Processa Pharmaceuticals (NASDAQ:PCSA) provided a Phase 2 clinical update for its combination therapy, NGC-Cap (PCS6422 + capecitabine), on December 17, 2025.
The preliminary analysis, based on data from the first 16 of 19 randomized patients, demonstrated that NGC-Cap increases exposure to capecitabine's active, cancer-killing metabolites, while maintaining comparable severity of side effects to the standard capecitabine monotherapy.
In the study, patients were dosed with NGC-Cap at 150 mg twice daily (BID), compared to the standard capecitabine monotherapy at 1,000 mg/m² BID.
Notably, exposure to the catabolite FBAL, a key component of the cancer-killing effect, was reduced by up to 10-fold in the NGC-Cap group.
A formal interim analysis of the first 20 patients is expected in early 2026, with final enrollment in the Phase 2 study targeted for completion by the end of Q1 2026.
The data suggest that NGC-Cap could offer a more effective and manageable option for cancer treatment while reducing the severity of side effects often associated with capecitabine monotherapy.