An edited microscopic image of medium spiny neurons (yellow) with nuclear inclusions (orange), which occur as part of the Huntington’s disease process. Credit: Leevanjackson.

Teva Pharmaceutical Industries has reported negative outputs from the LEGATO-HD trial after it failed to meet the primary endpoint.

LEGATO-HD is a Phase ll, multicentre, multinational, randomised, double-blind, placebo-controlled, parallel-group trial investigating the safety and efficacy of laquinimod to treat patients with Huntington’s disease (HD).

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As part of the trial, three daily dose arms including 0.5mg, 1.0mg, and 1.5mg were evaluated against placebo.

Teva, however, discontinued the 1.5mg arm in January 2016 as a precautionary safety measure.

A total of 352 patients with a mean of 43.9 years, mean Unified Huntington’s Disease Rating Scale Total Motor Score (UHDRS-TMS) score of 24.4, and mean UHDRS-Total Functional Capacity (TFC) score of 11.1were randomised during the trial.

Altogether, 287 patients completed the trial, while 65 terminated early, including 30 patients who stopped study when the 1.5mg dose was terminated.

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“As part of the trial, three daily dose arms including 0.5mg, 1.0mg, and 1.5mg were evaluated against placebo.”

The LEGATO-HD trial’s primary endpoint was the change from baseline at month 12 in the UHDRS-TMS for the 1.0mg dose compared to placebo.

Its secondary endpoint measured the percentage caudate atrophy from baseline at month 12 in the 1.0mg dose against placebo, which was met by the trial.

The exploratory objectives were the change in the UHDRS-TMS and the percentage caudate atrophy both for the 0.5mg dose, and changes in measures of motor function, cognitive function, functional capacity, as well as brain volumes for the 1.0mg and 0.5mg doses individually.

The trial’s safety measures were adverse event reporting, clinical laboratory tests, vital signs, electrocardiograms, physical examinations, and suicidality.

Teva Pharmaceutical Industries, along with Huntington Study Group and the European Huntington’s Disease Network, has sponsored the LEGATO-HD trial.

The company has previously partnered with Active Biotech to develop laquinimod, which is an orally administered small molecule with immunomodulatory properties and being developed for neurodegenerative diseases.

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