Viridian Therapeutics, Inc. has announced positive long-term durability data from the Phase 3 Thrive clinical trial of Veligrotug ("Veli"), an intravenously delivered anti-insulin-like growth factor-1 receptor (IGF-1R) antibody, in patients with active thyroid eye disease (TED). The data revealed that 70% of patients treated with Veli in the Thrive study who were proptosis responders at week 15 maintained their response at week 52. This maintenance of response is defined as responders at week 15 who still had at least a 2-millimeter reduction in proptosis compared to baseline at week 52, without worsening in the fellow eye.
Furthermore, the safety profile remained stable, with the vast majority of adverse events reported at the week 15 primary analysis having resolved by week 52. Steve Mahoney, Viridian’s President and CEO, expressed confidence in Veli's clinical data, stating that it demonstrates the potential for Veli to be the treatment of choice for patients living with TED. He also mentioned that Veli's streamlined dosing regimen of five infusions positions it to become a market-leading TED therapeutic if approved.
In late 2024, Veligrotug met all of its primary and secondary endpoints and was generally well-tolerated in its pivotal Phase 3 clinical trials, Thrive and Thrive-2, for active and chronic TED, respectively. Veligrotug demonstrated a rapid onset of treatment effect and statistically significant and clinically meaningful reduction and resolution of diplopia in both clinical trials.
Veligrotug is an IV-delivered anti-IGF-1R antibody in Phase 3 development for TED, with the potential to be the IV treatment of choice for active and chronic TED patients. The company believes that the robust Veligrotug clinical profile has the potential to establish a strong position in the TED commercial market if approved.
Viridian Therapeutics, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing potential best-in-class medicines for patients with serious and rare diseases. The company is advancing multiple candidates in the clinic for the treatment of patients with TED and is also advancing a novel portfolio of neonatal FC receptor (FCRN) inhibitors, which have the potential to be developed in multiple autoimmune diseases. Today the company's shares have moved -0.93% to a price of $12.82. For more information, read the company's full 8-K submission here.
