Hillhurst Bio Doses First Subject in Phase 2a Clinical Trial of HBI-002, a Novel Therapy for Parkinson's Disease

SAN DIEGO, June 15, 2026 /PRNewswire/ -- Hillhurst Biopharmaceuticals Inc. ("Hillhurst Bio"), 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 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.

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.

"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, and we are hopeful that our novel drug product can provide benefits to patients.  The first readout is expected by the end of 2026."

This Phase 2a clinical trial for HBI-002 is a blinded, randomized, 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.

About Parkinson's Disease:

Parkinson's disease is a progressive neurodegenerative disorder that affects movement and a range of non-motor functions. While current treatments help manage symptoms, there remains a need for therapies that address the underlying biology of the disease. Parkinson's disease affects approximately 1.1 million people in the United States.

About HBI-002:

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. A Phase 1 clinical study in healthy subjects under an Investigational New Drug (IND) application has been successfully completed. 

About Hillhurst:

Hillhurst Bio 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 and includes a unique pipeline of liquid therapeutic candidates aimed at treating sickle cell disease, Parkinson's disease, and acute pain.

SOURCE Hillhurst Biopharmaceuticals, Inc.