EpicentRx announced the start of dosing in China for the global Phase 3 clinical trial REPLATINUM (NCT05566041) with partner SciClone Pharmaceuticals. The trial in the US and China is designed to compare the efficacy of RRx-001 and a first line platinum doublet versus a platinum doublet in approximately 300 third-line or beyond extensive stage SCLC patients that previously received a platinum doublet and a checkpoint inhibitor. RRx-001, a tumor-activated small molecule that inhibits the NLRP3 inflammasome and repolarizes tumor associated macrophages (TAMs), is used to restore sensitivity to chemotherapy that has already been tried.

The primary endpoints of the study are progression free survival (PFS) and overall survival (OS) in patients with third line and beyond extensive stage SCLC. The goal is to evaluate the efficacy of platinum doublet rechallenge after treatment with RRx-001 in late line extensive stage SCLC, a stubbornly resistant cancer with a nearly 100% mortality rate. To date, RRx-001 has not been associated with any dose limiting toxicities either alone or in combination with chemotherapy.

EpicentRx and SciClone Pharmaceuticals established a licensing agreement for RRx-001 in Greater China in 2020. The Phase 3 trial follows the successful completion of the Phase 2 QUADRUPLE THREAT clinical trial (NCT02489903) of RRx-001 in late line SCLC patients, which achieved its primary endpoint, meeting criteria to begin REPLATINUM.