Idera Pharmaceuticals Inc (NASDAQ: IDRA) shared positive interim results from its investigator-sponsored Phase 2 trial, INTRIM 1, involving tilsotolimod, Idera's synthetic Toll-like receptor 9 agonist.
Based on these results, the trial has been stopped early.
The trial included patients with localized, excised melanoma (pathological tumor stage 3-4) with no regional metastases detected and no evidence of distant metastasis.
Noting that there were more patients with ulcerated lesions in the placebo arm than in the tilsotolimod arm, topline interim results showed a 70% lower SLN+ rate among patients injected with tilsotolimod as compared to those injected with placebo.
The placebo SLN+ rate was in the mid-40%s.
Statistical significance exceeded the pre-specified p-value of 0.008.
Adverse reactions included injection site reactions, malaise, fever, and flu-like symptoms.
This interim result validates previously reported results from INTRIM 1 that showed immune activation.
The trial will continue to relapse-free survival (RFS) and overall survival (OS) at 5 and 10 years after SLN biopsy.
Price Action: IDRA shares are up 24.50% at $0.44 on the last check Tuesday.
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