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

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project will be to transform the upper gastrointestinal bleeding (UGIB) treatment market. UGIB represents 75% of all GI bleeding cases worldwide and it is one of the leading causes of emergency hospital admission for gastrointestinal complications in the US. Currently, there are no products on the market that can be utilized to quickly stop UGIB prior to endoscopic treatment. Intact Therapeutics’ (IT) proprietary thermogel can rapidly stop UGIB due to its faster gelation time, mucoadhesive properties, and ability to deliver clot-promoting drugs topically at the site of bleeding, all without the need for endoscopy. Topical administration of the medications results in lower required doses, improved efficacy, and fewer side effects. Stabilizing the patient without endoscopy reduces the risk of morbidity and mortality, hospitalization time, the need for blood transfusions, and healthcare system costs. The current lack of a pre-endoscopic treatment for the stabilization of UGIB patients will ensure the broad adoption of IT’s thermogel product. Additionally, the range of therapeutics that could be delivered via thermogels is wide: including but not limited to small molecules, peptides, antibodies, and cells. This Small Business Innovation Research (SBIR) Phase II project seeks to develop a thermogel-based drug delivery platform that combines mechanical and clotting-promoting actions to provide a rapid initial blockade in the upper GI tract and stabilize patients before endoscopy. The prehospital management of UGIB is pivotal to safeguard the conditions of patients prior to an effective endoscopic treatment. IT’s proprietary thermogel’s action is based on two synergistic effects: (1) In-situ gelation (liquid at ambient temperature and becomes a gel when heated to body temperature) provides a mechanical barrier against the blood flow. (2) The slow release of loaded drugs enables complete hemostasis of the haemorrhage site. In this project, the R&D efforts will be dedicated to the further development of the lead formulation identified in the Phase I project and to establish its long-term stability and comprehensive release profile, demonstration of the efficacy of the lead formulation via in-vivo study in a large animal model, and investigation of the pharmacokinetics to establish product safety. The successful completion of Phase II activities will bring the development of IT’s thermogel-based product to the clinical trial-ready stage. 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.