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Hoth Therapeutics Receives Approval to Commence Cohort 2 in Clinical Trial of BioLexa for the Treatment of Atopic Dermatitis Patients
NEW YORK, Oct. 12, 2021 /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, Oct. 12, 2021 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company, today announced that is has received Human Research Ethics Committee (HREC) clearance to commence cohort 2 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 \nBioLexa Trial Design:\nRandomized, double-blind, parallel-design, placebo-controlled study. Cohort 2 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 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 clearance for Cohort 2 is the next critical milestone in the Phase 1b clinical trial in Australia. Hoth's scientific advisors believe that Hoth's atopic dermatitis solution, BioLexa, represents a significant global opportunity and looks forward to advancing the treatment through the clinic.\nThe Company expects to start screening and enrolling the first subject(s) of Cohort 2 in October.\nAbout BioLexaBioLexa is a patented, proprietary antimicrobial topical formulation being developed for treatment of diseases mediated by Staphylococcal biofilms. Bacterial biofilms are specialized communities consisting of bacteria adhered to a surface (both biological and abiotic surfaces) and to other bacteria, and often with a protective extracellular matrix. Mature bacterial biofilms often result in chronic, recurrent infections that are difficult to treat due to the barrier effect of the biofilm that facilitates antibiotic resistance and avoiding immune system mechanisms. The BioLexa formulation is optimized to prevent Staphylococcal biofilm formation, keeping the bacteria in a more susceptible state to antimicrobial therapy. This novel mechanism of action has the potential to broadly treat clinical manifestations resulting from Staphylococcal biofilm formation.\nAbout Hoth Therapeutics, Inc.Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused o...