Hoth Therapeutics to Initiate IND Enabling Studies of HT-001 Treatment for Cancer Patients

Rhea-AI Summary

On January 11, 2021, Hoth Therapeutics, Inc. (NASDAQ: HOTH) announced a partnership with Charles River Laboratories to conduct preclinical studies for HT-001, a topical treatment aimed at alleviating rash and skin disorders from EGFR inhibitor cancer therapies. Six preclinical studies are planned, beginning with bioanalytical method development in Q1 2021. The studies aim to fulfill FDA requirements for clinical trial initiation. Hoth's CEO emphasized the collaboration's importance in addressing significant unmet needs in dermatological care.

Positive

• Agreement with Charles River Laboratories to start preclinical studies for HT-001.
• HT-001 aims to address significant unmet needs for patients experiencing dermatological issues from EGFR inhibitor treatments.
• The studies are a crucial step toward initiating clinical trials, showing progress in Hoth's product development pipeline.

Negative

• None.

NEW YORK, Jan. 11, 2021 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company, today announced an agreement with Charles River Laboratories to initiate preclinical studies of HT-001, a topical formulation designed for the treatment of patients with rash and skin disorders associated with initial and repeat EGFR inhibitor cancer treatment.

Together with Charles River Laboratories, Hoth has outlined six preclinical studies, the first bioanalytical method development studies beginning in Q1 2021. The initial studies will develop the required bioanalytical methods to perform GLP toxicology studies required by the U.S. Food and Drug Administration (FDA) to initiate clinical studies for HT-001. Hoth recently submitted a request for a Pre-Investigational New Drug (IND) meeting to the FDA to discuss the proposed drug development program of HT-001 which is also anticipated to occur during the first quarter of 2021. At the Pre-IND Meeting, Hoth will discuss the required preclinical safety and toxicology studies and the full development plan of HT-001. After the Meeting, Hoth will then initiate the GLP toxicology studies with Charles River Laboratories.

"We are pleased to have reached an agreement to initiate our studies in collaboration with Charles River Laboratories," said Robb Knie, CEO of Hoth Therapeutics. "Charles River is the gold standard for toxicology studies in the industry. Execution of these critical preclinical studies takes us one step closer to the clinic. We believe our topical treatment addresses a significant unmet need as a supportive care treatment for the millions currently suffering from dermatological adverse effects of EGFR inhibitor cancer treatment."

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.

FAQ

What is the significance of Hoth Therapeutics' agreement with Charles River Laboratories?

The agreement marks the initiation of preclinical studies for HT-001, a treatment for skin disorders related to EGFR inhibitor cancer therapies.

What is HT-001 aimed to treat?

HT-001 is designed for patients suffering from rash and skin disorders associated with EGFR inhibitor cancer treatments.

When will Hoth Therapeutics begin its preclinical studies for HT-001?

The first bioanalytical method development studies are expected to begin in Q1 2021.

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

After the initial studies, Hoth plans to initiate GLP toxicology studies required by the FDA to start clinical trials.

What did Hoth Therapeutics request from the FDA for HT-001?

Hoth submitted a request for a Pre-Investigational New Drug (IND) meeting to discuss the drug development program for HT-001.