Delivery of Nanoencapsulated TGFbeta and ATRA for the Treatment of IBD

Abstract TGF NanoCapis an oral combination of nanoparticulate transforming growth factor betaTGFand alltrans retinoic acidATRAin pre clinical development for treatment of inflammatory bowel diseaseIBDPhase I studies provided proof of principle for efficacy in a murine modelPhase II work optimized therapeutic protocolconfirmed efficacy in a second modelestablished scale up manufacturing methodscompleted rodent toxicology studiesand conducted a type C meeting with the FDA to gain guidance in support of an investigational new drugINDfilingThe present applicationaccording to FDA guidanceproposes additional rodent toxicology and formulation studiessynthesis and qualification of drug product for use in non human primatesexecution of a type B pre IND meeting with the FDA and finallyrequired primate toxicology in support of an open IND applicationWork will be performed in collaboration with Bend ResearchIncComparative Biosciences Incand Regulatory Professionals Incas well as with DrPeter MannonProfessor of MedicineDivision of Gastroenterology andampHepatologyand Director Gastroenterology Hepatology Clinical Research Program at the University of AlabamaSuccessful completion of the Phase IIb studies will facilitate the advancement of TGF NanoCaptowards phase I II clinical trials in patients with Crohn s disease and ulcerative colitis Project Narrative Current therapies for inflammatory bowel diseasesIBDsuch as Crohn s disease and ulcerative colitis fail a considerable percentage of patients due to ineffectiveness or therapy limiting side effectsTherapyXInc is developing a more advanced drug delivery system that targets Transforming Growth Factorand Retinoic Acid to the site of inflammation in the gut thereby reducing systemic side effectsThis therapy has the potential to significantly improve morbidity and quality of life for those suffering with IBD