RDD Pharma Completes Enrollment in European Phase 3 Clinical Trial for Chronic Anal Fissure

NEW YORK and TEL AVIV, Israel, Jan. 4, 2018 /PRNewswire/ -- RDD Pharma, a specialty pharmaceutical company focused on the development and commercialization of innovative therapeutics for anorectal diseases and gastrointestinal disorders, announced today they have completed enrollment in the pivotal Phase 3 study in Europe of RDD-1219 for the treatment of chronic anal fissure.

In December 2017, an independent data monitoring committee reported no safety concerns and confirmed the company's statistical assumptions, recommending that no further enrollment was required.

"With only one Phase 3 study required in Europe, we are looking forward to completion of the study this year and filing the MAA in 2019," said Jason Laufer, CEO of RDD Pharma. "RDD-1219 Capositorytm has the potential to provide pain relief and to promote healing of this extremely painful and difficult to treat condition."

Study Design
The randomized, double-blind, placebo-controlled multi-site Phase 3 trial, conducted in Europe, is evaluating the efficacy and safety of two dosing regimens - once daily or twice daily. Patients are treated for 8 weeks with an 8-week follow-up period. The primary endpoint is rectal pain reduction assessed via a visual analogue scale (VAS).

About Chronic Anal Fissure and RDD-1219
Chronic anal fissure is a painful condition caused by a tear in the anal canal that does not heal.  There are an estimated 235,000 new cases of anal fissure reported every year in the US, and about 40% of them persist for months and even years. RDD 1219 is based on the calcium channel blocker, nifedipine, and a novel, anatomically targeted drug-delivery system, the Capositorytm.

About RDD Pharma
RDD Pharma is a privately held specialty pharma company focused on fast-track development and commercialization of innovative therapeutics for anorectal diseases and lower-gastrointestinal tract disorders. The company has two clinical stage products and two pre-clinical products, all which serve significant unmet needs. RDD-1219 for chronic anal fissure has completed enrollment in a European Phase 3. RDD-0315 for fecal incontinence, an indication for which there is no approved Rx product, has completed a Phase 2a study in Europe. The European Medicines Agency has granted RDD-0315 Orphan Drug status in spinal cord injury patients. An IND will be filed in the US in Q2-2018. Two pre-clinical assets are also in development for pruritus ani and radiation colitis/proctitis. 

SOURCE RDD Pharma