SBIR Phase I: A thermogel-based drug delivery platform for the upper gastrointestinal bleeding treatment

Intact Therapeutics, Palo Alto CA

Investigators

Abstract

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to develop an innovative method to treat upper gastrointestinal bleeding (UGIB). UGIB results in more than 550,000 hospitalizations per year in the US alone with a mortality rate of up to 20%. The gastrointestinal (GI) bleeding market is projected to be nearly USD 1 billion by 2026, with the overall hemostatic agents market reaching over USD 5 billion. Current solutions require endoscopy performed by a specialist or hospital admission. The proposed approach is a drinkable formulation to stop bleeding after ingestion, eliminating the need for endoscopic intervention or hospitalization. The technology developed in this project could then be applied to other bleeding scenarios, including field/combat medicine or rapid treatment of hemorrhage during surgical complications. The gel can also be used as a drug delivery vehicle for a variety of disorders of the upper GI tract. This Small Business Innovation Research (SBIR) Phase I project will demonstrate a new approach to achieve hemostasis in patients with upper gastrointestinal bleeding (UGIB), based on a novel thermosensitive gel (thermogel) formulation. The drinkable formulation is liquid at ambient temperature and becomes a mucoadhesive gel when warmed to body temperature, thereby treating hemorrhage in the upper GI tract without the need for endoscopic intervention. Its action is based on two synergistic effects: (1) The in situ gelation of the mucoadhesive thermogel provides a mechanical barrier against blood flow, and (2) the slow release of drugs from the thermogel at the hemorrhage site enables more rapid healing. Initial efforts will be dedicated to formulation development wherein compatibility of the thermogel with different drug candidates will be evaluated, and optimization of the gelation temperature will be performed. The best formulations will then be tested in vitro for stability, drug release kinetics, and mucoadhesion. Finally, the effectiveness of the proposed approach will be assessed in preclinical models of bleeding, demonstrating its superior ability to reach hemostasis. This is expected to apply to disorders including gastroesophageal reflux disease, eosinophilic esophagitis, and oral mucositis. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.