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Upadacitinib Clears Atopic Dermatitis Faster Than Dupilumab
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Tirbanibulin Ointment Clears Actinic Keratosis Lesions in Half of Recipients Within 2 Months
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Almirall announces New England Journal of Medicine publication of Phase III data demonstrating efficacy and safety of Klisyri® (tirbanibulin)
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®
(tirbanibulin) is a novel microtubule inhibitor, recently approved by the U.S. Food and Drug Administration (FDA) for the topical treatment of actinic keratosis (AK) of the face or scalp and is under evaluation by the European Medicines Agency (EMA)
-
®
(tirbanibulin)
demonstrated complete clearance of AK lesions at day 57 in treated face or scalp areas in a significantly higher number of patients than with vehicle
[i]
Klisyri
® has a demonstrated safety profile with no patient withdrawals from the Phase III studies due to adverse events, and a once daily 5-day self-application period
Specifically, 44% (77 of 175) of patients on tirbanibulin in the first trial which include 351 patients total achieved complete clearance of actinic keratoses at day 57 versus only 5% (eight of 176) of those on the vehicle ointment (difference 40 percentage points, 95% CI 32-47,
P 0.001).
And in the second trial, which also included a total of 351 patients, 54% (97 of 178 patients) of those on tirbanibulin achieved complete lesion clearance versus only 13% (22 of 173) of the placebo group (difference 42 percentage points, 95% CI 33-51,
P 0.001).
Significantly more patients also achieved partial reduction in the number of lesions, defined as up to 75% reduction. This occurred in 68% and 76% of patients in the tirbanibulin groups in the first and second trials, respectively.
Evelo Biosciences, Inc.: Evelo Biosciences Reports New Positive Confirmatory Data from Phase 1b Trial of EDP1815 in Atopic Dermatitis physician-reported outcomes -
-Improvements in patient-reported outcomes in DLQI and POEM, including itch-
-EASI50 benchmark reached in 44% of patients treated with EDP1815 compared to 0% in placebo group at day 70-
-Phase 2 atopic dermatitis trial initiation in 3Q 2021-
-Management to host conference call at 8:30 a.m. ET today with Dr. Benjamin Ehst-
CAMBRIDGE, Mass., Jan. 20, 2021interim data in 23 evaluable patients. These new results now include patient-reported outcomes, as well as all of the physician-reported outcomes for all 24 patients in the cohort. The primary endpoint of the Phase 1b trial was safety and tolerability. EDP1815 was well tolerated in this study with no treatment-related adverse events of moderate or severe intensity, and no serious adverse events.
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