Bezisterim clinical trial uses hybrid design to promote accessibility
Patients have flexibility to complete visits either at home on in clinic
BioVie’s ongoing SUNRISE-PD clinical trial of bezisterim in early Parkinson’s disease uses a hybrid, decentralized approach to center patient experience and promote accessibility, according to the company.
Parkinson’s disease patients often face barriers to accessing specialized care and participating in clinical trials due to delayed diagnosis, limited mobility, and geographic constraints. This trial allows participants to complete visits either at home or in a clinic, improving access and flexibility.
“SUNRISE-PD represents the future of clinical trial design, one that meets people where they are and makes participation possible without compromising scientific rigor,” Cuong Do, president and CEO of BioVie, said in a company press release.
Scientists involved in the study presented a poster highlighting these design choices at the Advanced Therapeutics in Movement & Related Disorders Congress, which recently took place in Maryland.
The Phase 2 trial (NCT06757010) is now recruiting at sites in Michigan, North Carolina, and Ohio. Additional sites in Connecticut and Illinois have not yet started enrolling participants. Individuals ages 45 to 80 who received a Parkinson’s diagnosis within the past 18 months and have not yet started treatment with levodopa or another similar medicine may be eligible.
Bezisterim being tested as a standalone therapy
Scientists believe inflammation in the brain contributes to nerve damage in Parkinson’s disease. As the disease progresses, neurons that produce the chemical signaling molecule dopamine degenerate. This causes a variety of motor and nonmotor symptoms.
For many people with the disease, neurodegeneration is accompanied by brain insulin resistance, in which cells can’t as effectively use blood sugar to produce energy. This process appears to contribute to neurological problems in Parkinson’s.
Bezisterim, a small molecule taken orally, is designed to ease inflammation and insulin resistance in the brain. BioVie acquired the rights from the medication’s original developer, NeurMedix, in 2021.
In an earlier Phase 1/2 clinical trial (NCT05083260), the company tested bezisterim in people with Parkinson’s who were already taking standard medications like levodopa. The main goal was to measure changes in symptoms using a common Parkinson’s rating scale. After about a month, those taking bezisterim showed more improvement than those on placebo, especially in participants younger than 70.
By combining an innovative therapeutic approach with a decentralized model, we are exploring the potential of bezisterim to impact the course of Parkinson’s disease and set a precedent for how studies can be more inclusive, accessible and patient-focused.
With SUNRISE-PD, BioVie plans to examine the therapy as a standalone treatment in people without a prior history of levodopa or similar therapies. The main goal of the study is to measure bezisterim’s effect in lessening motor symptoms, as assessed by the Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) part 3.
The company designed the study to center participants’ experiences. Study nurses will complete in-home visits, with neurologists overseeing appointments via video call. Through this hybrid system, the team will be able to complete the MDS-UPDRS motor exam and assess disease progress. The researchers will also use digital data collection and documentation tools designed to be easy for participants to use. The U.S. Food and Drug Administration (FDA) agreed on the study’s design.
“By combining an innovative therapeutic approach with a decentralized model, we are exploring the potential of bezisterim to impact the course of Parkinson’s disease and set a precedent for how studies can be more inclusive, accessible, and patient-focused,” Do said.
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