Hillhurst Biopharmaceuticals Receives Study May Proceed Letter From US FDA to Initiate Phase 1 Clinical Trial of HBI-002

SAN DIEGO, CA (April 23, 2021) Hillhurst Biopharmaceuticals, Inc. (“Hillhurst”), a clinical-stage biopharmaceutical company focused on developing oral therapies enabling the therapeutic use of low dose carbon monoxide (CO), today announced that the company has received a Study May Proceed Letter from the U.S. Food and Drug Administration (FDA) permitting the company to begin its Phase 1 trial for HBI-002, an oral CO therapeutic for the treatment of sickle cell disease (SCD). This research is supported by a competitive Phase 2 SBIR grant from the National Heart, Lung, and Blood Institute (NHLBI).

“We are very pleased that Hillhurst’s first IND has been favorably reviewed,” said Edward Gomperts, MD, company co-founder and emeritus professor at the University of Southern California. “This represents a major milestone as our lead product candidate, HBI-002, advances into the clinic. We look forward to embarking on our next chapter as a clinical-stage company, harnessing our platform to evaluate the therapeutic potential of low dose carbon monoxide to prevent vaso-occlusive crises and transform the lives of patients with sickle cell disease.”

The Phase 1 clinical trial is a multi-part study, incorporating both single and multiple dose cohorts to assess the safety, tolerability and pharmacokinetics of HBI-002 in healthy subjects, and is expected to begin in mid-2021.

There is substantial literature, both clinical and preclinical, supporting a potential therapeutic role for low dose CO treatment of SCD that has a unique dual mechanism of action: reduction of inflammation and cell death and blocking the polymerization of hemoglobin.

The content in this release is the sole responsibility of Hillhurst and does not necessarily represent the official views or imply endorsement of the National Institutes of Health.

About Sickle Cell Disease
Sickle cell disease is a genetic disorder that causes severe vaso-occlusive pain crises and is associated with serious clinical consequences including stroke, heart disease, kidney disease as well as premature death. The average life expectancy of SCD patients in the US is only 45 years, reflecting the substantial unmet medical need.

About HBI-002
Hillhurst’s lead product, HBI-002, is an oral drug product candidate of low dose CO, with an administration route designed to enable chronic use in a home setting for patients suffering from sickle cell disease. Other potential disease targets are conditions associated with inflammation and cell death such as Parkinson’s disease.

About Hillhurst
Hillhurst is a clinical stage company focused on hematologic and inflammatory disorders. It has generated compelling preclinical efficacy data with its lead product HBI-002. Hillhurst has developed a novel platform that enables oral delivery of low dose CO, intended to mimic the protection afforded by the cytoprotective heme oxygenase enzyme.

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

CONTACT: Andrew Gomperts   President and CEO   hillhurstpress@hillhurstbio.com