NTC Submits Marketing Authorization Application for KLEERKOL® in the European Union

MilanApril 19, 2022PR Newswire -- NTC Srl, an R&D-driven pharmaceutical company headquartered in Italy, announced the submission of a marketing authorization application via the European Decentralised Procedure (DCP) for its developmental product NTC015 (Kleerkol).^®), which is used for bowel preparation before colonoscopy.

Maurizio Vecchi from the Gastroenterology and Endoscopy Unit of the IRCCS Foundation at Ca' Granda Ospedale Maggiore Policlinico in Milan, Italy, stated："Colonoscopy remains the standard practice for the diagnosis and monitoring of colorectal cancer as well as the diagnosis and monitoring of inflammatory bowel disease.Before the examination procedure, all fecal matter must be completely evacuated from the colon. Currently, all patients are required to undergo bowel preparation as instructed, which sometimes lasts more than a day and includes dietary restrictions, intake of large amounts of fluids and solutions for colon cleansing. An effective medication that allows for rapid bowel cleansing, is palatable, and easy for patients to take represents a new and highly attractive treatment option.

"The bowel preparation surgery before colonoscopy is usually an unbearable experience, but if the preparation is insufficient, it will lead to a discounted effect and more situations requiring repeated examination procedures. In fact, some patients decide not to undergo this examination because of the uncomfortable bowel preparation."Germany LutherVichy PortHouse of HealthStomachGastroenterology and Internal Medicine SpecialistsPeter UebelRepresentation."Therefore, it is very important to provide patients with effective, easy-to-use, fast-acting, simpler, and more palatable bowel preparation medications."

The development of NTC015 aims to meet the demand for fast-acting, easy-to-take, and good-tasting medications. To gain approval, a controlled trial with an adaptive study design was conducted. "We recently completed the 'Satisfaction Trial,' which was a study on Kleerkol."^®large-scale, multi-center international study. Based on the study results, we have submitted a marketing authorization application in the European Union. Our goal is to bring Kleerkol to market as soon as possible.^®Launched in Europe. We also hope to work with our partners to complete registration globally outside of Europe. Currently, we have several countries where collaboration is still possible, in order to provide this innovative solution to patients and doctors."NTCChiefExecutiveRiccardo CarbucicchioConcluded.