Stayble did not reach the primary endpoint in phase IIb
Stayble Therapeutics recently announced that the company’s phase IIb study did not meet the primary endpoint. The drug candidate STA363 did not show a statistically significant reduction in pain compared to placebo after 6 months. The company now plans to continue evaluating top-line data from the study to create a better understanding of the results.
Stayble Therapeutics is a pharmaceutical company focusing on patients with chronic disc-related back pain. The company’s drug candidate, STA363, is based on lactic acid and is injected into the spinal disc.
In 2023, Stayble Therapeutics completed a phase IIb study with STA363 in patients with degenerative disc disease, and initiated a phase Ib study in patients with chronic disc herniation.
Negative top-line data
On November 9, the company reported top-line data from the phase IIb study showing that the study did not meet the primary objective. According to the predetermined statistical criteria, STA363 did not show a better effect in terms of pain reduction compared to placebo after six months. The market reacted negatively to the announcement and traded the stock down by 90 per cent.
No significant difference between active and placebo
However, Stayble Therapeutics announced that all three groups, i.e. both dose groups and placebo, reported a significant reduction in pain after treatment. At the same time, the company believes that a larger study would probably not have helped in showing a statistically significant difference between the groups, and therefore considers the study to be conclusive.
Two doses were compared with placebo
The phase IIb study was designed as a randomized, double-blind, placebo-controlled concept study. The aim was to assess both the efficacy and safety of two different concentrations of STA363, 60 and 120 mg/ml, compared to placebo in patients with degenerative disc disease. A total of 110 patients were enrolled in the study. The primary objective was to measure a statistically significant reduction in pain after six months.
In addition to pain, the safety profile and secondary endpoints regarding function and quality of life were also evaluated. In terms of secondary endpoints, no significant differences were observed between the two dose groups and placebo. However, a reduced water content in the disc was seen in the high-dose group (120 mg/ml), indicating increased connective tissue transformation. In addition, STA363 showed a good safety profile for up to 12 months.
Stayble Therapeutics plans to continue evaluating top-line data from the study to identify the way forward.
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