On Wednesday, Small Pharma made a major breakthrough in the development of treatment for major depressive disorder (MDD) when they reported positive results from their first placebo-controlled efficacy study of a short-duration psychedelic. This breakthrough provides a promising new option for those struggling with MDD.
A double-blind, placebo-controlled study has revealed that taking a single dose of the psychedelic drug SPL026, or intravenous DMT, had a significant and clinically meaningful impact in reducing symptoms of depression two weeks later. This exciting finding holds promise for further exploration of the therapeutic potential of psychedelics in treating mental health issues.
In a Phase IIa trial, 34 patients with moderate to severe Major Depressive Disorder (MDD) were administered 21.5mg of SPL026, resulting in a 20 to 30-minute psychedelic experience. Following the experience, patients were provided with supportive therapy from a licensed therapist to guide them through their journey.
Two weeks after treatment, patients who received the dose showed a marked improvement in their depression scores on the Montgomery-Asberg Depression Rating scale (MADRS), with an average decrease of 7.4 points in comparison to those who received the placebo. These results demonstrate the efficacy of the treatment in providing relief from depressive symptoms.
SPL026 proved to be a highly effective treatment for depression in a recent clinical trial, with 57% of patients showing durable improvement in symptoms after just one dose. At 12 weeks post-treatment, many patients had achieved complete remission, demonstrating the remarkable efficacy of SPL026.
The clinical trial involved two groups of patients. One group was given SPL026, a powerful medicine, twice in two weeks, while the other group was given a placebo. The effects of these treatments were then compared to determine the efficacy of SPL026.
No clear distinctions in the antidepressant effects of varying doses were found, according to the company’s report. Consequently, the effectiveness of the medication remained the same regardless of the dosage.
Small Pharma’s chief medical and scientific officer, Carol Routledge, Ph.D., revealed a remarkable finding Wednesday: just one dose of SPL026 combined with support therapy can produce rapid, lasting antidepressant effects. This breakthrough promises to revolutionize the treatment of depression.
SPL026 proved to be safe and well-tolerated, with no serious adverse events reported. The most common side effect was pain or irritation at the infusion site. Fortunately, these were mild and generally well-managed.
The Next Steps
At a press conference, George Tziras, CEO of the company, declared that the company is ready to propel their candidate forward and make strides in their journey.
The main goal is to expand on the promising findings of SPL026, with the help of a larger patient population, in order to answer key questions that will pave the way for its further development. With the successful completion of the Phase IIa results, we are now equipped with the data and insight necessary to launch an international, multi-site ability-to-benefit study.
For those who have struggled to find relief from their symptoms with existing treatments, the short-duration psychedelic treatment can offer a glimmer of hope. This promising new treatment has the potential to provide symptom relief in a much shorter timeframe than traditional treatments. According to Tziras, this could be a game-changer for those who have been suffering for weeks on end.
Small Pharma is taking SPL026 to the next level with two exciting studies. A Phase I interaction study is underway to understand how SPL026 interacts with SSRIs, and a Phase I study is exploring an intramuscular route of administration. These studies are an important step towards furthering our understanding of the potential applications of SPL026.
The use of psychedelic treatments to address neuropsychiatric conditions is on the rise in biopharma, offering exciting new possibilities for those seeking relief from mental health issues.
In November 2022, Sensorium Therapeutics made headlines when they secured $30 million in Series A funding for their revolutionary project: the development of psychoactive molecules to help treat neuropsychiatric diseases. This game-changing venture promises to revolutionize the way we look at mental health and make a major impact on the lives of those suffering from such conditions.
In a groundbreaking study, Compass Pathways announced that COMP360, a synthetic form of psilocybin, achieved an astonishing 86% remission rate in patients suffering from type II bipolar disorder. This is a huge leap forward in the treatment of this serious mental illness, with the potential to drastically improve the lives of those affected.