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Hoth Therapeutics Receives Approval to Commence Phase 1b Clinical Trial of BioLexa for the Treatment of Atopic Dermatitis in Humans
NEW YORK, Dec. 10, 2020 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company, today announced that is has received Human
About this update from Hoth Therapeutics, Inc.
[{"type":"text","content":"NEW YORK, Dec. 10, 2020 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company, today announced that is has received Human Research Ethics Committee (HREC) clearance to commence the first cohort of the Phase 1b clinical trial of BioLexa Lotion for the treatment of mild to moderate atopic dermatitis in Australia. \n\n \n \n \n \n \n \n\n \nThe Company expects to dose the first subject during early 2021 and report top-line data from the first cohort of the trial in the first quarter of 2021, followed by initiation of dosing in patients with mild to moderate atopic dermatitis in the second quarter. Following the successful completion of the Phase 1b trial, the Company intends to conduct a Phase 2 trial with adult and adolescent patients to continue clinical investigation of the efficacy of BioLexa Lotion for treatment of mild to moderate atopic dermatitis. \nBioLexa Phase 1b Trial Design:\nRandomized, double-blind, parallel-design, placebo-controlled study conducted in two parts. Part 1 will be conducted in healthy subjects. After review of the Part 1 safety data, the study will proceed with Part 2 that includes adult patients with mild to moderate atopic dermatitis. The primary goal of the study is to evaluate the safety and characterize pharmacokinetics of topical BioLexa Lotion. Participants will be treated twice daily with topical application directly on skin for 14 days Preliminary efficacy will also be investigated in the Part 2 atopic dermatitis patient cohort, including change in atopic dermatitis extent of involvement and severity using EASI, SCORAD, IGA as well as patient-centric quality of life assessments.\"Receiving ethical clearance is a critical milestone towards initiating our Phase 1b clinical trial in Australia,\" stated Robb Knie, Chairman and CEO of Hoth Therapeutics. \"Beyond the cost efficiencies of conducting a trial in Australia, we strategically chose Australia for our Phase 1b trial due to the rigorous guidelines of the HREC, which will support the submission of our full data set upon successful completion of this Phase 1b and our upcoming Phase 2 trial to the FDA. Management, our Board and scientific advisors believe that Hoth's atopic dermatitis solution, BioLexa, represents a significant global opportunity and we look forward to advancing the treatment through the clinic.\"\...