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LianBio to discuss Phase 3 LIBRA results with China NMPA
The Fly

LianBio to discuss Phase 3 LIBRA results with China NMPA

LianBio announced topline results from the Phase 3 LIBRA clinical trial evaluating TP-03 in Chinese patients with Demodex blepharitis. The co-primary endpoints of the LIBRA trial were mite eradication and complete collarette cure at day 43. Results demonstrated statistically significant mite eradication in patients with Demodex blepharitis treated with TP-03 compared to vehicle. A positive, but not statistically significant trend was also observed for complete collarette cure. TP-03 was well tolerated with a safety profile similar to that observed in other large-scale clinical trials, and there were no treatment-related discontinuations. LianBio plans to discuss these results with the China National Medical Products Administration NMPA and expects to use these data to support a New Drug Application filing in China “We are pleased that the LIBRA trial demonstrated significant Demodex mite eradication, the primary etiology of Demodex blepharitis, as well as a favorable safety profile

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