Clinical Activity Score (“CAS”):
| | • | | CAS Reduction to 0 or 1: 64% of patients receiving veligrotug achieved maximal or near-maximal therapeutic effect on CAS, compared with 18% of patients receiving placebo (46% placebo-adjusted) (p < 0.0001), defined as reaching a CAS of 0 or 1. CAS measures inflammatory signs and symptoms of TED, providing a composite score of pain, as well as redness and swelling of the eyelids and conjunctiva, on a scale from 0 to 7. |
| | • | | CAS Mean Reduction: 3.4-point mean reduction in CAS from baseline for patients receiving veligrotug, compared with 1.7-point reduction in patients receiving placebo (1.7-point placebo-adjusted) (p < 0.0001). |
Overall Response:
| | • | | Overall Responder Rate: 67% of patients receiving veligrotug achieved an overall response, compared with 5% of patients receiving placebo (61% placebo-adjusted) (p < 0.0001). Overall Responder Rate is defined as achieving a proptosis response and a ≥2-point reduction in CAS from baseline without worsening in the fellow eye in either proptosis (2mm increase) or CAS (2-point increase). |
THRIVE Safety Data
| | • | | Generally Well-Tolerated: Veligrotug was generally well-tolerated with a safety profile consistent with previous veligrotug studies. The majority of adverse events (“AEs”) were mild, and there was a low rate (4%) of discontinuations in the veligrotug arm. There were no treatment-related serious AEs. |
| | • | | Low Rate of Hearing Impairment: There was a 5.5% placebo-adjusted rate of hearing impairment AEs in THRIVE (16% incidence in patients receiving veligrotug, compared with 10.5% incidence in patients receiving placebo). |
Clinical Update
The Company also announced that the second phase 3 clinical trial of veligrotug, THRIVE-2, in patients with chronic TED is ongoing. Viridian completed enrollment of THRIVE-2 in July 2024, and topline data readout is on track for year-end 2024. Viridian anticipates submitting a biologics license application (“BLA”) for veligrotug for the treatment of TED in the second half of 2025, as planned.
Viridian believes these topline results from THRIVE provide strong support for a potential best-in-class profile of VRDN-003, an IGF-1R antibody with the same binding domain as veligrotug, with the potential to deliver clinical efficacy and safety consistent with veligrotug in a low-volume, infrequent, self-administered, subcutaneous injection that patients take at home. Viridian initiated two global Phase 3 clinical trials for VRDN-003 in August 2024 as planned: REVEAL-1 and REVEAL-2 in active and chronic TED, respectively. Both trials will evaluate VRDN-003 subcutaneously administered every four weeks or eight weeks and will assess outcomes versus placebo. Viridian anticipates topline data from both trials in the first half of 2026, with a BLA submission for VRDN-003 for the treatment of TED by year-end 2026.
Forward Looking Statements
This Current Report on Form 8-K contains forward-looking statements. These statements may be identified by the use of words such as, but not limited to, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “on track,” “plan,” “potential,” “predict,” “project,” “design,” “should,” “target,” “will,” or “would” or other similar terms or expressions that concern our expectations, plans and intentions. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations, and assumptions. Forward-looking statements include, without limitation, statements regarding: Viridian’s view that the THRIVE data provides strong support for VRDN-003’s clinical profile; milestones; timelines; anticipated data results and timing of their disclosure, including topline results; regulatory interactions and anticipated timing of regulatory submissions, including the anticipated BLA submission for
