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.
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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.
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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.
