SBIR Phase I: A Novel Extended Delivery Dual-action Platform for Peptide-based Anti-fibrotics

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This Small Business Innovation Research (SBIR) Phase I project seeks to develop a new drug-delivery microscaffold that can help millions of patients suffering from chronic kidney, liver or lung disease. These diseases are characterized by chronic inflammation of the organ, stiffening or hardening of the organ and a gradual decline in organ function. The proposed microscaffold brings together on one single platform two drugs with very different actions. One drug is aspirin that reduces inflammation and the other drug is Relaxin which can soften hardened tissue and preserve tissue function. Unfortunately, Relaxin cannot be taken orally and is therefore not being used for these indications. This microscaffold, to be implanted under the skin, is designed to release these drugs continuously over several days or weeks. This Phase I program seeks to demonstrate the feasibility of such a concept in cell-based studies by demonstrating that this microscaffold releases both aspirin and Relaxin and that these two drugs retain their activities.The broader impact/commercial potential of this project is significant. These chronic diseases are currently without cure. In fact, chronic kidney disease, cirrhosis and idiopathic pulmonary fibrosis all necessitate organ transplant. In addition to their attendant morbidity and mortality, these diseases cost this country billions of dollars in health care expenses and lost wages. The potential healthcare impact of this highly innovative technology is exceptionally broad. Sustained-release microscaffolds will enable less frequent dosing and translate to better patient compliance. In fact, similar to antibody-based therapies, this extended-release scaffold might necessitate administration only once monthly or even less frequently. By encapsulating a variety of highly potent drugs from insulin to growth factors, custom platforms can be designed to treat a host of indications such as diabetes, keloid scars and tissue fibrosis.