Horizon posts positive Phase 4 data for thyroid eye disease therapy Tepezza
Dr_Microbe
Horizon Therapeutics (NASDAQ:HZNP) announced Monday that its thyroid eye disease (TED) therapy Tepezza reached the primary endpoint in a Phase 4 trial, indicating a statistically significant reduction in TED symptom proptosis.
The randomized placebo-controlled trial was designed to evaluate Tepezza in 42 patients against 20 of those who received a placebo.
The trial participants were adults with an initial diagnosis of TED two to 10 years before the screening. They also indicated a low Clinical Activity Score (CAS), a measure of disease activity.
Citing topline data after 24 weeks of therapy, Horizon (HZNP) said that the trial reached the primary endpoint as patients on Tepezza achieved a statistically significant 2.41 mm reduction in proptosis from baseline compared with 0.92 mm in the placebo group.
62% of patients in the Tepezza also demonstrated a clinically meaningful improvement in proptosis compared to 25% in the placebo group.
There were no new safety signals for the treatment, approved by the FDA in 2020 as the first U.S.-authorized treatment for TED.
The company intends to discuss the data with the FDA to determine its next regulatory steps for Tepezza.
In March, Seeking Alpha contributor Daniel SchÃ¶nberger downgraded Amgen (AMGN), which has agreed to acquire HZNP, arguing that âwhile the acquisition might make sense it is increasing the total debt to rather extreme levels.â