Enrollment complete for phase 2 razuprotafib trial in glaucoma
Aerpio Pharmaceuticals has completed enrollment in its phase 2 razuprotafib trial for patients with elevated IOP associated with open-angle glaucoma or ocular hypertension, according to a press release.
The double-masked, placebo-controlled trial of a topical ocular formulation of razuprotafib will evaluate safety and efficacy in about 195 patients over a 28-day period after a 28-day washout period.
Patients will receive latanoprost ophthalmic solution 0.005% at baseline before being randomly assigned into one of three arms of adjunctive therapy: placebo, 40 mg/mL razuprotafib once daily or 40 mg/mL razuprotafib twice daily. The primary endpoint will be mean diurnal IOP at 28 days in the razuprotafib groups vs. the latanoprost monotherapy group.
“We believe that razuprotafib will represent an attractive adjunctive therapy for glaucoma patients based on its novel mechanism of action and favorable tolerability profile, and we have worldwide rights to the program,” Kevin Peters, MD, chief scientific officer and chief medical officer of Aerpio, said in the release.
Aerpio is aiming to report topline results from the trial in the fourth quarter.