LianBio announces topline results from phase III LIBRA trial of TP 03 in Chinese patients with Demodex blepharitis

LianBio a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, announced topline results from the Phase III LIBRA clinical trial evaluating TP 03 in Chinese patients with Demodex blepharitis.

The co-primary endpoints of the LIBRA trial were mite eradication (mite density of 0 mites per lash) and complete collarette cure (collarette score of 0) at day 43. Results demonstrated statistically significant mite eradication in patients with Demodex blepharitis treated with TP 03 compared to vehicle (p<0.001). A positive, but not statistically significant trend (p=0.15) 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.

“Demodex blepharitis patients often experience significant impacts to their daily activities, and there are currently no approved medicines in China that eradicate the root cause of disease – the Demodex mite,” said Professor Zuguo Liu, M.D., Ph.D., Director of Xiamen Eye Center of Xiamen University, Principal Investigator of the LIBRA study. “I am highly encouraged by the results of the LIBRA trial, which demonstrate TP 03’s ability to drive statistically and clinically significant mite eradication in Chinese patients with Demodex blepharitis.”

LIBRA is a Phase III multicenter, double-blind, randomized, vehicle-controlled registrational study that evaluated the efficacy and safety of TP-03 in Chinese adult patients with Demodex blepharitis, with an open-label pharmacokinetics sub-study..

LianBio in-licensed rights from Tarsus Pharmaceuticals for the development and commercialization of TP 03 in Mainland China, Hong Kong, Macau and Taiwan..