Cellix Biosciences Inc. (“Cellix Bio”), a development-stage pharmaceutical company, today announced successful completion of a Pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for the development of CLX-103, a novel molecular conjugate of mesalamine for the treatment of mild to moderate ulcerative colitis.
CLX-103 is designed to specifically target the release of mesalamine within the lower gastrointestinal tract. This will potentially allow local exposure to mesalamine, while minimizing systemic exposure to potentially reduce the known side effects of mesalamine. At the Pre-IND meeting, Cellix Bio received guidance for the development of CLX-103 and, accordingly, Cellix Bio plans to submit its IND application by the second quarter of 2019. Mahesh Kandula, Founder, Cellix Bio India, stated, “We are excited by the responses we have received from the FDA for the development of this novel prodrug of mesalamine. We believe it has the potential to improve the therapeutic profile mesalamine for the treatment of ulcerative colitis.” Cellix Bio has engaged Dr. Frank Diana (Chemistry, Manufacturing and Controls) and Dr. Mudher Albassam (Non-clinical) to bolster its pipeline development team. Cellix Bio also has engaged Camargo Pharmaceutical Services, LLC, to lead the regulatory and strategic development of CLX-103 in the United States.