The US Food and Drug Administration (FDA) approved the clinical trial design for a Phase 2 study on bezisterim, an oral drug for people newly diagnosed with Parkinson’s disease. BioVie is the company that manufactures the drug candidate, and is undertaking the SUNRISE-PD trial.
The FDA reviewed the company’s study protocol and recommended that researchers evaluate motor skills in daily activities using the Part 2 score of the Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) as a primary goal. The company had initially included it in the trial design as a secondary goal.
“We are currently engaged in trial start up preparations, and hope to initiate patient screening in [the last three months] of 2024,” Cuong Do, BioVie’s president and CEO, said in a company press release.
“Our Phase 2a trial demonstrated that bezisterim in conjunction with levodopa may dramatically [improve] motor control for patients with moderate to severe symptoms of Parkinson’s disease. The Phase 2 SUNRISE-PD trial is designed to explore bezisterim’s impact on symptoms of Parkinson’s disease in patients who need medication for the first time,” Do said.
Bezisterim, previously known as NE3107, is a small oral molecule that promotes anti-inflammatory and insulin-sensitizing responses. Experts think that inflammation in the brain, or neuroinflammation, damages dopamine-producing nerve cells — the disease’s hallmark — and leads to disease progression. Dopamine is a chemical messenger that allows nerve cells to communicate and, among other functions, helps regulate movement. People with Parkinson’s disease display brain insulin resistance, which happens when brain cells can’t respond to the insulin hormone to use blood sugar for energy production.
The drug candidate was originally developed by NeurMedix, and BioVie acquired the rights to it in 2021.
The earlier stage of the upcoming trial included 46 adults with Parkinson’s disease who ranged from 30 to 80 years old. The participants took bezisterim twice a day along with the standard carbidopa/levodopa regimen. After about one month, people taking bezisterim had a greater reduction in motor symptom severity compared with those on a placebo. Results were even more pronounced in participants under 70 years old, the data showed.
In the upcoming trial, about 60 participants will be randomly assigned to take an oral capsule of either 20 mg of bezisterim or a placebo twice daily for 12 weeks.
