Lyra Therapeutics clears path to Phase III for new ENT treatment option

USA-based drug developer Lyra Therapeutics (Nasdaq: LYRA) saw its shares gain more than 14% to $9.00 in pre-market trading today, as it announced the positive outcome of the company’s end-of-Phase II meeting with the Food and Drug Administration, establishing the key elements of the upcoming Phase III study for LYR-210, the company’s lead product candidate for the treatment of chronic rhinosinusitis.

This and other recent news show Lyra’s momentum in the ENT (ear, nose and throat) therapeutics area, and clears the regulatory path to Phase III. Last week Lyra announced a $135 million international strategic partnership and license agreement with Sino-American biotech firm LianBio for developing LYR-210 in Asia.

Based on the Agency’s suggestion, Lyra intends to enroll a total of around 350 subjects split into two replicate, largely concurrent Phase III clinical trials, each powered to >95% to detect statistical significance. Both studies will evaluate a 7500µg dose of LYR-210, and additional key clinical aspects of the studies will also be the same.