Hillhurst Bio Doses First Subject in Phase 2a Trial of HBI-002, an Oral Carbon Monoxide-Based Therapy for Parkinson's Disease
核心洞察
Hillhurst Biopharmaceuticals (搜索) has dosed the first subject in its Phase 2a clinical trial of HBI-002 for Parkinson's disease (搜索), with initial data readout expected by the end of 2026.
HBI-002 is an oral low-dose carbon monoxide drug designed for chronic home use, supported by epidemiological evidence showing up to 60% lower relative risk of Parkinson's among smokers.
The blinded, randomized, controlled trial will assess safety and tolerability while collecting biomarker and pharmacokinetic data to inform a larger Phase 2b trial planned for 2027.
Hillhurst Biopharmaceuticals (搜索) Inc., a San Diego-based clinical-stage biopharmaceutical company, announced today that the first subject has been dosed in its Phase 2a clinical trial evaluating HBI-002 for the treatment of Parkinson's disease (搜索). The milestone marks the first clinical assessment of an oral low-dose carbon monoxide (CO) drug in this patient population, with an initial data readout anticipated by the end of 2026.
"Dosing the first subject in this study marks a significant milestone," said Chief Executive Officer Andrew Gomperts. "There remains a substantial unmet medical need for therapies that address the underlying patho-biology of Parkinson's disease (搜索), and we are hopeful that our novel drug product can provide benefits to patients."
The trial is supported by funding from The Michael J. Fox Foundation for Parkinson's Research (MJFF), through its Therapeutics Pipeline Program, and the Farmer Family Foundation.
Therapeutic Rationale and Mechanism
The scientific premise for HBI-002 draws on long-standing epidemiological evidence indicating up to a 60% lower relative risk of developing Parkinson's disease (搜索) among cigarette smokers. This observation is further supported by preclinical data demonstrating neuroprotection with HBI-002. Hillhurst Bio emphasizes that this research is distinct from and does not mitigate the well-established health risks associated with smoking.
HBI-002 is the company's lead investigational product candidate, formulated as an oral liquid designed for chronic use in a home setting. The drug is developed using Hillhurst Bio's proprietary GLASS platform, which enables the creation of novel drug products based on known inhaled therapeutics while overcoming limitations of traditional inhaled delivery methods. Beyond Parkinson's disease (搜索), other potential indications for HBI-002 include conditions associated with inflammation and cell death, such as sickle cell disease (搜索).
Trial Design and Next Steps
The Phase 2a clinical trial is a blinded, randomized, controlled study designed to assess the safety and tolerability of HBI-002 in people with Parkinson's disease (搜索). In addition to safety endpoints, the study will collect biomarker and pharmacokinetic data to provide preliminary insights into the investigational therapy's potential efficacy.
Data generated from this trial will inform the design of a larger Phase 2b clinical trial, which the company plans to initiate in 2027. A Phase 1 clinical study of HBI-002 in healthy subjects under an Investigational New Drug (IND) application has already been successfully completed.
Disease Burden and Unmet Need
Parkinson's disease (搜索) is a progressive neurodegenerative disorder affecting movement and a range of non-motor functions. Approximately 1.1 million people in the United States live with the condition. While current treatments help manage symptoms, there remains a need for therapies that address the underlying biology of the disease.
Hillhurst Bio's pipeline also includes additional liquid therapeutic candidates targeting sickle cell disease (搜索) and acute pain, all built upon the company's GLASS platform technology.