European Patent Grant Strengthens Small Pharma’s Ketamine-based Patent Portfolio For The Treatment Of Depressive Disorders
Patent provides protection for oral dosage forms of ketamine-based preclinical candidate, SPL801B, as a sole treatment and in combination with a serotonin modulator
LONDON, Oct. 25, 2021 — Small Pharma Inc. (TSXV: DMT) (the “Company” or “Small Pharma”), a neuropharmaceutical company focused on psychedelic-assisted therapies, today announced that it has received European patent grant number EP 3 463 323 as acceptance for its European patent application No. 17 728640.8. The patent grants certain protections for oral dosage forms of a range of 2R,6R-hydroxynorketamine (“6-HNK”) based compounds, including the Company’s preclinical candidate SPL801B, for the treatment of depressive disorders.
Peter Rands, Chief Executive Officer of Small Pharma, said:
We continue to experience rapid maturation both in our corporate profile and the progression of our pipeline of therapeutic candidates. Securing the patent rights to SPL801B, our preclinical ketamine-based candidate for the treatment of depression, allows us to securely investigate its commercial potential. This is the third patent to be granted in our growing IP portfolio which protects the Company’s rights to innovate and develop novel treatment candidates for mental health conditions.”
The European patent office has determined the patentability of the novel dosage forms of 6-HNK, an active ketamine metabolite. The European patent also provides protection for a solid oral dosage form of SPL801B for administration, in combination with a serotonin modulator, for use in the treatment of depressive disorders. Early preclinical studies of SPL801B have shown signs of potential antidepressant effects without the psychoactive effects typically associated with ketamine.
Small Pharma is a neuropharmaceutical company specialized in IP-led development of novel treatments for mental health conditions, with a focus on depression. Small Pharma initiated a clinical program into N,N-dimethyltryptamine (“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.
SPL801B is a proprietary drug substance based on 6-HNK which is an active metabolite of ketamine. Scientific evidence suggests 6-HNK offers the potential for rapid antidepressant effects and may deliver an improved side effect profile to ketamine as an antidepressant.
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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 potential for 6-HNK to deliver rapid antidepressant effects and an improved side effect profile to ketamine as an antidepressant, the Company’s ability to securely investigate the commercial potential of SPL801B, the Company’s ability to innovate and develop novel treatment candidates for mental health conditions through ketamine-based candidates, 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 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.
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