Hoth Therapeutics Gets Greenlight to Start Phase 1b Trial of BioLexa for AD in Australia

The 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 AD in the second quarter. 

Hoth Therapeutics, Inc. received Human Research Ethics Committee clearance to commence the first cohort of the Phase 1b clinical trial of BioLexa Lotion for the treatment of mild-to-moderate atopic dermatitis (AD) in Australia. 

BioLexa is a patented, proprietary antimicrobial topical formulation being developed for treatment of diseases mediated by Staphylococcal biofilms including AD.

The 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 AD 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 AD. 

"Receiving ethical clearance is a critical milestone towards initiating our Phase 1b clinical trial in Australia," says Robb Knie, Chairman and CEO of Hoth Therapeutics, in a news release. "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 AD solution, BioLexa, represents a significant global opportunity and we look forward to advancing the treatment through the clinic."

BioLexa Phase 1b Trial Design:

• Randomized, 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 AD. 
• 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 AD patient cohort, including change in AD extent of involvement and severity using EASI, SCORAD, IGA as well as patient-centric quality of life assessments.