RDD Pharma doses first patient in phase 3 trial for chronic anal fissure

"Dosing the first patient in our Phase 3 program is an important milestone for RDD Pharma in the development of our lead product candidate," said Jason Laufer, CEO of RDD Pharma.

"RDD 1219 Capository has the potential to provide pain relief and to promote healing of this extremely painful and difficult to treat condition. We are now focused on successfully executing this trial, which is designed to establish a clear path to approval in major global markets."

"Current therapeutic options for anal fissure are limited: they can be challenging for patients to administer and are associated with systemic side effects," continued Mr. Laufer.

"RDD 1219 is based on a calcium channel blocker and a novel, anatomically targeted drug-delivery system that has the potential to provide effective treatment that is easy to administer and without systemic side effects."

The randomized, double-blind, placebo-controlled multi-site Phase 3 trial is being conducted in Europe, and will evaluate the efficacy and safety of two dosing regimens (once daily or twice daily).

RDD plans on enrolling approximately 470 patients in this pivotal EU study.