Viridian unveils initial Phase 3 eye disease results to rival Tepezza

Viridian Therapeutics unveiled promising Phase 3 data for its experimental drug veligrotug, aimed at treating thyroid eye disease (TED), an autoimmune condition. This data positions veligrotug to potentially rival Tepezza, a treatment developed by Amgen and Horizon.

The 113-patient trial demonstrated significant efficacy, with veligrotug meeting all primary and secondary endpoints. After 15 weeks of treatment, 70% of patients in the active treatment group showed a positive response in proptosis reduction, compared to just 5% in the placebo group. The placebo-adjusted proptosis responder rate (PRR) was observed to be 64%.

These results keep Viridian on schedule for seeking FDA approval in the latter half of 2025. Additionally, Viridian is conducting another Phase 3 trial focused on chronic TED, and the outcomes of both trials will form the cornerstone of their FDA submission.

Following the release of this data, Viridian’s stock ($VRDN) saw an 11% increase in premarket trading. Analyst Thomas Smith from Leerink had previously shared his expectations for veligrotug, noting that the results fit within his “base case” scenario. He deemed the data to be "generally competitive and consistent" with the performance metrics of Tepezza.

However, it is worth noting that Tepezza's Phase 3 study, which extended to 24 weeks, reported an 83% absolute PRR and a 73% placebo-adjusted PRR. Although veligrotug’s trial was shorter in duration, these results still suggest strong potential for the drug in the TED treatment landscape.

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