Johnson & Johnson is adding to its dermatology portfolio with the $850 million purchase of privately held Proteologix Inc. The Redwood City, Calif.-based company brings with it two bispecific antibodies into a space dominated by the blockbuster injectable Dupixent (dupilumab). Proteologix has PX-128, which targets IL-13 plus thymic stromal lymphopoietin for treating moderate to severe atopic dermatitis and moderate to severe asthma, and PX-130, which also targets IL-13 plus IL-22, for treating moderate to severe AD. Both are in preclinical development, but Johnson & Johnson said PX-128 is ready for its phase I close-up.
Apogee Therapeutics Inc.’s phase I home run put IL-13-targeting antibody APG-777 on an accelerated development path in atopic dermatitis, and the company touted its similarity to further-along IL-13 competitor lebrikizumab, from Eli Lilly and Co., as a likely indicator of further success.
Partners Regeneron Pharmaceuticals Inc. and Sanofi SA will file a supplemental BLA by year-end for Dupixent (dupilumab) in chronic obstructive pulmonary disease (COPD) after interim data from a second phase III trial confirmed – even bested – data from the first, demonstrating a reduction in exacerbations by 34% and improved lung function in patients with uncontrolled COPD and evidence of type 2 inflammation.
Apogee Therapeutics Inc. recently presented preclinical data on its lead candidate, APG-777, a fully optimized and half-life extended antibody targeting IL-13 for the treatment of atopic dermatitis and asthma.
Privately held Leo Pharma Inc. has worked its way through a complete response letter issued in April to see the FDA approve Adbry (tralokinumab-ldrm) for treating moderate to severe atopic dermatitis in adults. The CRL noted FDA requests for additional data related to the device component, a prefilled syringe of tralokinumab, but it did not request new efficacy or safety data related to the drug product formulation. In April and on Dec. 28, the company did not provide details on the device-related data that were requested.
Eli Lilly and Co.’s $1.1 billion acquisition of Dermira Inc. early last year is looking like a smart move after the company’s atopic dermatitis (AD) drug, lebrikizumab, hit all its targets in two phase III trials. Lebrikizumab is an interleukin-13 antagonist and is part of Lilly’s strategy to build a dermatology portfolio to compete in a market dominated by Sanofi SA and Regeneron Pharmaceutical Inc.’s Dupixent (dupilumab), which was the first injected antibody drug available for AD in 2017. Lilly picked up Dermira, of Menlo Park, Calif., along with lebrikizumab in January last year shortly after the FDA granted lebrikizumab fast track status, paving the way for a potential six-month review.
The FDA slapped Leo Pharma A/S’ BLA for IL-13 inhibitor tralokinumab with a complete response letter (CRL), making it the latest atopic dermatitis candidate to hit a regulatory setback in the U.S., following delays for three oral JAK inhibitor drugs earlier this month.
