Hillhurst Bio Doses First Patient in Phase 2a Trial of HBI-002 for Parkinson’s Disease

Hillhurst Biopharmaceuticals has announced an important milestone in its Parkinson’s disease program. The company has successfully dosed the first participant in its Phase 2a clinical trial evaluating HBI-002, an investigational therapy being developed for people living with Parkinson’s disease.

The study is supported by funding from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) through its Therapeutics Pipeline Program, along with support from the Farmer Family Foundation.

Phase 2a Trial Begins for HBI-002

The Phase 2a study is a randomized, blinded, controlled clinical trial designed to evaluate the safety and tolerability of HBI-002 in patients with Parkinson’s disease.

In addition to safety assessments, researchers will collect pharmacokinetic and biomarker data to better understand how the therapy behaves in the body and whether it shows signs of potential clinical benefit.

The findings from this study are expected to help shape the design of a larger Phase 2b trial, which Hillhurst Bio plans to initiate in 2027.

According to the company, initial study results are expected by the end of 2026.

Why Researchers Are Exploring HBI-002

The scientific rationale behind HBI-002 comes from decades of epidemiological research showing that cigarette smokers appear to have up to a 60% lower relative risk of developing Parkinson’s disease compared with non-smokers.

Researchers have also observed neuroprotective effects in preclinical studies involving HBI-002.

Hillhurst Bio emphasized that this research is focused on understanding specific biological mechanisms and does not change the well-established health risks associated with smoking.

Company Highlights Need for New Parkinson’s Treatments

Commenting on the trial launch, Andrew Gomperts, Chief Executive Officer of Hillhurst Bio, said the dosing of the first participant represents a major step forward for the program.

He noted that there remains a significant unmet need for therapies capable of addressing the underlying biology of Parkinson’s disease rather than only managing symptoms. The company believes HBI-002 could potentially offer a new treatment approach for patients living with the condition.

About HBI-002

HBI-002 is Hillhurst Bio’s lead investigational drug candidate. It is an oral, low-dose carbon monoxide (CO) therapy designed for long-term use in a home setting.

The product is being developed as a liquid formulation and has already completed a Phase 1 clinical trial in healthy volunteers under an Investigational New Drug (IND) application.

Beyond Parkinson’s disease, the company is also exploring the potential use of HBI-002 in conditions linked to inflammation and cell death, including sickle cell disease.

Understanding Parkinson’s Disease

Parkinson’s disease is a progressive neurological disorder that affects movement, balance, and several non-motor functions.

While currently available treatments can help manage symptoms, they do not stop or reverse disease progression. This has created an ongoing need for therapies that target the biological mechanisms driving the condition.

According to available estimates, approximately 1.1 million people in the United States are living with Parkinson’s disease.

Data Collection to Support Future Development

During the Phase 2a study, researchers will evaluate multiple clinical and biological measures to better understand the impact of HBI-002.

The information gathered will help determine the next steps for development and provide guidance for the larger Phase 2b study planned for 2027.

The company expects the trial to generate important insights into the safety profile of HBI-002 and its potential role as a disease-focused treatment option for Parkinson’s disease.

About Hillhurst Biopharmaceuticals

Hillhurst Bio is a clinical-stage biopharmaceutical company focused on developing innovative liquid drug products through its proprietary GLASS™ platform.

The platform is designed to transform known inhaled therapeutics into oral liquid formulations, helping overcome some of the limitations associated with traditional inhaled delivery methods.

The company’s development pipeline includes programs targeting Parkinson’s disease, sickle cell disease, and acute pain, with a focus on creating more accessible treatment options for patients.

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