Hoth Therapeutics Announces Positive, Statistically Significant Proof-of-Concept Preclinical Data on its Therapeutic for Cutaneous Lupus Erythematosus (CLE), a Chronic Autoimmune Skin Disease

Rhea-AI Summary

Hoth Therapeutics, Inc. (NASDAQ: HOTH) announced promising preclinical data for its therapy HT-005 targeting Cutaneous Lupus Erythematosus (CLE). Conducted by Jackson Laboratory with Zylö Therapeutics, results showed a significant reduction in skin plaque severity in mice after using HT-005-loaded topical Z-pods™. Improvements were observed within 3 weeks and maintained through 10 weeks. CEO Robb Knie expressed optimism about the therapeutic's potential addressing a high unmet need in CLE.

Positive

• Statistically significant reduction in skin plaque severity in CLE mouse model.
• Therapeutic response sustained over the 10-week treatment period.
• Positive proof-of-concept data boosts confidence in HT-005 therapy.

Negative

• None.

NEW YORK, Nov. 3, 2020 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company, today announced positive, statistically significant proof-of-concept preclinical data on its therapeutic HT-005 for the treatment of Cutaneous Lupus Erythematosus (CLE), a chronic autoimmune skin disease. 

The study conducted by Jackson Laboratory in partnership with Zylö Therapeutics using a CLE mouse model demonstrated a significant reduction in skin plaque severity after treatment with HT-005-loaded topical Z-pods™ compared to untreated control mice.  The skin severity scoring was based on a semi-quantitative measurement scale of erythema, thickness, scaling, and alopecia measured on the scapula, head, and overall composite score. The study was conducted over the period of 10 weeks and significant reduction of plaque severity in the overall composite score was observed within 3 weeks of treatment and maintained through the entire 10 week treatment cycle, supporting that the therapeutic response is sustained.

"Our final preclinical proof-of-concept data set provides us with optimism in our topical drug candidate for a high unmet need indication, CLE," stated, Robb Knie, Chairman and CEO of Hoth Therapeutics. "We look forward to working with our partner, Zylö Therapeutics, on the next phase of development of this promising therapeutic."

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 vaccine 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.

FAQ

What are the results of Hoth Therapeutics' recent study on HT-005?

The study demonstrated a significant reduction in skin plaque severity in a CLE mouse model after treatment with HT-005-loaded topical Z-pods™.

When was the positive preclinical data for HT-005 announced?

The positive preclinical data was announced on November 3, 2020.

What is the next step for Hoth Therapeutics after the preclinical results?

Hoth Therapeutics plans to continue working with Zylö Therapeutics on further development of the HT-005 therapeutic.

What does the study indicate about HT-005's effectiveness?

The study indicates that HT-005 effectively reduces skin plaque severity and provides a sustained therapeutic response.

What is Cutaneous Lupus Erythematosus and why is it significant?

Cutaneous Lupus Erythematosus (CLE) is a chronic autoimmune skin disease, and effective treatment options are limited, making Hoth's research significant.