Details

Our investigational product candidate, neridronate, targets complex regional pain syndrome type 1 (CRPS-1), a devastating disease that causes severe, unrelenting and frequently lasting pain following a trauma to the bone or an injury.

Patients may experience significant functional loss, sleep disturbance, and meaningful diminished quality of life and independence.

The FDA has awarded neridronate Breakthrough Therapy, Fast Track, and Orphan Drug designations, reflecting the high unmet need for a CRPS-1 treatment. The Phase 3 pivotal trial (CRPS-RISE) represents a first-in-class approach to addressing a disease with no FDA-approved medicines.

CRPS-RISE is a Phase 3, pivotal study to evaluate neridronate in patients with CPRS-1. Neridronate will be administered intravenously (IV) in a single cycle of 4 infusions during a consecutive 10-day period. The goal is to demonstrate neridronate’s ability to safely reduce pain and other CRPS-1 effects and to improve function and quality of life.

Neridronate is not a simple pain reliever but is believed to get at the root of CRPS-1. As such, CRPS-RISE takes a precision medicine approach, recognizing that not all patients with CRPS-1 are the same. Based on earlier studies and neridronate’s potential effects on bone, inflammation, and neuromodulation, our study focuses on those who are most likely to benefit from neridronate: early CRPS-1 patients in the warm phase and with a positive triple phase bone scan.