Viridian Therapeutics (NASDAQ: VRDN) stock jumped approximately 30 per cent because of the announcement of positive topline results from the Phase 3 THRIVE clinical trial of Veligrotug.
Released on Tuesday, the trial results successfully showed improvement in the signs and symptoms of thyroid eye disease (TED), meeting the primary goals. This development has drawn the attention of investors and market analysts, driving the stock’s upward movement due to the potential market for TED treatment and the demonstrated effectiveness in the trial.
These results not only highlight the drug’s potential in treating TED but also improve Viridian Therapeutics’ market position by showcasing their capability to advance in the biotechnology sector with promising treatments.
Thyroid eye disease is an autoimmune condition linked to thyroid disorders. This is where the immune system attacks the tissues around the eyes. This causes symptoms like eye bulging, double vision, swelling, and redness. It can lead to discomfort and, in severe cases, vision loss.
The drug significantly reduced proptosis (eye bulging), a primary symptom of TED. In the trial, 70 per cent of patients receiving veligrotug experienced at least a 2 mm reduction in proptosis, a clinically significant outcome. Additionally, 54 per cent of treated patients achieved a complete resolution of diplopia (double vision), demonstrating a strong therapeutic effect.
Analysts are comparing the results to Tepezza, a drug by Amgen Inc (NASDAQ: AMGN) already on the market for TED. Tepezza showed response rates of 71 and 83 per cent at week 24 in its trials. Veligrotug’s response rate and metrics suggest competitive, and potentially superior, performance in certain aspects. Furthermore, direct comparisons require caution due to differences in study conditions and patient populations.
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Thrive trial met all primary and secondary endpoints in 15 weeks
Veligrotug was well-tolerated with no treatment-related serious adverse events. However, hearing impairment events occurred in 16 per cent of patients in the veligrotug arm. This is higher than Tepezza’s reported 10 per cent, was influenced by the lower rate in the placebo group of the veligrotug study.
The THRIVE trial met the primary and all secondary endpoints at 15 weeks after five infusions of veligrotug, showing highly statistically significant improvements in all measured signs and symptoms of TED. Veligrotug also demonstrated a rapid onset of action, with most patients achieving a proptosis response after just one infusion, or three weeks from the start of therapy. The trial enrolled 113 patients, who were randomized to receive either veligrotug or placebo.
Viridian plans to file for approval in the second half of 2025, aiming for a potential market entry soon after. If the approval process proceeds smoothly, veligrotug could become a strong competitor to Tepezza, especially if it continues to deliver favorable results in further trials and analyses.
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