New drug eases Parkinson’s symptoms, cuts inflammation

People with early Parkinson’s disease who received the oral therapy bezisterim in a Phase 2 clinical trial saw significant improvements in a measure of symptom severity compared with patients given a placebo, top-line results showed.

Trial results also showed that bezisterim was generally tolerated well and that the therapy reduced markers of inflammation and brain damage, according to bezisterim’s developer, Biovie. The findings “provide a framework for patient selection for a future Phase 3 trial design,” the company said.

“We are encouraged by the clinical, biomarker … and safety findings observed in this focused study of 57 patients over 12 weeks of treatment and look forward to presenting these results at an upcoming medical meeting,” Joseph M. Palumbo, MD, chief medical officer at Biovie, said in a company press release. “These exploratory findings strengthen our confidence in bezisterim’s potential to address the broad symptomatic burden of Parkinson’s disease and will inform the design of a future potentially registration study.”

Parkinson’s disease is a neurological disorder marked by the death of brain cells responsible for making the chemical messenger dopamine. Lack of dopamine signaling can lead to motor symptoms like slowness and tremor, as well as nonmotor symptoms ranging from memory problems to mental health issues. Standard therapy involves levodopa, which works to give the brain more raw materials with which to make dopamine. This can help ease Parkinson’s symptoms, but it doesn’t alter the disease’s progression.

The causes of Parkinson’s aren’t fully understood, but abnormal inflammation in the brain is thought to play a key role in driving disease progression. Bezisterim is designed to treat the disease by dampening brain inflammation. The experimental therapy may also improve sensitivity to the hormone insulin; reduced sensitivity to this hormone has also been implicated in Parkinson’s.

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Trial meets objectives on inflammatory markers, symptoms

Biovie sponsored the proof-of-concept trial, called SUNRISE-PD (NCT06757010), which tested bezisterim against a placebo in 57 people with early-stage Parkinson’s who had never taken levodopa. Participants were given the experimental therapy or a placebo for about three months.

The study’s main goal was to assess how bezisterim altered certain blood-based inflammatory markers. The trial also evaluated how the treatment affected scores on the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), a composite measure that assesses Parkinson’s motor and nonmotor symptoms and their impact on daily living.

Biovie said the trial successfully met its objectives, demonstrating statistically significant improvements over a placebo across MDS-UPDRS measures, including Part 3, which specifically evaluates motor symptoms. Bezisterim also significantly outperformed a placebo on the EPNIC-15 composite endpoint, a measure combining several clinically relevant motor and nonmotor items from the MDS-UPDRS with a standard measure of sleep quality. Most patients treated with bezisterim experienced stable or improved EPNIC-15 scores, whereas patients in the placebo group showed a pattern of worsening scores.

“Non-motor symptoms such as sleep disturbances, fatigue, and autonomic dysfunction are consistently identified among the most burdensome and under-addressed concerns for people living with Parkinson’s disease,” said James Beck, PhD, chief scientific officer of the Parkinson’s Foundation. “The results of this trial could represent a meaningful advancement in Parkinson’s treatment and help to address a significant unmet need in care.”

Improvements in EPNIC-15 and subcomponents of the MDS-UPDRS were particularly pronounced among patients with high platelet levels, Biovie said. Platelets are cell fragments that help blood clot, and high platelet levels can reflect elevated inflammation in the body. These findings may have important implications for how future studies are designed, the company said.

“Improvement across both motor and non-motor domains of the MDS-UPDRS is encouraging because these measures represent clinically meaningful outcomes recognized by physicians, patients, and the FDA,” said Mark Stacy, MD, a professor at the Medical University of South Carolina. “The finding that treatment effects were greater in patients with higher platelet levels supports the rationale that reduction in neuronal inflammation remains an unmet need in neurodegenerative disease. It may also provide guidance for evaluating a more targeted patient population in future studies.”

Biomarker data also broadly indicated that bezisterim reduced markers of inflammation and nerve cell damage relative to a placebo. The therapy was also well tolerated, and no serious safety issues were reported during the study.

“Topline results of the SUNRISE-PD trial are encouraging and demonstrate the potential for bezisterim to address significant unmet clinical needs in Parkinson’s disease through a differentiated therapeutic approach that targets the underlying disease biology, rather than focusing solely on symptomatic treatment provided by currently approved therapies,” said Cuong Do, president and CEO of Biovie. “These exploratory results suggest that bezisterim may have the potential to become the first drug candidate to improve clinical outcomes in Parkinson’s disease beyond motor symptoms.

The drug showed “a potentially differentiated profile, with effects on underlying … biomarker endpoints, potential neurodegenerative benefits, and improvements across both motor as well as non-motor clinical outcomes,” Do said. “Collectively, these results highlight bezisterim’s potential to represent a meaningful advance in Parkinson’s disease treatment and provide a strong foundation for its continued clinical development.”