A few months after disclosing its merger with Chiasma Inc., Amryt plc rolled out second quarter financials pleasing to Wall Street, where considerable interest has begun to manifest in the company’s epidermolysis bullosa program with Filsuvez, also known as Oleogel-S10.
With its topical gel for primary axillary hyperhidrosis (excessive underarm sweating) in adults and children 9 years of age and older, Brickell Biotech Inc. is gearing up to challenge Journey Medical Corp.’s Qbrexza (glycopyrronium), an anticholinergic agent contained in a single-use, pre-moistened, medicated cloth.
New and updated preclinical and clinical data presented by biopharma firms at the European Academy of Dermatology and Venereology Congress, including: Abbvie, Arcutis, BMS, Dermavant, Eli Lilly, Leo, Novartis, Rapt, Sanofi.
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.