HOTH THERAPEUTICS REPORTS POSITIVE BIOLEXA PHASE 1B CLINICAL TRIAL RESULTS IN MILD TO MODERATE ATOPIC DERMATITIS
01 Nov 2022
AcquisitionCollaborateClinical ResultPhase 1
NEW YORK, Oct. 31, 2022 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, today announced positive data for BioLexa, its investigational therapeutic in a Phase 1b clinical trial in adult patients with mild-to-moderate atopic dermatitis.
Using the SCORAD ("SCORing Atopic Dermatitis") as a clinical tool for assessing the severity (i.e., extent, intensity) of atopic dermatitis and EASI score, which is a tool used to measure the extent (area) and severity of atopic eczema (Eczema Area and Severity Index) all patients showed improvement during the study compared to the day one score. Using the EASI scale, 100% of patients showed clinically-relevant improvement >50% compared to Day 1 during the entire 28 day study treatment period. Using SCORAD 60% of patients showed overall clinically relevant improvement by SCORAD (>35% improvement) during the study compared to the Day 1 score. 42% of patients maintained improvement from day 14 to day 28 (which includes 2 weeks without active treatment). This supports the long-term effect of BioLexa based on the mechanism of action to treat the underlying staphylococcal infection.
A clinically relevant reduction in the total body surface area affected by atopic dermatitis was observed in 71% patients treated with BioLexa; within these patients, the total reduction ranged from 37.5% - 71.4%.
BioLexa was well tolerated with no serious adverse events and no drug-related treatment-emergent adverse events observed, according to the safety results. In addition, >50% of patients reported an improvement in the effect of atopic dermatitis on their quality of life.
Robb Knie, Chief Executive Officer of Hoth Therapeutics, stated, "Today's positive results give us even more confidence that BioLexa can help provide relief from atopic dermatitis in patients, without the harmful long-term effects of corticosteroids and other side effects that many patients suffer with today's choice of approved therapeutics."
"I am impressed by these early clinical results showing the efficacy of Biolexa for the treatment of atopic dermatitis. The overall satisfaction of patients while on BioLexa and during follow-up makes me excited for future clinical studies", stated Dr. Jonathan Zippin, Associate Professor of Dermatology and Pharmacology at Weill Medical College of Cornell, Director of Dermatology Precision Medicine, and Vice Chair of Research for the Department of Dermatology. Zippin is a member of Hoth Therapeutics Scientific Advisory Board.
"Atopic dermatitis being a complex inflammatory skin disease, we need therapeutic approaches that address the wide array of disease drivers. Biolexa takes an innovative and unique approach and I am looking forward to seeing how this clinical program unfolds," stated Adam Friedman, MD, FAAD Professor and Chair of Dermatology GW School of Medicine and Health Sciences and member of Hoth's Scientific Advisory Board.
The company reported findings from efficacy secondary endpoints from the trial: the Eczema Area and Severity Index (EASI), the SCORing Atopic Dermatitis scale (SCORAD), The study is randomized to 3 blinded treatments at a ratio of 40% BioLexa:40% Active Control Lotion:20% Placebo Lotion.
About Hoth Therapeutics, Inc.
Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to developing innovative, impactful, and ground-breaking treatments with a goal to improve patient quality of life. We are a catalyst in early-stage pharmaceutical research and development, elevating drugs from the bench to pre-clinical and clinical testing. Utilizing a patient-centric approach, we collaborate and partner with a team of scientists, clinicians, and key opinion leaders to seek out and investigate therapeutics that hold immense potential to create breakthroughs and diversify treatment options. To learn more, please visit https://hoththerapeutics.com .
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