(Reuters) -Viridian Therapeutics’ experimental treatment for chronic thyroid eye disease (TED) significantly reduced symptoms such as double vision and eye bulging in a late-stage study, sending its shares surging more than 26%.
The success of the antibody drug, veligrotug, follows a separate late-stage study in September where it helped reduce symptoms in patients with active or early phase of the immune system condition.
TED causes inflammation and damage to the tissues around the eye and is estimated to affect between 90 and 300 per 100,000 people in the U.S.
Viridian is “uniquely positioned … with line-of-sight to an approved drug in a validated commercial market in 2026 and a clear M&A candidate heading into 2025,” Stifel analyst Alex Thompson said.
Analysts also expect veligrotug to become the first rival to Amgen’s blockbuster therapy Tepezza, offering a more convenient treatment option for patients.
Tepezza requires a total of eight intravenous infusions, each of which takes 60 to 90 minutes, compared to Viridian’s drug that requires five 30-minute infusions.
“This is no longer simply about shorter infusion times and course of therapy,” CEO Steve Mahoney said. The drug’s “differentiated clinical profile in (the study) just changed the game for chronic TED patients”.
Viridian said its drug helped 48% of patients, when adjusted for placebo rates, achieve at least a 2-millimeter reduction in eye bulging after 15 weeks of treatment.
It helped 18% of patients, when adjusted for placebo rates, achieve complete resolution of diplopia or double vision.
The 188-member study enrolled patients who have had the disorder for about six years on average.
Adjusted for placebo rates, 9.6% of patients experienced treatment-related mild-to-moderate hearing impairment.
Viridian plans to include data from both the trials as part of its marketing application to support the drug’s labeling, Mahoney said.
The drug developer plans to apply for a U.S. approval in the second half of 2025 and expects a potential launch in 2026.
(Reporting by Mariam Sunny in Bengaluru; Editing by Shilpi Majumdar)
Source link : https://www.medscape.com/s/viewarticle/viridian-shares-soar-after-latest-trial-success-thyroid-eye-2024a1000n7g?src=rss
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Publish date : 2024-12-16 12:10:07
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