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Small Pharma reported top positive results on Wednesday from its first placebo-controlled efficacy study investigating a short-acting psychedelic for the treatment of major depressive disorder (MDD).
SPL026, or intravenous N,N-dimethyltryptamine (DMT), showed statistically significant and clinically meaningful reductions in depressive symptoms compared to placebo two weeks post-dose.
In the phase IIa study, 34 patients with moderate/severe MDD were dosed with 21.5 mg of SPL026. Patients experienced a 20 to 30 minute psychedelic experience followed by supportive therapy by a licensed therapist.
Efficacy was assessed using the Montgomery-Asberg Depression Rating Scale (MADRS), a 10-item diagnostic questionnaire that evaluates the severity of major depressive episodes. Two weeks after the dose, the patients showed a -7.4 change in their MADRS scores compared to those who received placebo.
Durability was also assessed in the clinical trial. Patients who received at least one dose of SPL026 showed sustained improvement in depression symptoms 12 weeks after their dose, with a remission rate of 57%.
The clinical trial consisted of two treatment arms. Patients received either one dose of SPL026 followed by a second dose two weeks later, or a placebo dose followed by one dose two weeks later.
No clear differences were identified in the antidepressant effect between the dosing regimens, the company reported.
“Just one dose of SPL026 with supportive therapy has a rapid onset and long-lasting antidepressant effect,” said Carol Routledge, Ph.D., chief medical and scientific officer, Small Pharma, at a news conference Wednesday.
SPL026 was well tolerated and no drug-related serious adverse events were reported. The most common side effect was pain or a reaction at the infusion site.
The next steps
At the same press conference, George Tziras, CEO, said the company is ready to advance the candidate.
The aim is to “replicate these findings in a larger patient population and answer important additional questions to inform further development of SPL026,” he said, adding that the Phase IIa results provide an international, multi-site ‘ability-to-use’. benefit study possible. .
The short-term psychedelic treatment holds promise for patients who “only experience symptom relief after weeks on existing treatment options,” Tziras said.
Small Pharma is also moving toward other studies with SPL026, including a phase I interaction study with SSRIs and an ongoing phase I study investigating an intramuscular route of administration.
Psychedelic treatments for neuropsychiatric disorders are steadily increasing in the biopharmaceutical sector.
In November 2022, Sensorium Therapeutics raised $30 million in Series A funding to develop psychoactive molecules for neuropsychiatric disorders.
The following month, Compass Pathways announced that COMP360, a synthetic form of psilocybin, showed an 86% remission rate in patients with type II bipolar disorder.