Hoth Therapeutics Receives Approval to Commence Phase 1b Clinical Trial of BioLexa for the Treatment of Atopic Dermatitis in Humans
Hoth Therapeutics (NASDAQ: HOTH) has secured Human Research Ethics Committee (HREC) clearance to initiate its Phase 1b clinical trial of BioLexa Lotion for treating mild to moderate atopic dermatitis in Australia. Dosing of the first subject is expected early 2021, with top-line data anticipated in Q1 2021. The trial aims to evaluate the safety and pharmacokinetics of BioLexa, with preliminary efficacy assessed in a second patient cohort. CEO Robb Knie emphasized the milestone as crucial for submitting data for future FDA considerations.
- Received HREC clearance to start Phase 1b clinical trial for BioLexa Lotion.
- First subject dosing expected in early 2021.
- Top-line data to be reported by Q1 2021, advancing toward Phase 2 trial.
- None.
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.
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 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.
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 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."
About Hoth Therapeutics, Inc.
Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing new generation therapies for dermatological disorders. Hoth's pipeline has the potential to improve the quality of life for patients suffering from indications including atopic dermatitis, chronic wounds, psoriasis, asthma and acne. Hoth has also recently entered into two different agreements to further the development of two different therapeutic prospects to prevent or treat COVID-19. To learn more, please visit www.hoththerapeutics.com.
Forward-Looking Statement
This press release includes forward-looking statements based upon Hoth's current expectations which may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws, and are subject to substantial risks, uncertainties and assumptions. These statements concern Hoth's business strategies; the timing of regulatory submissions; the ability to obtain and maintain regulatory approval of existing product candidates and any other product candidates we may develop, and the labeling under any approval we may obtain; the timing and costs of clinical trials, the timing and costs of other expenses; market acceptance of our products; the ultimate impact of the current Coronavirus pandemic, or any other health epidemic, on our business, our clinical trials, our research programs, healthcare systems or the global economy as a whole; our intellectual property; our reliance on third party organizations; our competitive position; our industry environment; our anticipated financial and operating results, including anticipated sources of revenues; our assumptions regarding the size of the available market, benefits of our products, product pricing, timing of product launches; management's expectation with respect to future acquisitions; statements regarding our goals, intentions, plans and expectations, including the introduction of new products and markets; and our cash needs and financing plans. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. You should not place reliance on these forward-looking statements, which include words such as "could," "believe," "anticipate," "intend," "estimate," "expect," "may," "continue," "predict," "potential," "project" or similar terms, variations of such terms or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described in the section entitled "Risk Factors" in Hoth's most recent Annual Report on Form 10-K and Hoth's other filings made with the U. S. Securities and Exchange Commission. All such statements speak only as of the date made. Consequently, forward-looking statements should be regarded solely as Hoth's current plans, estimates, and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance or achievements. Hoth does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law.
Investor Contact:
LR Advisors LLC
Email: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com
Phone: (678) 570-6791
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SOURCE Hoth Therapeutics, Inc.
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