YAVNE, Israel--(BUSINESS WIRE)--Peritech Pharma, a specialty anal-rectal pharmaceutical company, today announced positive pivotal trial results for its lead product, PP-110, a novel over-the-counter (OTC) anti-hemorrhoidal product. PP-110 was found to be effective in treating hemorrhoids and superior to conventional treatment. The results were published on-line in Molecular and Cellular Therapies.
The randomized, open label study compared the safety and efficacy of PP-110, a novel treatment for hemorrhoids, with the US golden standard, Preparation-H® Maximum Strength Cream, in the treatment of grade 2–3 hemorrhoids. Over 100 patients participated in the 14 day study that was conducted in 7 sites by a team of physicians headed by Professor Ehud Klein, Director of Surgery Service Line at Maccabi Health Services, Tel-Aviv, Israel. PP-110 (in gel and wipes form) was provided to some patients once daily, while other patients received Preparation-H Extra Strength© (Pfizer) per label (i.e. 3-4 times per day). Patients receiving PP-110 gel reported statistically significant better results in the three most prevalent clinical parameters relating to common symptoms of hemorrhoids, namely pain, bleeding and itching, compared to patients treated with the comparator.
"The pivotal trial results are very encouraging and exceed our expectations," said Prof. Ehud Klein, Director of Surgery Service Line at Maccabi Health Services, Tel-Aviv, Israel. "We found that the unique formulation of PP-110 provides a long lasting effect, and were extremely pleased to see that even once-daily application is sufficient, which offers patients a true improvement over current topical treatment."
The Company also announced the receipt of a U.S. Patent No. 9,072,747 from the United States Patent and Trademark Office (USPTO), which includes claims protecting the use of PP-110’s compositions and methods of treatment for anorectal disorders. The granted patent has a term extending to March 2034.
"Our novel film-based formulation provides a slow-release mechanism, and as a consequence, a prolonged therapeutic window,” said Dr. Eran Eilat, CEO of Peritech Pharma Ltd. “We are very pleased with the pivotal trial results that clearly demonstrate the benefits our product offers hemorrhoid patients. Together with the recently granted US patent, and under the monograph regulatory track, PP-110 is ready to be marketed and is now well positioned to revolutionize the hemorrhoids OTC market, especially in the United States."
PP-110 for the treatment of hemorrhoids is based on known and approved active ingredients (pramoxine 1% and phenylephrine 0.25%), and contains an innovative delivery system based on film forming agents and volatile solvents. When applied, the volatiles evaporate leaving a thin film which ensures long term contact of the active ingredients with the affected tissue, in addition to an occlusive effect which enhances its efficacy. As a result, once daily application is more effective than competing products applied 3-4 times per day, and patients are exposed to a fraction of the amount of active ingredients compared to competing products.
Hemorrhoids are vascular structures around the anal canal. When swollen or inflamed they cause significant discomfort. The most troubling symptoms include pain, bleeding and itching. About 50% of Americans suffer from hemorrhoids at some point during their life. Over 10% of American adults (or 22 million people) have experienced hemorrhoids during the past year. Close to 3% (or 6.7 million people) suffer from it on any given day. This is a very active patient population with 85% of them using treatment, mostly in the form of OTC or prescription drugs. The worldwide market for OTC hemorrhoids products is estimated at $1B annually, nearly $400M of which, is in the US.
About Peritech Pharma
Founded in 2012, Peritech Pharma is a privately held specialty anal-rectal pharmaceutical company, targeting numerous indications with large markets and clear unmet medical needs. The Company's lead product, PP-110, a novel OTC anti-hemorrhoidal gel, is ready for commercialization in the US. Additional products include PP-120 for pruritus ani (anal itching) which has recently successfully completed Phase I testing, and is planned to commence a pivotal study by the end of 2015. For more info www.peritech-p.com.