The clinical trial is a blinded, randomized, controlled study aimed at evaluating the safety and tolerability of HBI-002. Beyond safety, researchers will gather biomarker and pharmacokinetic data to gauge the drug's potential efficacy. This research is backed by The Michael J. Fox Foundation for Parkinson's Research and the Farmer Family Foundation, with initial results expected by the end of 2026.

CEO Andrew Gomperts noted the trial as a major milestone in addressing the underlying pathology of the condition, which impacts roughly 1.1 million Americans. While HBI-002 draws on the epidemiological link between smoking and reduced Parkinson's risk, the company emphasized that the treatment is distinct from the well-documented health hazards of tobacco use. Data from this phase will guide the design of a larger Phase 2b trial scheduled for 2027.