As more therapies are approved to treat severe atopic dermatitis, U.S. payers should make available at least one biologic and one JAK1 inhibitor, given how different the drug classes are in their onset of action and their risk profile, a panel of experts recommended at a recent Institute for Clinical and Economic Review (ICER) roundtable.
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.
Rapt Therapeutics Inc. CEO Brian Wong said RPT-193 monotherapy in atopic dermatitis (AD) “looks really promising, but there’s still quite a bit to learn” about the small molecule, designed to inhibit the migration of Th2 cells into inflamed tissues by blocking CCR4. Investors saw enough to push the shares of South San Francisco-based Rapt up 115.5%, or $21.45, to close at $40.02, after trading as high as $41.99 during the day.
Kyowa Kirin Co. Ltd. has partnered with Amgen Inc. to jointly develop and commercialize KHK-4083, Kyowa Kirin’s phase III-ready anti-OX40 fully human monoclonal antibody for the potential treatment of atopic dermatitis. Kyowa Kirin will receive a $400 million up front, while milestone payments could add an additional $850 million. Significant royalty payments on future global sales could sweeten the blockbuster deal.
Kyowa Kirin Co. Ltd. has partnered with Amgen Inc. to jointly develop and commercialize KHK-4083, Kyowa Kirin’s phase III-ready anti-OX40 fully human monoclonal antibody for the potential treatment of atopic dermatitis. Kyowa Kirin will receive a $400 million up front, while milestone payments could add an additional $850 million. Significant royalty payments on future global sales could sweeten the blockbuster deal.
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.
Despite stock-denting phase II data with the oral version of Korsuva (difelikefalin) for moderate to severe pruritis in patients with moderate to severe atopic dermatitis (AD), Cara Therapeutics Inc. CEO Derek Chalmers said the outcome “prioritizes moving forward. We got what we needed from the phase II trial,” which identified the patients most sensitive to the drug, nailed down a dose spectrum, and equipped the company to power a registrational effort, he said.
The Human Skin Cell Atlas, comprising transcriptomes of 528,253 single cells, shows that cellular processes involved in skin development in embryos are reactivated in inflammatory skin diseases. In addition to suggesting potential new drug targets for atopic dermatitis and psoriasis, the transcriptomes provide a new route to understanding other inflammatory diseases, and provide a template for culturing skin for wound repair, according to the authors of a paper published in the Jan. 22, 2021, issue of Science.
The Human Skin Cell Atlas, comprising transcriptomes of 528,253 single cells, shows that cellular processes involved in skin development in embryos are reactivated in inflammatory skin diseases. In addition to suggesting potential new drug targets for atopic dermatitis and psoriasis, the transcriptomes provide a new route to understanding other inflammatory diseases.
DUBLIN – Sanofi SA is paying $1.1 billion up front and up to $350 million more in potential clinical development and regulatory milestones to acquire antibody developer Kymab Ltd. The deal adds to Sanofi’s pipeline first-in-class OX40-ligand blocker KY-1005, which recently hit the primary endpoints of a phase IIa trial in atopic dermatitis, as well as a second clinical-stage asset, KY-1044, an ICOS agonist in development for solid tumors. It also brings Sanofi a new antibody discovery platform, comprising several transgenic mouse strains, which collectively encode all the building blocks required to produce fully human antibodies.
