US-based biotechnology company Viridian Therapeutics has announced plans to begin two Phase III clinical trials of the anti-IGF-1R antibody, VRDN-003, to treat moderate-to-severe thyroid eye disease (TED).
Named REVEAL-1 and REVEAL-2, the trials aim to assess the efficacy and safety of the subcutaneous doses of VRDN-003 in people with both active and chronic TED, respectively.
Go deeper with GlobalData
The two double-masked, randomised, placebo-controlled trials are due to begin in August this year.
REVEAL-1 will involve nearly 84 subjects, who will be randomised in a 1:1:1 ratio to receive either VRDN-003 or a placebo every four or eight weeks.
The dosing will begin with a 600mg loading dose, administered as two 300mg injections, followed by 300mg injections at subsequent intervals.
The REVEAL-2 trial will include around 126 patients undergoing the same randomisation and dosing regimens.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataProptosis responder rate, as assessed by a minimum of 2mm improvement in proptosis at week 24 compared to baseline, will be the primary endpoint for both trials.
Viridian expects to release top-line data from these trials in the first half of 2026 and aims to submit a biologics license application (BLA) by the end of that year.
Viridian Therapeutics president and CEO Steve Mahoney said: “We are very pleased to have completed a positive Type C meeting with the FDA and to take this next step towards rapidly bringing a highly differentiated treatment option to patients living with TED.
“We view VRDN-003 as a potentially best-in-class anti-IGF-1R product candidate that is designed to preserve the compelling IGF-1R clinical response we have seen in our earlier proof-of-concept studies of VRDN-001.
“We believe this product profile could maximise convenience as a low-volume, infrequent subcutaneous injection and provide better access to treatment for patients.”
Based in Massachusetts, Viridian Therapeutics aims to develop potential best-in-class medicines for patients with serious and rare diseases.
