BioVie has reported topline results from a Phase 2 trial evaluating bezisterim in people with early-stage Parkinson’s disease, with the experimental therapy showing improvements across clinical measures and inflammatory biomarkers compared with placebo.

The SUNRISE-PD trial evaluated whether bezisterim could influence biological pathways associated with Parkinson’s disease, including inflammation and neuronal damage.

The randomised, double-blind, placebo-controlled Phase 2 study enrolled 57 adults with early-stage Parkinson’s disease who had not previously received carbidopa/levodopa treatment. The trial assessed motor and non-motor symptoms, quality of life measures, safety and blood-based biomarkers.

BioVie said patients treated with bezisterim showed improvements compared with placebo across MDS-UPDRS Parts I, II and III, which measure non-motor symptoms, activities of daily living and motor symptoms.

Bezisterim targets inflammation in Parkinson’s disease

Parkinson’s disease is a progressive neurological disorder associated with the loss of dopamine-producing neurons and a range of motor and non-motor symptoms. Inflammation is increasingly being investigated as a potential contributor to disease progression.

The SUNRISE-PD trial evaluated bezisterim, an oral therapy designed to target inflammatory pathways involved in neurodegeneration.

The company reported that bezisterim treatment was associated with improvements in several biomarkers linked to neuroinflammation, including CCL2, CHI3L1 and VGF, as well as markers of systemic inflammation.

BioVie also reported changes across a wider panel of proteins associated with inflammation, with 283 of 380 proteins shifting in a direction consistent with a lower inflammatory burden.

The treatment group also showed changes in biomarkers associated with neuronal injury, including neurofilament light chain (NfL), GFAP, UCHL1, BN02 and MAPT.

These biomarker findings are exploratory and further clinical studies will be needed to determine whether bezisterim can influence long-term disease progression.

Cuong Do, president and chief executive officer of BioVie, said: “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.”

Trial supports future Phase 3 planning

The majority of patients treated with bezisterim showed improvement on EPNIC-15, a composite measure combining 15 clinically relevant motor and non-motor Parkinson’s disease outcomes.

BioVie said treatment effects appeared stronger among participants with higher baseline levels of inflammation, identified through platelet concentration measurements. The company said this could help guide patient selection strategies in future studies.

Mark Stacy, professor of neurology at the Medical University of South Carolina, 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.”

Bezisterim shows favourable safety profile

The company reported that bezisterim was generally well tolerated, with adverse events occurring in 39.3% of participants receiving treatment compared with 51.7% in the placebo group.

No severe or serious adverse events were reported, and most adverse events were described as mild.

Joseph Palumbo, chief medical officer at BioVie, said: “We are encouraged by the clinical, biomarker, proteomic, 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.”

BioVie said the findings will support planning for future clinical development, including a potential registration study.