HONG KONG – Final results of Takeda Pharmaceutical Co. Ltd.’s phase III open-label extension study of Takhzyro (lanadelumab) showed that continued treatment with the monoclonal antibody may help with the long-term prevention of hereditary angioedema attacks as well as reducing their frequency.
Arena Pharmaceuticals Inc. CEO Amit Munshi said “a cluster of patients in a single clinical site” skewed results of the phase IIb study testing etrasimod in atopic dermatitis (AD), and caused the selective S1P modulator to miss its primary endpoint.
Bristol Myers Squibb Co. reported that its first-in-class oral selective kinase 2 inhibitor, deucravacitinib (formerly BMS-986165), beat out Otezla (apremilast) in a head-to-head phase III trial in psoriasis.
With avacopan’s PDUFA date in anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA vasculitis) set for next summer, Chemocentryx Inc. rolled out long-awaited, COVID-19-delayed top-line findings from the company’s phase II, 390-patient Aurora study testing the compound for hidradenitis suppurativa (HS).
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.
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