Horizon Therapeutics' thyroid eye disease drug Tepezza enters Phase 4 clinical trials

Horizon Therapeutics recently announced that a Phase 4 clinical trial (NCT04583735) evaluating the efficacy and safety of Tepezza (teprotumumab) in the treatment of chronic (inactive) thyroid eye disease (TED) has enrolled the first patient

Tepezza is the first and only drug approved by the US FDA for the treatment of TED.

TED begins in the acute (active) phase, during which the signs and symptoms of inflammation, such as eye pain, swelling, exophthalmos (eyeball), and diplopia, progress over time

This randomized, double-blind, placebo-controlled, parallel-group, multi-center Phase 4 trial will evaluate the efficacy, safety and tolerability of Tepezza and placebo in the treatment of chronic TED patients

The primary efficacy endpoint is the change from baseline in exophthalmos (eyeball) in the study eye at week 24

Thyroid ophthalmopathy (TED) is a progressive and debilitating autoimmune disease.

Active TED lasts up to 3 years and is characterized by inflammation and tissue expansion behind the eye

In the past, patients had to go through active TED until the disease became inactive (which usually left permanent and visually impaired consequences) before performing complex and expensive surgery, but surgery may never restore vision or appearance

Tepezza’s active pharmaceutical ingredient, teprotumumab, is a fully human IgG1 monoclonal antibody that targets insulin-like growth factor-1 receptor (IGF-1R).

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Original source: Horizon Therapeutics plc Initiates Randomized Controlled Clinical Trial Evaluating TEPEZZA (teprotumumab-trbw) for the Treatment of Chronic (Inactive) Thyroid Eye Disease (TED)