SAN DIEGO, CA (October 28, 2026) Hillhurst Biopharmaceuticals Inc. (“Hillhurst”), a clinical-stage biopharmaceutical company focused on developing novel oral liquid drug products based on known inhaled therapeutics, today announced the completion of its Phase 2a clinical trial evaluating HBI-002 for the treatment of sickle cell disease. Results of this proof-of-concept clinical study will be presented at the 2026 Annual Meeting of the American Society of Hematology in New Orleans.
“Patients living with Sickle Cell Disease need more effective treatment options. These early findings with HBI-002 are encouraging because they suggest not only the protection of red blood cells and a reduction in inflammation and Vaso-Occlusive Crises, but also to the potential protection of organs, such as the kidney, that can be affected over time, as was previously found in preclinical sickle cell models,” said Edward Gomperts, Executive Chairman and Chief Medical Officer. “While further study is required, we believe this work represents an important step toward addressing a significant unmet need.”
The Phase 2a clinical trial for HBI-002, an oral low-dose carbon monoxide (CO) therapeutic candidate, was an open-label study designed to assess the safety and tolerability of HBI-002 in patients with sickle cell disease. The trial also collected efficacy biomarker and pharmacokinetic data, providing preliminary insights into the investigational therapy’s potential efficacy. Data from this study will inform the design of the larger Phase 2b clinical trial, planned to begin in 2027.
About Sickle Cell Disease:
Sickle cell disease (SCD) is a genetic disorder that causes severe vaso-occlusive pain crises and is associated with serious clinical consequences, including stroke, heart disease, kidney disease, and premature death. The average life expectancy of SCD patients in the U.S. is only 45 years, underscoring the urgent need for more effective treatments.
About HBI-002:
HBI-002 is Hillhurst’s lead product candidate, an oral low-dose carbon monoxide (CO) investigational drug designed for chronic use in a home setting by patients with sickle cell disease. Other potential indications for HBI-002 include conditions associated with inflammation and cell death, such as Parkinson’s disease. A Phase 1 clinical study in healthy subjects under an Investigational New Drug (IND) application has been successfully completed.
About Hillhurst:
Hillhurst is a clinical-stage company focused on its proprietary GLASS™ platform, which enables the development of novel drug products based on known inhaled therapeutics. The platform overcomes limitations of traditional inhaled delivery methods.
This research is supported by the NHLBI under grant number 2R44HL131065-05. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
For more information, please contact Onne Ganel at hillhurstpress@hillhurstbio.com