FDA grants rare pediatric disease designation to zaltenibart for C3 glomerulopathy
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Key takeaways:
- Zaltenibart is the most proximal inhibitor of the alternative pathway.
- Phase 3 clinical trials for the inhibitor in complement 3 glomerulopathy will begin in 2025.
The FDA has granted rare pediatric disease designation to Omeros Corporation’s zaltenibart for the treatment of complement 3 glomerulopathy, according to a press release.
“[Complement 3 glomerulopathy] C3G is devastating for children as well as for adults, and our receipt of FDA’s rare pediatric disease designation is a welcome acknowledgment of zaltenibart as a potential therapeutic for this disease that has no approved treatment,” Gregory A. Demopulos, chairman and CEO of Omeros, said in the release.
Complement 3 glomerulopathy is caused by dysregulation of the alternative pathway of complement and there is no approved treatment for C3G, which can lead to end-stage renal disease within 10 years of diagnosis, according to the release.
Zaltenibart (OMS906, Omeros) is the most proximal inhibitor of the alternative pathway. It blocks mannan-binding lectin-associated serine protease-3, the key activator of the alternative pathway, stopping the conversion of pro-complement factor D (pro-CFD) to mature CFD.
Phase 3 clinical trials for OMS906 in C3G are slated to begin in 2025. According to the release, Omeros is also studying the inhibitor for the treatment of paroxysmal nocturnal hemoglobinuria and has received orphan drug designation from FDA for the indication.
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