Hoth's Steroid-sparing AD Treatment Shows Promise in Phase 1b Trial

09/06/2023

BioLexa led to a 35% improvement in SCORAD measurement and a 60% improvement in EASI measurement during a 14-day treatment period, according nalysis of the Phase 1b clinical trial data from Hoth Therapeutics.

BioLexa led to a 35% improvement in SCORAD ("SCORing Atopic Dermatitis") measurement and a 60% improvement in EASI (Eczema Area and Severity Index) measurement of atopic skin disease during a 14-day treatment period, whereas gentamicin lotion and placebo had no effect, according to an analysis of the Phase 1b clinical trial data from Hoth Therapeutics.

BioLexa is a patented, proprietary antimicrobial topical formulation being developed for treatment of diseases mediated by Staphylococcal biofilms. The BioLexa formulation is optimized to prevent Staphylococcal biofilm formation, keeping the bacteria in a more susceptible state to antimicrobial therapy. 

For the study, patients were randomized into three blinded treatments of the BioLexa lotion, gentamicin lotion, or placebo for a 14-day treatment period. Patients eligible to be enrolled in this trial had mild to moderate atopic disease.

Patient-reported DLQI (Dermatology Life Quality Index questionnaire) found that BioLexa use led to a 46% improvement in patient quality of life, whereas gentamicin lotion and placebo had no effect.

When asked about their general impression of care since starting the study, 78% of patients reported that their overall health had improved since starting BioLexa, as compared to 22% stating that there was no change in their health, or their health was worse. Of the 78% of patients that reported an improvement in health, 42% of them said that their health was "much improved" or "very much improved". 

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