FDA OKs Phase 2 clinical trial design of bezisterim for Parkinson’s

The FDA has approved the design for BioVie's upcoming Phase 2 SUNRISE-PD trial to test an oral drug called bezisterim as a first-line treatment for newly diagnosed Parkinson’s disease patients. The trial will focus on how well bezisterim improves motor skills in daily activities, a key measure of Parkinson's symptoms. An earlier, smaller trial showed that bezisterim, when used with standard Parkinson's medication, significantly improved motor control, especially in patients under 70. The new trial will test bezisterim alone in about 60 patients over 12 weeks. If the results are positive, patients may be offered a chance to continue in a longer-term safety study. This research could help establish bezisterim as a treatment option for all Parkinson’s patients and lay the groundwork for future studies on its impact on disease progression.