<a href="https://www.benzinga.com/markets/cannabis/22/10/29294614/small-pharmas-q2-2023-financial-results-ultra-short-acting-psychedelic-program-underway">Small Pharma Inc</a>. DMTTF, a biotech company that develops&nbsp;short-acting psychedelic-assisted therapies for depression,&nbsp;received approval from the U.K. Medicines and Healthcare products Regulatory Authority (MHRA) and the Research Ethics Committee to begin a Phase 1 clinical study of its deuterated form of DMT, SPL028.

&ldquo;Progressing our second candidate towards the clinic marks a significant step for Small Pharma. Our focus continues to be in evaluating short-acting psychedelic therapies due to their potential as scalable treatments, which we see as critical given the magnitude of the mental health crisis,&rdquo; CEO George Tziras stated.&nbsp;

The randomized, placebo-controlled, blinded,&nbsp;dose-escalating study will&nbsp;be conducted at MAC Clinical Research in Manchester, England starting in the first half of 2023.&nbsp;

The trial is designed to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of intramuscular (IM) and intravenous (IV) administration of SPL028, to be paired&nbsp;with psychotherapy in healthy volunteers.

Small Pharma&rsquo;s chief medical and scientific officer Dr. Carol Routledge explained that&nbsp;the first-in-human study of the company&rsquo;s proprietary drug constitutes a milestone in what could potentially become a treatment option with a more extended psychedelic experience as compared to another lead candidate, SPL026&rsquo;s, which is approx. 20 minutes.

Dr. Routledge affirmed that the new SPL028 maintains Small Pharma&rsquo;s goal of providing significantly shorter experiences than that of psilocybin or LSD, which are between six and twelve hours each.&nbsp;

&ldquo;We anticipate that the results of this Phase I study will help us make a data-driven decision in selecting the dose and route of administration to take forward into potential future studies in patients,&rdquo; she concluded.

Small Pharma&rsquo;s CEO added that&nbsp;SPL028 has multi-layered IP protection in several jurisdictions for composition of matter, synthesis and injectable formulations.&nbsp;

&ldquo;The protection currently consists of four <a href="https://www.benzinga.com/general/biotech/22/10/29328100/short-acting-psychedelics-are-running-the-us-patenting-rally-this-company-just-scored">granted patents</a> across the U.S., Canada, the U.K. and Europe and over 30 pending patent applications,&rdquo; he specified.

Indeed, the company&rsquo;s current focus is to explore new therapeutic approaches for depression. Small Pharma&rsquo;s lead candidate&nbsp;<a href="https://www.benzinga.com/markets/cannabis/22/08/28502774/small-pharmas-new-clinical-study-understanding-the-interaction-of-dmt-assisted-therapy-and-ssri-">SPL026</a>, a proprietary synthetic formulation of DMT, is currently advancing a clinical intravenous (IV) program backed with psychotherapy for the treatment of Major Depressive Disorder (MDD), which was granted an Innovation Passport designation by the MHRA.

The novel SPL028 program provides a potential&nbsp;30-minute psychedelic experience which would optimize patient convenience while expanding the therapeutic aid in cases of depressive disorders and other indications as well. 
Photo by <a href="https://unsplash.com/@talhahassan116?utm_source=unsplash&amp;utm_medium=referral&amp;utm_content=creditCopyText">Talha Hassan</a> on <a href="https://unsplash.com/s/photos/lab?utm_source=unsplash&amp;utm_medium=referral&amp;utm_content=creditCopyText">Unsplash</a>

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This Novel Short-Acting Psychedelic Compound Is Ready For First Phase 1 Clinical Try-Out 

Lara Goldstein

<a href="https://www.benzinga.com/markets/cannabis/22/10/29294614/small-pharmas-q2-2023-financial-results-ultra-short-acting-psychedelic-program-underway">Small Pharma Inc</a>.

Dr. Carol Routledge

George Tziras

MHRA

Short-Acting Psychedelics

DMTTF

This Novel Short-Acting Psychedelic Compound Is Ready For First Phase 1 Clinical Try-Out

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