- 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.
- Related: Idera Shares Fall After Early Tilsotolimod Data, Seeks Collaborating Partners For TLR9 Agonist.
- 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.
Read at Benzinga