Hillhurst Biopharmaceuticals, Inc., a biopharmaceutical company, announced the award of a phase 1 Small Business Innovation Research (SBIR) grant from the National Heart, Lung and Blood Institute (NHLBI) of approximately $300,000 to fund further pre-clinical development of Hillhurst's lead candidate, HBI-002, an oral product for the prevention of vaso-occlusive crises experienced by sickle cell disease patients. The heme oxygenase pathway is thought to limit inflammatory processes and prevent apoptosis (cell death). Moreover, other formulations of the drug substance of HBI-002 have been demonstrated to limit sickling in sickle cell disease patients. The company anticipates entering IND-enabling studies within the next year. Hillhurst is collaborating on this project with John Belcher, Ph.D., University of Minnesota Associate Professor of Medicine, and Gregory Vercellotti, M.D., University of Minnesota Professor of Medicine.
"With this award, the NHLBI recognizes the therapeutic potential of HBI-002 to address a significant unmet medical need in sickle cell disease," said Andrew Gomperts, Hillhurst's chief executive officer. "Hillhurst is grateful to the NHLBI for recognizing the value of advancing the development of HBI-002. We believe our novel approach of targeting multiple mechanisms to prevent vaso-occlusive crises, including reducing inflammation, apoptosis, and sickling, holds great promise, which we believe is validated by this award."
Sickle cell disease (SCD) is a genetic disorder that causes severe pain crises and is associated with stroke, heart attack, pulmonary hypertension, kidney disease as well as premature death. The sickling of red blood cells, inflammation and apoptosis are understood to be interrelated causes of the substantial morbidities and mortality of SCD. Millions of people around the world suffer from this disease, including 90,000 people in the US. The average life expectancy of SCD patients in the US is only 42 years. At the present time, there is a dearth of FDA approved drugs for SCD patients.
Hillhurst's lead product, HBI-002, is a proprietary investigational drug product designed to augment the protective cellular heme oxygenase metabolic pathway to limit inflammatory processes, prevent apoptosis (cell death), and, in sickle cell disease patients, to limit sickling. HBI-002 is an orally dosed therapeutic enabling acute and chronic use for patients suffering from conditions associated with inflammation and apoptosis, such as sickle cell disease, kidney transplantation, and acute cerebral injury, among others.