Viridian Therapeutics’ elegrobart normalized the degree of eye protrusion and improved double vision in a Phase 3 study. The company plans to file for approval in the first quarter of 2027.
Viridian Therapeutics’ thyroid eye disease drug significantly normalized the degree of eye protrusion in a Phase 3 study of thyroid eye disease, setting the stage for a potential comeback in this indication.
In REVEAL-2, data from which were unveiled in a news release on Tuesday, one dose of elegrobart every four weeks resulted in a proptosis responder rate (PRR) of 50%, versus 15% for placebo at 24 weeks. Proptosis refers to the abnormal protrusion of the eyes, a common symptom in thyroid eye disease (TED).
The treatment effect was statistically significant in favor of elegrobart. The same was true for treatment given every eight weeks, with a PRR of 54%.
Alongside proptosis response, Viridian on Tuesday also touted positive benefits of elegrobart for double vision, or diplopia.
“We believe these results strengthen the clinical profile for elegrobart,” analysts at William Blair told investors on Tuesday. “With two positive, large Phase III studies now in hand, elegrobart looks approvable and commercially competitive.”
These results point to elegrobart’s “IV-like efficacy in a convenient, self-administered subcutaneous therapy with as few as four administrations” for a complete course, the analysts added.
Truist Securities was more direct about elegrobart’s competitive edge, writing in a Tuesday note that the drug’s “more-convenient offering could bring a large proportion of the TED patients off the sidelines.”
Approximately 30% of patient candidates for Amgen’s Tepezza “opt to stay off therapy given the logistical/administrative burden,” the analysts added. Elegrobart, if approved, could provide these patients with a more acceptable treatment option.
The new data vindicate the company and elegrobart, after an underwhelming readout in March from the Phase 3 REVEAL-1 trial, which found placebo-adjusted PRR ranging from 36% to 45%, falling behind the investor expectation of 51% to 73%.
Viridian’s stock crashed by as much as 33% in the aftermath of these results. With Tuesday’s new data, however, the biotech soared nearly 39% to $18.75 by market close yesterday, though the price bump still isn’t enough to recoup Viridian’s initial loss in March.
Viridian plans to file an approval package for elegrobart in the first quarter of 2027, according to its Tuesday release.
