Hoth Therapeutics Announces Preliminary Efficacy Findings From Phase 1b Clinical Trial with Mild to Moderate Atopic Dermatitis Patient Cohort

Rhea-AI Summary

Hoth Therapeutics, Inc. (NASDAQ: HOTH) announced preliminary findings from its Phase 1b clinical trial of BioLexa Lotion for mild to moderate atopic dermatitis. Conducted in Australia, the study showed some patients experienced improvement in symptoms across three efficacy endpoints: Eczema Area and Severity Index (EASI), SCORing Atopic Dermatitis (SCORAD), and Investigator Global Assessment (IGA). No adverse events were reported during the dosing period. Full study results will be released later.

Positive

• Preliminary findings indicate improvement in atopic dermatitis symptoms across three efficacy endpoints.
• No adverse events reported during the BioLexa dosing period.

Negative

• None.

The preliminary findings reported include patients that showed improvement in atopic dermatitis symptoms and severity across three efficacy endpoints

NEW YORK, May 3, 2022 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, today announced the preliminary findings from Hoth's randomized, double-blind, placebo-controlled Phase 1b study investigating the safety and efficacy of BioLexa Lotion in patients with mild to moderate atopic dermatitis. The study is being conducted at multiple sites in Australia by the contract research organization Novotech. Currently, Novotech has reported no adverse events from those that have completed the BioLexa dosing period.

The company reported findings from three efficacy secondary endpoints from the trial: the Eczema Area and Severity Index (EASI), the SCORing Atopic Dermatitis scale (SCORAD), and an Investigator Global Assessment scale (IGA). The study is randomized to 3 blinded treatments at a ratio of 40% BioLexa:40% Active Control Lotion:20% Placebo Lotion. Of the patients that have completed the dosing period with the blinded, investigative product, some patients have shown improvement across the EASI, SCORAD, and IGA; this improvement in AD symptoms and severity was also observed at the 1-week follow-up visit. Some patients were considered "almost clear" at the end of the dosing period and "clear" or "almost clear" at the 1-week follow-up based on the IGA score.

The full study results remain blinded and will be shared at a later date, as they become available.

About Hoth Therapeutics, Inc.

Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing new generation therapies for unmet medical needs. Hoth's pipeline development is focused to improve the quality of life for patients suffering from skin toxicities associated with cancer therapy, mast-cell derived cancers and anaphylaxis, Alzheimer's Disease, atopic dermatitis and other indications. To learn more, please visit https://ir.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 Hoth may develop, and the labeling under any approval Hoth may obtain; the timing and costs of clinical trials; the timing and costs of other expenses; market acceptance of Hoth's products; the ultimate impact of the current Coronavirus pandemic, or any other health epidemic, on Hoth's business, its clinical trials, its research programs, healthcare systems or the global economy as a whole; Hoth's intellectual property; Hoth's reliance on third party organizations; Hoth's competitive position; Hoth's industry environment; Hoth's anticipated financial and operating results, including anticipated sources of revenues; Hoth's assumptions regarding the size of the available market, benefits of Hoth's products, product pricing and timing of product launches; management's expectation with respect to future acquisitions; statements regarding Hoth's goals, intentions, plans and expectations, including the introduction of new products and markets; and Hoth's 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 undue 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 Hoth believes that the expectations reflected in the forward-looking statements are reasonable, Hoth 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 of this press release. Consequently, forward-looking statements should be regarded solely as Hoth's current plans, estimates, and beliefs. Hoth cannot guarantee future results, events, levels of activity, performance or achievements. Hoth does not undertake and specifically declines any obligation to update 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.

FAQ

What are the preliminary findings from Hoth Therapeutics' clinical trial for atopic dermatitis?

The preliminary findings indicate that some patients showed improvement in atopic dermatitis symptoms across three efficacy endpoints: EASI, SCORAD, and IGA.

Where is Hoth Therapeutics conducting its Phase 1b clinical trial?

The Phase 1b clinical trial is being conducted at multiple sites in Australia.

What safety results were reported in the BioLexa Lotion trial?

The contract research organization Novotech reported no adverse events from patients who completed the BioLexa dosing period.

When will the full results of the clinical trial for BioLexa Lotion be available?

The full study results remain blinded and will be shared at a later date as they become available.

What is the significance of the efficacy endpoints EASI, SCORAD, and IGA?

EASI, SCORAD, and IGA are established scales used to assess the severity of atopic dermatitis symptoms.