Hillhurst Biopharmaceuticals Receives Phase 2 SBIR Funding For Clinical Development Of HBI-002 For Prevention Of Vaso-Occlusive Crises in Sickle Cell Disease.

SAN DIEGO, CA (Nov. 28, 2018) Hillhurst Biopharmaceuticals, Inc., a biopharmaceutical company focused on developing oral carbon monoxide (CO) therapies, today announced the award of an approximately $2 million Phase 2 Small Business Innovation Research (SBIR) grant from the National Heart, Lung, and Blood Institute (NHLBI).  This award will fund the company through a Phase 1 clinical study.  Hillhurst’s lead candidate, HBI-002, is an oral CO therapeutic for the prevention of vaso-occlusive crises experienced by sickle cell disease (SCD) patients.  CO at low, therapeutic doses has been found safe and tolerable in nine Phase 1 or 2 clinical studies.  Moreover, CO has been demonstrated to both limit sickling and reduce inflammation.  HBI-002 enables the chronic use of CO in SCD that is not feasible with other formulations, including inhaled CO.  The Company anticipates filing an IND in 2019.  Hillhurst is collaborating 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 enables advancing HBI-002 into the clinic to address a significant unmet need in sickle cell disease,” said Andrew Gomperts, Hillhurst’s Chief Executive Officer.  “We believe our novel approach of targeting dual mechanisms to prevent vaso-occlusive crises, including reducing both sickling and inflammation, holds great promise.”

About Sickle Cell Disease
Sickle cell disease is a genetic disorder that causes severe vaso-occlusive pain crises and is associated with stroke, heart disease, kidney disease as well as premature death.  The sickling of red blood cells and inflammation are interrelated causes of the substantial morbidities and mortality of SCD.  Millions of people globally suffer from SCD, including 100,000 people in the U.S.  The average life expectancy of SCD patients in the US is only 45 years.  At the present time, there are a paucity of FDA approved drugs for SCD and a substantial unmet need.

About HBI-002
Hillhurst’s lead product, HBI-002, is a proprietary investigational drug product designed to deliver CO orally to enable the therapeutic use of CO, which has been shown to mimic the cytoprotective effects of the heme oxygenase metabolic pathway.  HBI-002 is an orally dosed therapeutic enabling acute and chronic use for patients suffering from conditions associated with inflammation and cell death, such as sickle cell disease, kidney transplantation, and acute cerebral injury, among others.

About Hillhurst
Hillhurst is a biopharmaceutical company focused on developing carbon monoxide therapeutics with cytoprotective properties, leveraging the heme oxygenase system.  Building on more than fifty years of research into the heme oxygenase enzyme and CO as a therapeutic, Hillhurst has developed HBI-002 to enable the oral delivery of CO to treat conditions associated with inflammation, cell death and oxidative tissue injury.

To learn more about Hillhurst, please visit www.hillhurstbio.com.

Media Contact:   Andrew Gomperts   President and CEO   hillhurstpress@hillhurstbio.com