New articles highlighting phase III data on the IL-13 inhibitor tralokinumab from Leo Pharma A/S have shown that combining it with topical corticosteroids as needed was effective and well-tolerated in patients with moderate to severe atopic dermatitis.
Amytrx Therapeutics Inc., of Nashville, Tenn., founded in 2014 but coming out of stealth now, is developing a therapeutic for treating multiple inflammatory, autoimmune and metabolic diseases.
DUBLIN – Shares in Amryt Pharma plc surged by more than 36% Sept. 9 on news that Filsuvez (AP-101, Oleogel-S10) attained the primary endpoint of a phase III trial in epidermolysis bullosa.
With the FDA approval of Cassiopea SpA’s Winlevi (clascoterone cream 1%) to treat acne in patients 12 years and older, the European company hailed it as the first acne drug in 40 years with a new mechanism of action.
Like many companies, New York-based Abeona Therapeutics Inc. faltered clinically as a result of the COVID-19 virus, which delayed enrollment in the phase III study with EB-101 gene therapy in recessive dystrophic epidermolysis bullosa (RDEB), but the company earlier this month disclosed the restart of patient enrollment in the experiment called Viital.
All the primary and secondary efficacy endpoints were met in Boulder, Colo.-based Brickell Biotech Inc.’s pivotal phase III study of the anticholinergic sofpironium bromide in treating primary axillary hyperhidrosis, which involves excessive sweating in the armpits that interferes with daily life and work.
HONG KONG – Takeda Pharmaceutical Co. Ltd. is preparing to take Takhzyro (lanadelumab) to the world stage after announcing its interim results for a phase III hereditary angioedema long-term prophylaxis (HELP) study.
Leo Pharma A/S, of Ballerup, Denmark, has eyed a stronger company presence in Asia during the past year and took a giant step to achieving it by signing a worldwide exclusive licensing agreement with Oneness Biotech Co. Ltd., of Taipei, Taiwan, and Microbio Shanghai Co. Ltd. to develop and commercialize FB-825 for treating atopic dermatitis and allergic asthma.
Menlo Therapeutics Inc. announced a double dose of bad news with negative results for two phase III trials testing its NK1 receptor antagonist, serlopitant, as a treatment for pruritus (itch) associated with prurigo nodularis, a skin disease characterized by hard, itchy nodules.
Castle Creek Biosciences Inc. CEO John Maslowski told BioWorld the firm’s $75 million financing will propel phase III research with FCX-007 in recessive dystrophic epidermolysis bullosa (RDEB), with top-line data due in the first quarter of 2021 – “a big inflection point” for the Exton, Pa.-based company, which plans a BLA filing for that year as well.
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