Almirall announced that both phase 3 studies of KX2-391 for actinic keratosis (AK), met the primary endpoint of complete clearance of AK lesions at Day 57 within the face or scalp treatment areas, each study achieving statistical significance (P < 0.0001) on this endpoint. Statistical significance (P < 0.001) was also achieved for both face and scalp subgroups.
These double-blind, randomized, vehicle-controlled, studies were designed as pivotal phase 3 efficacy and safety studies to support the registration of KX2-391 (or KX-01) as field therapy for AK of the face and scalp. The studies, conducted in 31 centers in the USA, enrolled a total of 702 patients. 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 profile was in line with the prior phase 2 study results reported in the annual American Academy of Dermatology (AAD) meeting in February 2018 in San Diego.
KX2-391, also known as KX-01, is a first-in-class dual Src kinase and tubulin polymerization inhibitor in phase 3 development as a topical medicinal product for the treatment of AK, the most common pre-cancerous dermatological condition. AK affects more than 55 million Americans and accounts for between 14% and 29% of dermatologist visits in the USA.
Source: Almirall.com, July 26, 2018