BioVie announced on Aug. 6 that its SUNRISE-PD Phase 2 study met success based on a combined analysis of observed improvements in both motor and non-motor symptoms for patients with early-stage Parkinson’s disease. However, the company did not present results for the primary outcome, which measured motor function.
Executives repeatedly described the findings as “exploratory” in prepared remarks and said these results would inform the design of a future Phase 3 trial. BioVie CEO Cuong Do said in a prepared statement, “These exploratory results suggest that bezisterim may have the potential to become the first drug candidate to improve clinical outcomes in Parkinson’s disease beyond motor symptoms.”
Following this update, BioVie’s stock price dropped nearly 50% to around $1 since markets opened Thursday. The study enrolled 57 patients with early-stage Parkinson’s who had not previously received carbidopa/levodopa treatment. The double-blind, placebo-controlled trial tested bezisterim—formerly called NE3107—an oral small molecule intended to cross the blood-brain barrier and act as both an anti-inflammatory and insulin-sensitizing agent.
The primary endpoint listed for SUNRISE-PD was change from baseline over 12 weeks on Part III of the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), which measures motor function. Parts I and II were secondary endpoints focusing on non-motor experiences and daily living activities. BioVie stated, “Patients treated with bezisterim demonstrated statistically significant improvements compared to placebo on both motor and non-motor symptoms, as assessed by MDS-UPDRS Parts I, II and III, as well as a composite endpoint comprising 15 clinically relevant measures.” The company did not share specific statistical data related to MDS-UPDRS III but instead presented a composite endpoint combining several measures into what it called EPNIC-15.
According to BioVie, most patients treated with bezisterim showed improvement on EPNIC-15. The company also reported exploratory biomarker improvements, including statistically significant changes in blood-based inflammatory markers—the main pharmacodynamic assessment submitted in its statistical analysis plan to regulators—and other biological markers linked with cellular health and nerve cell damage.
BioVie reported that bezisterim was well tolerated; adverse events occurred more frequently among those receiving placebo (51.7%) than those taking bezisterim (39.1%). No severe or serious adverse events were recorded, and treatment-related adverse events were noted in both groups.
