Viridian Therapeutics Reports Positive Topline Veligrotug Phase 3 THRIVE-2 Clinical Trial Results

December 16, 2024

DENVER, Colo., Dec 16, 2024 (247marketnews.com)- Viridian Therapeutics (NASDAQ: VRDN) reported positive topline data from the THRIVE-2 phase 3 clinical trial, which met all primary and secondary endpoints at the 15-week primary analysis timepoint after five infusions of veligrotug, showing statistically significant responses on all of the measured signs and symptoms of chronic thyroid eye disease (TED), and was generally well-tolerated with 94% of patients completing their treatment course

Steve Mahoney, Viridian’s President and CEO, commented, “We are extremely pleased to announce better-than-expected THRIVE-2 results generated in the broadest population of chronic TED patients studied in a global phase 3 study to date. We believe that these efficacy and safety results in only five infusions, combined with our compelling data from THRIVE, confirm the potential of veli to be the treatment-of-choice for all forms of active and chronic TED.

“The robustness and consistency of our data, similar to THRIVE, showed strong and rapid responses in categories that we believe matter most to patients including proptosis reduction, diplopia resolution and improvements in Clinical Activity Scores. This is the first product candidate to demonstrate a diplopia response and resolution rate in a global chronic TED phase 3 study. Our BLA preparation work is underway, and, if approved, we now believe veli will offer a differentiated commercial product profile to patients. The combined results of THRIVE and THRIVE-2, give us even higher conviction that our subcutaneous VRDN-003 program will deliver positive topline data in the first half of 2026, which would enable a BLA submission in the second half of 2026.”

Associate Clinical Professor of Ophthalmology, Stein Eye Institute, University of California Los Angeles and THRIVE-2 investigator, Steven Leibowitz, M.D., stated, “These data represent an incredible step forward for TED patients. I’ve been treating TED for over 30 years, and these results in the broadest population of TED patients are highly encouraging. Resolving double vision or even improving it in chronic TED patients can really change their lives. I see veligrotug’s potential product profile as highly compelling with a rapid onset of treatment effect, diplopia benefit across a broad TED population, shorter dosing regimen, and favorable safety profile.”

Tony Casciano, Viridian’s Chief Commercial Officer, added, “Seeing the strong data presented today demonstrating that diplopia can in fact be improved in patients with long standing chronic TED is exciting. Together with the robust activity in both THRIVE and THRIVE-2, favorable safety profile, and a shorter dosing regimen, we believe veli is positioned to become a market leading TED therapeutic. Veli has the potential to be the only approved therapy with data in chronic patients included in the labeling. We believe the strength and completeness of veli’s pivotal program, the largest to date in TED, could not only ensure advantageous market access, but also expand utilization in patients unaddressed by current therapies. Veli’s profile itself is inspiring, and if approved, our commercial team is eager to get veli to patients.”

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