The study showed statistically significant and clinically meaningful reductions in depressive symptoms at two weeks in participants treated with SPL026 compared with placebo, the company said.
- The trial was evaluating the efficacy and safety of SPL026 and enrolled 34 participants who had experienced depression for an average of 10.5 years.
- The reductions in depressive symptoms were observed as early as one week following dosing and were sustained at three months, the company said.
- Helus Pharma, however, said that the company is not advancing intravenous SPL026 in its current form.
Shares of Helus Pharma (HELP) rallied 11% on Tuesday after the company announced positive results from its mid-stage clinical trial evaluating its experimental therapy SPL026 in participants with moderate-to-severe major depressive disorder.
The trial was to evaluate the efficacy and safety of SPL026, and enrolled 34 participants who had experienced depression for an average of 10.5 years.
The study showed statistically significant and clinically meaningful reductions in depressive symptoms at two weeks in participants treated with SPL026 compared with placebo, the company said.
The reductions in depressive symptoms were observed as early as one week following dosing and were sustained at three months, with effects lasting up to six months in some participants, the company said. Further, no treatment-related serious adverse events were reported.
Executive Take Away
“We have shown that a single dose of SPL026 is safe, effective and durable, with treatment effects comparable to other promising interventional treatments often requiring much longer treatment sessions.” said the study’s lead investigator Dr David Erritzoe.
“Although such early trial results should always be interpreted with some caution, these data show the promise of DMT as a potentially more cost-effective treatment for clinical depression than related serotonergic agonists with longer psychoactive action due to the shorter dosing sessions,” they added
Other Pipeline Names
Helus Pharma said that the company is not advancing intravenous SPL026 in its current form. However, the company will use the insights from the trial to inform its HLP004 development program. HLP004 is an experimental drug being studied in the treatment of generalized anxiety disorder. Data from a mid-stage study of HLP004 is expected in Q1 2026.
The company is also developing experimental drug HLP003 as an adjunctive treatment for major depressive disorder.
How Did Stocktwits Users React?
On Stocktwits, retail sentiment around HELP stock stayed within the ‘extremely bullish’ territory while message volume stayed at ‘high’ levels.
“Time to buy more,” a Stocktwits user wrote while raising optimism for the GAD study data raising prices.
Another user, however, expects the stock to pare the gains made on Tuesday through the week.
HELP stock has dropped 27% over the past 12 months.
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