Hillhurst Biopharmaceuticals Inc, a clinical-stage biopharmaceutical company focused on developing novel oral liquid drug products based on known inhaled therapeutics, announced on Monday that the first subject has been dosed in its Phase 2a clinical trial evaluating HBI-002 for the treatment of Parkinson's disease.

This trial is supported by funding from The Michael J. Fox Foundation for Parkinson's Research (MJFF), as part of its Therapeutics Pipeline Program, and the Farmer Family Foundation.

Hillhurst Bio said that the therapeutic rationale for HBI-002 stems from long-standing epidemiological evidence indicating up to a 60% lower relative risk of developing Parkinson's disease among cigarette smokers and is supported by preclinical data showing neuroprotection with HBI-002. This research is distinct from and does not mitigate the well-established health risks associated with smoking.

The Phase 2a trial for HBI-002 is a blinded, randomised, controlled study designed to assess the safety and tolerability of HBI-002 in people with Parkinson's disease. Biomarker and pharmacokinetic data will also be collected to provide 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.

HBI-002 is Hillhurst Bio's lead investigational product candidate, an oral low-dose carbon monoxide (CO) drug designed for chronic use in a home setting by patients with Parkinson's disease. In addition to Parkinson's disease, other potential indications for HBI-002 include conditions associated with inflammation and cell death, such as sickle cell disease.