Hillhurst Biopharmaceuticals Doses First Subject in Phase 2a Clinical Trial of HBI-002, a Novel Therapy for Sickle Cell Disease

SAN DIEGO, July 23, 2025 /PRNewswire/ -- Hillhurst Biopharmaceuticals Inc. ("Hillhurst"), a clinical-stage biopharmaceutical company focused on developing novel oral liquid drug products based on known inhaled therapeutics, today announced that the first subject has been dosed in its Phase 2a clinical trial evaluating HBI-002 for the treatment of sickle cell disease.

"Dosing the first subject marks a significant milestone," said co-founder and Chief Executive Officer Andrew Gomperts. "There remains a substantial unmet medical need in preventing the painful vaso-occlusive crises experienced by sickle cell patients. We are hopeful that our novel drug product can provide meaningful relief for patients and their families. We look forward to advancing with this trial and expect the first readout by the end of 2025."

The Phase 2a clinical trial for HBI-002, an oral low-dose carbon monoxide (CO) therapeutic candidate, is an open-label study designed to assess the safety and tolerability of HBI-002 in patients with sickle cell disease. The trial will also collect 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 2026.

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.

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SOURCE Hillhurst Biopharmaceuticals, Inc.