SAN DIEGO, CA (March 6, 2025) — 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 company has received a Study May Proceed Letter from the U.S. Food and Drug Administration (FDA) permitting the company to begin its Phase 2a clinical trial evaluating its investigational product, HBI-002, for the treatment of people with Parkinson’s disease. This trial is supported by funding from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) as part of MJFF’s Therapeutics Pipeline Program and the Farmer Family Foundation.

“We are very pleased that this IND has been favorably reviewed,” said co-founder and Chief Executive Officer Andrew Gomperts. “There remains a substantial unmet medical need in treating people with Parkinson’s disease, and we are hopeful that our novel drug product can provide meaningful relief to patients. We look forward to advancing with this trial and expect the first readout 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. 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 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