Horizon Therapeutics has announced positive topline results from its Phase IV clinical trial of TEPEZZA to treat adults with chronic thyroid eye disease (TED) and low clinical activity score (CAS), a measure of disease activity.
The randomised, double-masked, placebo-controlled, parallel-group, multicentre trial evaluated the safety, efficacy and tolerability of TEPEZZA (n=42) against placebo (n=20).
Adults with an initial diagnosis of TED between two to ten years and low disease activity levels, were enrolled in the study.
At week 24, the primary endpoint was met with a 2.41 mm reduction in proptosis from baseline against 0.92 mm in placebo. Additionally, the trial reported no new safety signals.
Horizon Research and Development executive vice-president Elizabeth Thompson said: “We are thrilled with the top line results, which reinforce that TEPEZZA significantly reduces proptosis in people living with Thyroid Eye Disease, regardless of their disease activity or duration, and underscores what we learned from our initial trials and what we have seen through more than three years of real-world use of TEPEZZA.
“With TEPEZZA, physicians have a medicine that can be used in a broad range of Thyroid Eye Disease patients, including those with long-duration disease of more than five years on average in this trial, which is important because we know the negative impact of the disease can be significant across all types of Thyroid Eye Disease patients.
“We look forward to discussing these data with the FDA to determine our next steps.”
In the Phase II and III pivotal trials of TEPEZZA, patients with disease duration of nine months or less and higher levels of disease activity were evaluated.