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.
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