Two Phase III studies of KX2 391 meet primary endpoint in actinic keratosis.- Athenex.

Athenex announced that both Phase III studies, KX-AK-003 and KX-AK-004, of KX2 391 ointment had achieved their primary endpoint of 100% clearance of actinic keratosis (AK) lesions at Day 57 within the face or scalp treatment areas, with each study achieving statistical significance (p<0.0001). statistical significance (p><0.001) was achieved for both face and scalp subgroups as well. these two double-blind, randomized, vehicle-controlled, studies were designed as pivotal phase iii efficacy and safety studies to support the registration of kx2 391 as field therapy for ak of the face and scalp. the studies, each conducted at 31 centers in the usa, enrolled a total of 702 subjects. kx2 391, or vehicle ointment, was applied once daily for 5 days. in addition to the clinical activity of kx2-391, the local skin reaction (lsr) profile was within expectations, in line with the phase ii study reported in the annual american academy of dermatology (aad) meeting in february 2018 in san diego.>

Following an End of Phase II meeting with the United States Food and Drug Administration (US FDA), these two parallel Phase III pivotal studies were initiated in September 2017. In February 2018, Athenex announced that the recruitment had been completed ahead of schedule. Both studies are still on-going to complete the one-year follow-up of the patients who had complete responses. Athenex will be submitting a request to the US FDA for a pre-NDA submission meeting to discuss the data and regulatory submission timelines. The Company plans to submit the topline and other related data from the Phase III studies for presentation at an upcoming scientific meeting.