BioVie’s stock crashed after the biotech released data from its Phase IIb Parkinson’s disease trial that used a unique composite measure.
The SUNRISE-PD study (NCT06757010) was a multicentre, randomised, double-blind, placebo-controlled trial designed to establish proof-of-mechanism and proof-of-concept of bezisterim, an oral small-molecule, in patients with early-stage Parkinson’s disease who had not previously been treated with carbidopa/levodopa.
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The primary endpoint of the study was change in part three of the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), according to ClinicalTrials.gov.
In a presentation, BioVie used the MDS-UPDRS Part III to focus on the motor scale across different baseline platelet counts, a blood-based inflammatory biomarker. At low levels, placebo performed numerically higher, but at higher levels, bezisterim performed better.
The Phase IIb trial also evaluated motor and non-motor endpoints, clinician-rated outcomes, quality-of-life, and safety and tolerability measures.
The trial successfully met prespecified endpoints and achieved its objectives, with topline results showing that bezisterim improved blood-based inflammatory markers of disease, along with a broad range of biological markers associated with overall cellular health and nerve cell damage. Participants treated with bezisterim experienced greater improvements than those receiving placebo across a series of clinical outcome measures of daily living, motor symptoms, and non-motor symptoms.
The majority of patients treated with bezisterim showed a 0.4 point reduction on the Early Parkinson’s Neuro-Inflammatory Composite 15 (EPNIC-15), an endpoint collating 15 clinically relevant motor and non-motor measures of PD. In contrast, patients receiving placebo showed a change in the opposite direction, with a 0.18 point increase.
EPNIC-15 aligns clinical outcome measurements from UPDRS Parts I (non-motor symptoms), II (activities of daily living), and III (motor symptoms), as well as PDSS-2 (sleep).
This collated endpoint, however, is not used in other Parkinson’s disease studies, and only appears to be referenced by BioVie itself.
Dr Mark Stacy, William E. Murray professor of neurology at the Medical University of South Carolina, and paid consultant to BioVie, said: “Improvement across both motor and non-motor domains of the MDS-UPDRS is encouraging because these measures represent clinically meaningful outcomes recognised by physicians, patients, and the FDA. 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.”
Investors seemed spooked by the data, as BioVie’s stock opened 33.3% down to $1.36 on 6 August, from a 5 August close of $2.04. At one point on 6 August, BioVie’s stock was down nearly 60%, hitting a low of $0.82; however, recovery during the day saw the company close at $1.35 – a 33.8% drop on the 5 August close. The company published the trial data in tandem with a filing to offer stock at $1.33 a share. BioVie is listed on the NASDAQ exchange under the ticker BIVI.
Bezisterim acts by selectively binding to extracellular signal-regulated kinases (ERK1/2) and blocking inflammation-driven ERK and NF-κB signalling.
GlobalData estimates the Parkinson’s disease market across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) was worth approximately $3.4bn in 2023. It is forecast to grow to $7bn by 2033 at a compound annual growth rate of 7.6%, driven by new therapies. Across the 68 global markets, sales are expected to rise from $5.7bn in 2023 to $12.4bn in 2033.
GlobalData is the parent company of Clinical Trials Arena.
