SBIR Phase II: Biomaterials and Chemistry to Enhance the Delivery of Medicines in the Body

This Small Business Innovation Research (SBIR) Phase II project supports the development of a technology to improve the way drugs are delivered in the body. Less than 2% of the dose of any medication finds its way to the place in the body where it is needed. The other 98% is either eliminated or, even worse, concentrates in areas where they can lead to side effects. This happens with all medications from daily anti-inflammatory drugs to the latest cancer therapies. If successful, this new approach will turn a regular drug into a medicine that is concentrated and activated only at the area where it is needed. This advance should increase the efficacy of the therapy and minimize its side effects. For example, the local drug activation can target chemotherapies to tumors with minimal side effects. Antibiotics could be delivered at higher local doses than is currently possible, eliminating local infections and limiting the creation of drug-resistant bacteria. Anti-inflammatory medications could be more powerful, improving the management of post-operative pain, potentially reducing the use and misuse of opioid drugs. Overall, this technology could reduce the costly burden of adverse drug events, estimated at more than $177 billion. To create targeted medicines, researchers rely on the endogenous differences between diseased tissue and the rest of the body (e.g., molecular markers or differences in enzymatic activity). Local drug activation provides a new path to create targeted medicines. The approach starts by injecting a biodegradable polymer at the desired site. The material contains exogenous chemical activators that do not exist anywhere else in the body. Then a drug is given systemically that is inactive until it comes in contact with the gel improving local efficacy and diminishing systemic side effects. Phase 1 results showed that an inactivated chemotherapy eliminated tumors in mice after only 10 days of therapy with minimal side effects. The Phase II project will expand the benefits of the local drug activation platform to other therapies, including cancer therapies and pain medications. The long-term goal is to show the applicability of the approach to multiple classes of drugs and increase their potential to improve outcomes for diseases that affect local areas of the body. If successful, this advance should enable medications for people who are too frail to receive them and enable therapies to work in combinations that were previously impossible due to dose-limiting toxicities.