- Phase IIa trial investigated the safety and efficacy of intravenous (“IV”) SPL026, with supportive therapy, in 34 patients with moderate/severe Major Depressive Disorder (“MDD”). SPL026 demonstrated a rapid and durable antidepressant response, and a statistically significant and clinically relevant reduction in depressive symptoms versus placebo, as measured by the Montgomery-Åsberg Depression Rating Scale (“MADRS”).
- Primary endpoint met with a statistically significant -7.4 point difference between SPL026 (21.5mg) and placebo at two-weeks post-dose, as measured by MADRS change from baseline (p=0.02).
- Antidepressant effect of SPL026 with supportive therapy demonstrated a rapid onset at one-week post-dose with a statistically significant difference in MADRS of -10.8 versus placebo (p=0.002).
- Durable antidepressant effect with a 57% remission* rate at 12-weeks following a single SPL026 dose with supportive therapy.
- No apparent differences identified in antidepressant effect between a one and two dose regimen of SPL026.
- Favourable safety and tolerability profile demonstrated with no drug-related serious adverse events reported. All adverse events related to treatment were considered mild or moderate.
- Preparations for Phase IIb international multi-site clinical trial of SPL026 in MDD continues, with anticipated initiation in H1 2023.
- Dosing commenced in
December 2022 in Phase Ib drug interaction study which aims to assess the interaction between selective serotonin reuptake inhibitors (“SSRIs”) and SPL026 in patients with MDD. The open-label study will investigate the safety, tolerability, pharmacokinetics (“PK”), pharmacodynamics (“PD”) and exploratory efficacy of SPL026, alone or in combination with SSRIs.
Short-Duration Psychedelic Programs
- First patient dosed in
January 2023 in the Phase I study exploring intramuscular (“IM”) administration of SPL026. The study aims to compare the safety, tolerability, PK and PD of SPL026 delivered via IM versus IV administration in healthy volunteers. - Participant screening has commenced in the Phase I study evaluating the safety, tolerability, PK and PD of SPL028, deuterated DMT with supportive therapy.
Additional Activities
- SPL026 drug candidate to be provided in support of a
University College London (“UCL”) led neuroplasticity brain-imaging study, seeking to explore the impact of DMT-induced brain changes on cognition, behaviour, and well-being. The Understanding Neuroplasticity Induced byTryptamines Project (the “UNITy Project ”) will use Functional Magnetic Resonance Imaging (fMRI) to image the brain before, during and after a DMT or placebo infusion.
Corporate Activity
- Continued expansion of Intellectual Property portfolio with patents granted across each of the Company’s core areas of patent protection. Three new patents granted in fiscal Q3 increasing the total to 14 granted patents and over 90 applications pending, including:
- Second
U.S. patent granted, protecting the therapeutic composition of a small group of deuterated DMT compounds, with expected lifetime of exclusivity untilApril 2041 . - European patent granted protecting a manufacturing process for the preparation of synthetic DMT, DMT-related compounds and deuterated DMT analogs, including pipeline candidates SPL026 and SPL028.
- Second
- The Company has entered into a new services agreement dated
January 24, 2023 (the “Agreement”) withNative Ads, Inc. (“Native Ads”), pursuant to which Native Ads will primarily be tasked with providing content development, media buying and distribution, and campaign reporting services (collectively, the “Services”). The Agreement will commence on January 25, 2023, for an expected period of six months. Native Ads will receive a cash fee of USD$25,000 for the Services. The Company and Native Ads act at arm’s length and to the knowledge of the Company, Native Ads nor any of its directors or officers currently own any securities of the Company. Native Ads has agreed to comply with all securities laws and policies of theTSX Venture Exchange (“TSXV”) and the OTC Markets Group Inc. in providing the Services. No stock options or other securities-based compensation are being granted in connection with the Agreement. The Agreement remains subject to the prior acceptance and approval of the TSXV.
About the SPL026 in MDD Phase IIa study
The two-staged Phase IIa study investigated the efficacy and safety of IV SPL026, with supportive therapy, in 34 moderate/severe MDD patients. This included a blinded, randomized, placebo-controlled phase where the primary endpoint was to assess the efficacy of a single 21.5mg dose of SPL026 with supportive therapy, versus placebo with therapy, at two-weeks post-dose. All study participants were then enrolled into an open-label phase, where they received a single 21.5mg dose of SPL026 with supportive therapy, and were followed-up for a further 12-weeks. Efficacy was assessed using MADRS, a widely used and accepted scale for assessing depression severity, and assessments were made by blinded independent raters.
About
About Native Ads
Native Ads is a full-service advertising firm based in
Notes:
*remission = MADRS score ≤10
For further information contact:
Email: ir@smallpharma.co.uk
Tel: +1 (646) 751-4363
Investor Relations Contacts:
Email: eric@lifesciadvisors.com
Tel: +1 (646) 889-1200
Media Relations Contacts:
Email: smallpharma@mhpc.com
Tel: +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 anticipated impact of the results; impact of further analysis of the top-line SPL026 trial data on assumptions made based on top-line data; the anticipated commencement, timing and design of the Company’s Phase IIb international multi-site trial of SPL026; the Company’s Phase Ib drug interaction study assessing the interaction between SSRIs and SPL026 in patients with MDD, including the intended trial design and impact, the Phase I study exploring IM administration of SPL026, including the trial design and impact, the anticipated commencement, timing and design of the Phase I study of SPL028 evaluating deuterated DMT with supportive therapy; the provision of SPL026 to the
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.
The
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