Viridian Therapeutics has announced encouraging long-term durability data from its pivotal Phase III THRIVE clinical program evaluating veligrotug (“veli”) for the treatment of active thyroid eye disease (TED).
The new findings reinforce veligrotug’s sustained efficacy, safety and potential to become a new therapeutic option for TED, according to Viridian.
TED, also known as Graves’ eye disease, is an autoimmune condition characterized by inflammation, growth and damage to tissues around and behind the eye. Symptoms can include eye bulging (proptosis), double vision (diplopia) and eye pain. Effective treatments are essential to manage these symptoms and improve patients’ quality of life.
As announced in late 2024, veligrotug achieved all primary and secondary endpoints and was generally well tolerated in its pivotal Phase III trials — THRIVE for active TED and THRIVE-2 for chronic TED.
The treatment delivered a rapid onset of action along with statistically significant and clinically meaningful reductions — and in some cases, resolution — of diplopia in both studies.
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The THRIVE Phase III study assessed the efficacy and safety of veligrotug in patients with active TED. Participants received either veligrotug or placebo via five infusions, each spaced three weeks apart. The trial’s primary analysis occurred at Week 15, with extended follow-up continuing through Week 52.
Results from the trial showed that 70% of veligrotug-treated patients (21 out of 30) who were proptosis responders at Week 15 maintained their response at Week 52.
THRIVE-2 marked the first global Phase III trial in chronic TED to demonstrate statistically significant improvements in diplopia. Together, THRIVE and THRIVE-2 represent the largest pivotal clinical program in TED to date.
Veligrotug was generally well tolerated, reinforcing its potential as a safe and effective treatment option for TED. The safety profile remained stable, with no new safety signals observed during the extended follow-up. Most adverse events reported at Week 15 resolved by Week 52.
Veligrotug is an investigational intravenous (IV) anti-IGF-1R antibody. Viridian is hoping the drug has the potential to become the “IV treatment-of-choice” for both active and chronic TED patients.
IGF-1R is a well-established therapeutic target in TED, with US market revenues of IGF-1R inhibitors reaching approximately $2 billion in 2024, according to Viridian’s press release announcing the latest trial data for veligrotug.
Viridian says veligrotug aims to enhance the patient experience through a differentiated dosing regimen, offering a shorter infusion time and fewer infusions compared to the currently approved IGF-1R inhibitor.
“We view the strength of today’s durability and safety resolution data as reinforcing veli’s strong and consistently robust clinical profile,” said Viridian’s president and CEO, Steve Mahoney.
“We believe that the totality of veligrotug’s clinical data continues to demonstrate its potential to be the treatment-of-choice for patients living with TED. We believe these data, together with a streamlined dosing regimen of five infusions, position veli to become a market leading TED therapeutic, if approved. We continue to make great progress towards submitting the [Biologics License Application] BLA in the second half of this year and preparing for a potential launch in 2026.”
Regulatory Plans and TED Market
Veligrotug recently received Breakthrough Therapy designation from the FDA, making it eligible for Priority Review.
Viridian says the designation was granted based on clinical data demonstrating veligrotug’s consistent and robust improvement, and in some cases, resolution, of diplopia in patients with chronic TED, as well as its rapid onset of proptosis response.
Viridian Therapeutics remains on track to submit a BLA for veligrotug in the second half of 2025.
In anticipation of potential approval, the company said it is actively preparing its organization for a planned US commercial launch in 2026.
The company is also planning to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) this year.
Other companies developing TED therapies include Sling Therapeutics, whose oral therapy linsitinib achieved the primary endpoint of reducing proptosis in its Phase IIb/III LIDS trial for TED. Sling says linsitinib is the first oral small molecule to demonstrate statistical and clinical significance in the condition.
The current TED market leader is Amgen’s Tepezza (teprotumumab-trbw), an IV monoclonal antibody targeting IGF-1R. Originally developed by Horizon Therapeutics and acquired by Amgen in 2023, the drug was first approved in 2020 as the first and only treatment for TED.
In 2024, Tepezza generated $1.9 billion in global sales, with $460 million coming from the fourth quarter alone. Its main markets were the US and Japan.
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