HOTH THERAPEUTICS REPORTS POSITIVE BIOLEXA PHASE 1B CLINICAL TRIAL RESULTS IN MILD TO MODERATE ATOPIC DERMATITIS

Rhea-AI Summary

Hoth Therapeutics has announced positive Phase 1b clinical trial results for BioLexa, aimed at treating mild-to-moderate atopic dermatitis. The trial demonstrated substantial improvements, with 100% of participants showing over 50% improvement as measured by the Eczema Area and Severity Index (EASI) over 28 days. Additionally, 60% of patients exhibited over 35% improvement using the SCORAD scale. BioLexa was well-tolerated without serious adverse events and improved quality of life for over half of participants.

Positive

• 100% of patients showed >50% improvement using EASI scale during the 28-day study.
• 60% of patients showed >35% improvement using SCORAD scale.
• 71% of patients had clinically relevant reduction in affected body surface area.
• BioLexa was well-tolerated with no serious treatment-emergent adverse events.

Negative

• None.

MEETS PRIMARY AND SECONDARY ENDPOINTS SAFETY AND EFFICACY

BIOLEXA led to significant improvement in disease severity as measured by SCORAD and EASI

Using the EASI scale, 100% of patients showed clinically relevant improvement >50% compared to Day 1 during the entire 28-day study treatment period

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 .

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 statements regarding compliance with the minimum bid price requirement and other applicable Nasdaq continued listing standards and the effect of the reverse stock split, including the estimated number of shares of common stock outstanding after effecting the reverse stock split; 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 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, 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 were the results of Hoth's BioLexa Phase 1b clinical trial?

The trial showed that 100% of patients had over 50% improvement using the EASI scale, with 60% showing over 35% improvement via the SCORAD scale.

When was Hoth Therapeutics' BioLexa Phase 1b trial results announced?

The results were announced on October 31, 2022.

What is the significance of the BioLexa trial results for Hoth Therapeutics?

The positive results from the trial support the potential of BioLexa as a safe and effective treatment option for patients with atopic dermatitis.

Are there any safety concerns with BioLexa from the trial data?

BioLexa was well-tolerated, with no serious adverse events reported during the trial.