Viridian Therapeutics has announced encouraging topline results from its REVEAL‑1 phase 3 clinical trial evaluating elegrobart in patients with active thyroid eye disease.
The study tested two subcutaneous dosing schedules – every four weeks and every eight weeks – against placebo. According to the company, both regimens achieved clinically meaningful improvements in proptosis, with responder rates of 54 percent and 63 percent respectively, compared with 18 percent for placebo at week 24. More than half of patients receiving the four‑week dose also saw complete resolution of diplopia.
Steve Mahoney, President and Chief Executive Officer of Viridian Therapeutics, said: “We are excited to report these results from REVEAL‑1, the largest pivotal clinical trial conducted in active TED to date, which position elegrobart as potentially the first ever subcutaneous autoinjector treatment for TED.” He added: “REVEAL‑1 met its primary endpoint with high statistical significance. Elegrobart treatment drove robust proptosis responses in a treatment regimen comprised of as few as three subcutaneous doses.”
Mahoney explained that the current marketed therapy requires eight intravenous infusions and generates significant annual revenues despite limited uptake. He said: “We believe there is a significant opportunity with subcutaneous elegrobart in TED, including the potential to expand the market as an at‑home and self‑administered treatment option, if approved.”
Prem Subramanian, professor of ophthalmology at Colorado University Anschutz, said: “Subcutaneous elegrobart showed rapid and clinically meaningful reductions in proptosis and diplopia in REVEAL‑1 with a highly convenient, well‑tolerated dosing profile.” He added: “Patients are seeking more treatment choices for TED, and there remains a clear need for a more conveniently administered therapy.”
Viridian also confirmed that REVEAL‑2, a phase 3 trial in chronic thyroid eye disease, remains on track for a topline readout in the second quarter of 2026, with a regulatory submission expected the following year.
