Biovie seeks FDA meeting to plan Phase 3 trial for Parkinson’s drug candidate

Bezisterim, an experimental oral small molecule that Biovie is developing for people with early-stage Parkinson’s disease, is moving toward Phase 3 clinical testing, with the company requesting a meeting with U.S. regulators.

The main goal of the end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) is to discuss the Phase 3 trial design, including which measures of Parkinson’s symptoms will be used to assess the therapy’s potential benefits. The company expects the meeting to take place later this fall and anticipates to receive formal written feedback before the end of the year.

The planned Phase 3 trial is expected to enroll about 175 people with early Parkinson’s, following exploratory findings from the Phase 2 SUNRISE-PD trial (NCT06757010), which showed that the treatment was well tolerated and associated with improvements in measures of motor and nonmotor symptoms.

“We are working closely with leading experts in Parkinson’s disease clinical development to finalize a Phase 3 trial design that includes MDS-UPDRS Part III as the primary endpoint,” Joseph Palumbo, MD, Biovie’s executive vice president of research and development and chief medical officer, said in a company press release.

The Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III is a composite measure that assesses motor symptoms, including tremor, rigidity, and movement problems. Biovie also expects MDS-UPDRS Part I, which evaluates nonmotor symptoms, to play an important role in the Phase 3 program.

Recommended Reading

Sept. 1, 2026 News by Andrea Lobo

Approved Parkinson’s treatment wins OK in EU, to be sold as Hopledo

Bezisterim targets inflammation, insulin sensitivity

Neuroinflammation, or inflammation in the brain, is thought to contribute to the progressive dysfunction and loss of dopamine-producing neurons, the nerve cells affected in Parkinson’s. As dopamine signaling is gradually lost, people can develop motor symptoms such as tremor and slowed movement, as well as nonmotor symptoms ranging from cognitive to mental health problems.

Brain insulin resistance, when brain cells become less responsive to insulin and may have difficulty using blood sugar for energy, has also been reported in Parkinson’s disease. Impaired insulin signaling has been suggested to contribute to neurological changes in Parkinson’s.

Bezisterim (NE3107) is an investigational oral small molecule designed to enter the brain and reduce inflammation and improve insulin sensitivity.

By targeting both the motor and non-motor dimensions of Parkinson’s disease, we believe bezisterim has the potential to become the first therapy to provide meaningful benefits across the full spectrum of Parkinson’s symptoms.

The SUNRISE-PD study tested bezisterim against a placebo in 57 people with early-stage Parkinson’s who had not previously received levodopa, the standard therapy for the disease, for about three months.

Topline results demonstrated that treatment was associated with changes in blood-based markers of inflammation and nerve cell damage. Biovie also reported that bezisterim outperformed the placebo across MDS-UPDRS measures.

Patients receiving bezisterim also experienced a significant reduction in the EPNIC-15 composite endpoint, a scale that combines clinically relevant items from the MDS-UPDRS with a standard measure of sleep quality. The company has said the Phase 2 findings were exploratory and will need to be confirmed in a larger, longer study.

“By targeting both the motor and non-motor dimensions of Parkinson’s disease, we believe bezisterim has the potential to become the first therapy to provide meaningful benefits across the full spectrum of Parkinson’s symptoms,” Palumbo said. “Based on the strength of our Phase 2 results, we believe we have a compelling foundation for a successful Phase 3 program.“