SAN DIEGO, CA (May 23, 2023) Hillhurst Biopharmaceuticals, Inc. (“Hillhurst”), a clinical-stage biopharmaceutical company focused on developing liquid drug products containing therapeutic gases, today announced that the last participant has completed the study protocol of its U.S. Phase 1 clinical trial of HBI-002, an oral low dose carbon monoxide (CO) therapeutic candidate. HBI-002 is targeted for the treatment of sickle cell disease (SCD).

The primary objective of this U.S. single-center, open label Phase 1 study was to investigate the safety, tolerability, and pharmacokinetics of HBI-002 in healthy adult subjects. The study, which included both single ascending dose and multiple dose cohorts, was intended to assess the safety profile of HBI-002, as well as facilitate further development of HBI-002 in subjects with SCD, among other indications. Hillhurst anticipates top line results from the completed trial in Q2 2023.

“With the treatment and follow-up of our final study subject complete, we look forward to reviewing the data and advancing development plans for HBI-002 as an innovative treatment candidate for sickle cell disease,” said Edward Gomperts, Co-founder, Chairman and acting Chief Medical Officer of Hillhurst.  “Vaso-occlusive pain crises remain a substantial problem for people with sickle cell disease.  We are anxious to progress to later stage clinical trials to assess the potential of HBI-002 to improve the treatment of SCD.

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