BioSpecifics Technologies Corp. announced top-line data from the Phase 2 dose escalation clinical trial of collagenase clostridium histolyticum (CCH) for the treatment of human lipoma. Lipomas are benign fatty tumors that usually present as painful or palpable lumps in the subcutaneous tissues.

The primary efficacy outcome of active reduction of the visible surface area of the lipoma as measured by caliper was met, combining all patients (p<0.0001). There were no serious adverse events reported during the trial. This Phase 2 open-label single-center dose escalation study assessed the safety and efficacy of CCH in 14 patients with lipoma, divided into four dose cohorts.

Each patient received a single injection of CCH in one of four ascending doses based on the current commercial dose of CCH in marketed indications, ranging from 0.058 mg (10% of commercial dose) to 0.44 mg (75% of commercial dose). The primary efficacy outcome was reduction in lipoma visible surface area as measured by caliper. Data showed patients in the high dose group (75% of commercial dose) achieved the best efficacy results with an average of 67% reduction of lipoma visible surface area as measured by caliper at six months post-treatment.

Additionally, data demonstrated that 75% of patients in the high dose group achieved reduction of 50% or more in lipoma visible surface area.