LEO Pharma reveals positive top-line Phase III results for tralokinumab

Danish dermatology specialist LEO Pharma says that tralokinumab – an investigational, fully-human monoclonal antibody that specifically neutralizes the interleukin-13 (IL-13) cytokine – met all primary and secondary endpoints in its three pivotal Phase III studies (ECZTRA 1-3) for the treatment of moderate-to-severe atopic dermatitis (AD) in adults. During the studies, the overall adverse event rate was comparable between tralokinumab and placebo.

IL-13 is a key driver of the type 2 inflammation that plays a major role in AD, which is the most common inflammatory skin disease in the developed world, affecting up to 5% of adults across the USA, Canada, Europe and Japan. AD can have a significant, negative impact on patients’ well-being, primarily due to distressing itch, sleep deprivation and social stigmatization due to visible lesions.

LEO Pharma acquired rights for tralokinumab in skin diseases in 2016 from AstraZeneca (LSE: AZN), in a deal that involved and upfront payment of $115 million to the Anglo-Swedish pharma major, as well up to $1 billion in commercially-related milestones and up to mid-teen tiered percentage royalties on product sales. AstraZeneca retains all rights to tralokinumab in respiratory disease and any other indications outside of dermatology.