Denmark’s Union Therapeutics A/S has begun a strategic collaboration with Innovent Biologics Inc. over orismilast, a next-generation oral PDE4 inhibitor for inflammatory dermatology conditions that could compete directly with Amgen Inc.’s psoriasis blockbuster, Otezla (apremilast). At the same time, the company is looking for partners in the medium term to develop the drug in the rest of the world as it bids to take on Amgen and other dermatology players such as Bristol-Myers Squibb Co.
What one analyst characterized as “a little bit of an exotic or at least unusual statistical analysis on the phase II primary endpoint” may have dampened enthusiasm somewhat for Evelo Biosciences Inc.’s results in mild and moderate psoriasis with EDP-1815, but the firm is advancing the compound to registration studies.
Sanofi SA’s high-profile phase III blow-up Sept. 9 with the oral BTK inhibitor rilzabrutinib in pemphigus brought fresh attention to the group of rare diseases – which cause blisters on the skin and mucous membranes throughout the body – and to players pushing for a new treatment.
Shares of Forte Biosciences Inc. (NASDAQ:FBRX) touched a 52-week low, diving 82.3% to close at $5.06 on Sept. 3 after its sole candidate, FB-401, failed to make a statistically significant difference in improving the severity of atopic dermatitis. The result, contrasting starkly with a smaller positive trial, led CEO Paul Wagner to announce the company would quit development of the FDA fast-tracked asset, licensed from the U.S. National Institute of Allergy and Infectious Diseases.
The FDA has approved Korsuva (difelikefalin) from Cara Therapeutics Inc. for pruritis in patients undergoing hemodialysis, following a fast review. Korsuva is the first therapy approved by the FDA in the indication and is the first ever approval for the Stamford, Conn.-based company.
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.
Riding high on dramatic phase Ib results with KIT receptor-binding monoclonal antibody CDX-0159 in urticaria (hives), Celldex Therapeutics Inc. plans to begin phase II work in the first half of next year. Shares of Hampton, N.J.-based Celldex (NASDAQ:CLDX) closed July 12 at $40.67, up $8.26, or 25%, as Wall Street reacted to favorable data from the trial in antihistamine-refractory cold urticaria and symptomatic dermographism, the two most common forms of chronic inducible urticaria (CindU).
A not-unexpected complete response letter (CRL) for Nexobrid, being developed by Mediwound Ltd., delayed the therapy’s approval and knocked the company’s share values backward. Nexobrid, proteolytic enzymes enriched in bromelain for treating for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns, had a June 29 PDUFA date.
More than four months after its original PDUFA date of Feb. 2, 2021, Mallinckrodt plc’s Stratagraft gained FDA approval for use in deep partial-thickness thermal burns.
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