Short-Acting Psychedelics: DMT-Based Drug Therapy Gets Tested In New Clinical Trial

Psychedelics biotech company Small Pharma Inc. DMTTF has dosed the first subject in its first-in-human clinical trial assessing proprietary DMT drug SPL028 paired with supportive therapy.

Conducted at MAC Clinical Research in Manchester (UK), the randomized, blinded, placebo-controlled, dose-escalating Phase 1 study is designed to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of both intravenous (IV) and intramuscular (IM) administration of SPL028 in healthy volunteers.

The comparison between both routes of administration aims to create options for patients and physicians towards helping expand convenience and accessibility, according to Small Pharma CMO Carol Routledge.

“We expect that the results from this Phase 1 study will enable us to make a data-driven decision in selecting the dose and route of administration to take forward into a patient study,” Routledge said.

Small Pharma’s preclinical studies suggest that SPL028 offers a similar safety and pharmacological profile yet different pharmacokinetics as compared to its lead candidate SPL026 (DMT).

With the drug candidate being tested in this trial, the company’s aim is to develop a treatment that includes an extended psychedelic experience — SPL026’s is 20-25 minutes — but still significantly shorter than the experience of other psychedelics like psilocybin or LSD. 

Moreover, through the SPL028 clinical program, Small Pharma is exploring whether an extended duration could offer a treatment tailored for other mental health conditions in addition to depression. 

"This is a significant milestone for Small Pharma, with our second key program now in clinical development," says CEO George Tziras. "The recent announcement of our positive Phase 2a results demonstrates proof-of-concept for SPL026 in treating major depression. These encouraging results also provide support for our portfolio of DMT-based assets, and give us confidence in driving forward both our SPL026 and SPL028 programs."

Photo: Benzinga edit with photo by Anna Shvets on Pexels and Jynto on Wikimedia Commons.