SAN DIEGO, CA (July 26, 2022) Hillhurst Biopharmaceuticals, Inc. (“Hillhurst”), a clinical-stage biopharmaceutical company focused on developing liquid drug products containing therapeutic gases, today announced the dosing of the first subject in the Single Ascending Dose (SAD) portion of their Phase 1 clinical trial of HBI-002, an oral low dose carbon monoxide (CO) therapeutic. HBI-002 is targeted for the treatment of sickle cell disease (SCD).  In preclinical efficacy studies, HBI-002 demonstrates potent prevention of vascular stasis in sickle cell disease models.

“Vaso-occlusive pain crises remain a substantial problem for sickle cell disease patients, and HBI-002 has the potential to significantly improve the treatment of this disease.  In the face of a dearth of highly effective treatments, we believe HBI-002 could represent a fundamental and critically needed innovation,” said Andrew Gomperts, Chief Executive Officer of Hillhurst. “We have been eager to start the Phase 1 trial and hope that the promising preclinical profile of HBI-002 will ultimately translate to human studies.”

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

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

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 its proprietary GLASS^TM platform, which enables novel drug products based on therapeutic gases that, up until now, have been limited by inhaled delivery, including a unique pipeline of novel liquid therapeutic candidates intended to treat patients with sickle cell disease, Parkinson’s disease, and acute pain.

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

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