Chengdu-based Easton Pharmaceutical Co., Ltd (SHA: 688513) has announced preliminary statistical analysis results from the Phase Ib study of its in-house developed Category 1 biologic drug EP-9001A for bone metastasis cancer pain. The results highlight the drug’s safety and efficacy, supporting its potential as a novel treatment option.
Safety and Pharmacokinetic Profile
EP-9001A demonstrated a favorable safety profile across low (10mg), medium (20mg), and high (25mg) dose groups, with no dose-limiting toxicity (DLT) or serious adverse reactions observed. Pharmacokinetic data showed increased in vivo drug exposure and significantly prolonged half-life with higher doses, supporting long-term dosing exploration in future studies.
Efficacy Results
Preliminary efficacy data indicated significant and sustained analgesic effects in patients with moderate to severe bone metastasis cancer pain. From weeks 6 to 8, the medium (20mg) and high (25mg) dose groups showed marked reductions in daily highest and average pain intensity as measured by the numerical rating scale (NRS). The study will continue as planned to further evaluate these promising results.
Mechanism of Action
EP-9001A is a nerve growth factor (NGF) monoclonal antibody (mAb) that selectively targets and inhibits NGF, blocking pain signals before they reach the spinal cord and brain. Unlike traditional painkillers such as opioids and NSAIDs, EP-9001A offers a distinct mechanism of action. Preclinical studies have demonstrated its strong, long-lasting analgesic effects at low effective doses across multiple pain models.-Fineline Info & Tech