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Hoth Therapeutics' Enrollment and Dosing in Second Cohort in Phase 1b Human Trial for Atopic Dermatitis Under Way

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Hoth Therapeutics (NASDAQ: HOTH) announced the initiation of enrollment and dosing for the second cohort in their Phase 1b clinical trial of BioLexa, targeting mild to moderate atopic dermatitis (eczema). This significant milestone is expected to enhance patient outcomes, with the second cohort consisting of current dermatitis patients. The trial is based in Australia, with ongoing patient enrollment. BioLexa aims to tackle chronic infections associated with Staphylococcal biofilms, leveraging a patented formulation to enhance treatment efficacy.

Positive
  • Enrollment and dosing for the second cohort in the BioLexa clinical trial has begun.
  • BioLexa is designed to treat mild to moderate atopic dermatitis.
  • The trial targets a significant unmet medical need in patients suffering from dermatitis.
Negative
  • None.

NEW YORK, Nov. 30, 2021 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company focused on developing new generation therapies for unmet medical needs, is pleased to announce that enrollment and dosing has begun for the second cohort in its First in Human clinical trial investigating topical BioLexa for the treatment of mild to moderate atopic dermatitis, also known as eczema.

"We are excited to have reached this pivotal milestone in our BioLexa development program to begin dosing adult patients," stated Stefanie Johns, Chief Scientific Officer of Hoth Therapeutics. "The second cohort is exclusively made up of current atopic dermatitis patients and we look forward to sharing top of the line data in 2022."

Hoth is conducting the BioLexa clinical trial in Australia. Patient enrollment continues for Phase 1. Anyone in Australia that is interested may review trial requirements at ClinicalTrials.Gov.

About BioLexa
BioLexa is a patented, proprietary antimicrobial topical formulation being developed for treatment of diseases mediated by Staphylococcal biofilms. Bacterial biofilms are specialized communities consisting of bacteria adhered to a surface (both biological and abiotic surfaces) and to other bacteria, and often with a protective extracellular matrix. Mature bacterial biofilms often result in chronic, recurrent infections that are difficult to treat due to the barrier effect of the biofilm that facilitates antibiotic resistance and avoiding immune system mechanisms. The BioLexa formulation is optimized to prevent Staphylococcal biofilm formation, keeping the bacteria in a more susceptible state to antimicrobial therapy. This novel mechanism of action has the potential to broadly treat clinical manifestations resulting from Staphylococcal biofilm formation.

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 indications including atopic dermatitis, skin toxicities associated with cancer therapy, chronic wounds, psoriasis, asthma, acne, and pneumonia. Hoth has also entered into two different agreements to further the development of two 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.

Contact
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 is the objective of Hoth Therapeutics' clinical trial for BioLexa?

The clinical trial aims to evaluate the safety and efficacy of BioLexa for treating mild to moderate atopic dermatitis.

When did Hoth Therapeutics begin the second cohort of their BioLexa trial?

Hoth Therapeutics began enrollment and dosing for the second cohort on November 30, 2021.

Where is the BioLexa clinical trial being conducted?

The BioLexa clinical trial is being conducted in Australia.

What is the significance of the BioLexa formulation?

BioLexa is designed to prevent Staphylococcal biofilm formation, potentially addressing chronic infections and antibiotic resistance.

What are the next steps for Hoth Therapeutics following this announcement?

Hoth Therapeutics plans to share top-line data from the trial in 2022.

Hoth Therapeutics, Inc.

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