Biohaven has commenced a randomised Phase II/III trial of the tyrosine kinase 2 (TYK2) / Janus Kinase 1 (JAK1) inhibitor, BHV-8000, aimed at treating early Parkinson’s disease (PD).
The global, placebo-controlled, double-blind trial is designed to evaluate the safety and efficacy of 10mg and 20mg of the therapy against a placebo.
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It will enrol 550 subjects across nearly 185 sites in 13 nations, including Canada, the US, and 11 European countries.
The trial’s primary endpoint is a time-to-event analysis based on the changes in the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part II.
This scale is recognised by the US Food and Drug Administration (FDA) to support the registration.
In addition, the trial incorporates the use of first-in-clinic PD composite scales (PARCOMS), aiming to enhance the sensitivity of detecting meaningful changes in early PD patients’ function.
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By GlobalDataIn the previous Phase I programme, the therapy demonstrated a good safety profile, without any serious adverse events or concerning trends in laboratory values reported.
BHV-8000 is not only being investigated for early PD but is also in development for other neuroinflammatory conditions such as Alzheimer’s disease and multiple sclerosis, as well as the prevention of amyloid-related imaging abnormalities (ARIA) in individuals starting anti-amyloid treatments.
Biohaven clinical development senior vice-president Pete Ackerman said: “We are proud to announce the initiation of our pivotal clinical trial in early PD for BHV-8000, a novel therapy with broad potential for treating neuroinflammatory and neurodegenerative diseases.
“There are currently no available disease-modifying therapies to treat PD, a devastating and relentlessly progressive neurological disorder whose global prevalence is expected to double by 2050.”
Last year, the company dosed the first participant in a Phase I/II trial of BHV-1510, a Trop-2 directed antibody-drug conjugate (ADC) for treating advanced or metastatic epithelial cell tumours.
