Patient visits wrap up in Parkinson’s trial of oral bezisterim therapy

Topline results from a Phase 2 trial testing oral bezisterim as a first-line, stand-alone treatment for early Parkinson’s disease are expected later this year following the completion of the study’s final patient visit. The developer of the therapy, Biovie, announced that researchers will now begin analyzing data from the trial.

The trial, called SUNRISE-PD (NCT06757010), is evaluating bezisterim’s safety and effectiveness against a placebo in people with newly diagnosed Parkinson’s who have not yet taken carbidopa/levodopa, a standard symptom-management therapy. Bezisterim is designed to target brain inflammation and insulin resistance, two key processes implicated in the disease.

“With this last patient’s treatment visit completed, our team will start the study closeout process, and the Company plans [to] announce topline results in [the third quarter],” Cuong Do, Biovie’s president and CEO, said in a press release.

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Inflammation elevated in brains of newly diagnosed patients

Targeting inflammation and insulin resistance in Parkinson’s

In Parkinson’s, brain inflammation is thought to play a key role in the damage and loss of nerve cells that produce dopamine, a signaling molecule essential for controlling movement. Motor symptoms such as tremor, stiffness, and slowed movement are hallmarks of the disease, but patients may also experience nonmotor symptoms, including sleep problems, anxiety, fatigue, and cognitive changes.

In addition to neurodegeneration, growing evidence suggests brain insulin resistance — a condition in which brain cells can’t effectively use blood sugar to produce energy — may also contribute to the neurological symptoms of Parkinson’s.

The role of insulin resistance in Parkinson’s was recently discussed during a Biovie virtual scientific event featuring Suzanne de la Monte, MD, a professor at Brown University whose research has examined metabolic dysfunction in brain diseases.

Bezisterim, formerly known as NE3107, is an oral small molecule designed to enter the brain and reduce inflammation while improving insulin sensitivity. Unlike carbidopa/levodopa, which helps manage symptoms by boosting dopamine levels, bezisterim aims to target biological pathways thought to contribute to Parkinson’s development and progression. Originally developed by Neurmedix, Biovie acquired rights to the therapy in 2021.

In a previous Phase 2a trial (NCT05083260), bezisterim was tested against a placebo in 46 adults with moderate to severe Parkinson’s, ages 30 to 80, who received the therapy twice daily alongside standard carbidopa/levodopa treatment.

After about one month, bezisterim-treated participants showed greater reductions in motor symptoms than those given a placebo, particularly among patients younger than 70. The therapy also eased nonmotor symptoms, including sleep difficulties and fatigue.

SUNRISE-PD trial design and home visits

SUNRISE-PD was designed to examine the therapy as a stand-alone treatment in people without prior treatment with levodopa or similar therapies. In the trial, up to 60 adults, ages 45 to 80, who received a Parkinson’s diagnosis within the previous 18 months, were randomly assigned to receive either 20 mg of bezisterim or a placebo twice daily for approximately three months.

To promote accessibility, the trial allowed participants to complete visits at home or in a clinic. For those choosing at-home participation, study nurses conducted in-home visits while neurologists oversaw appointments by video call. All data collected were later reviewed and scored by a central rating committee.

The study’s main goal is to assess bezisterim’s ability to lessen motor symptoms, as measured by Part 3 of the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale. Secondary endpoints include bezisterim’s effects on nonmotor symptoms, daily functioning, and overall clinical improvement.

According to Biovie, findings from SUNRISE-PD are expected to help shape the design of a future Phase 3 registrational trial, which is a late-stage study intended to generate the evidence needed to seek regulatory approval if the therapy proves safe and effective.

“This trial was designed to assess bezisterim’s magnitude of therapeutic impact on a series of motor and non-motor endpoints so that we can finalize the design for the Phase 3 registrational trials,” Do said. “We look forward to unblinding the data later this year to understand the molecule’s true potential.”