Hoth Therapeutics Announces Successful Completion of Pre-IND Meeting with FDA Regarding Proposed Development of HT-001 For Cancer Patients
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Hoth intends to pursue FDA Expedited Programs, such as Breakthrough Designation, pending generation of future clinical study data for HT-001
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NEW YORK, Feb. 23, 2021 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company, today announced today the successful completion of a pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding the Company's development plan for their HT-001 product. The Pre-IND meeting was completed through written responses provided by the FDA Division of Dermatology and Dentistry on February 22, 2021.
HT-001 is a topical formulation under development for the treatment of rash and skin disorders associated with initial and repeat courses of tyrosine kinase inhibitor/epidermal growth factor receptor (EGFR) inhibitor therapy. HT-001 is being developed for New Drug Application (NDA) submission via the 505(b)(2) regulatory pathway.
Based on the FDA's feedback, Hoth intends to advance its IND-enabling activities for HT-001 as planned. Key feedback from FDA provided as part of the Pre-IND written responses included:
- The proposed HT-001 formulation and drug substance specifications are reasonable.
- No significant changes to the planned IND-enabling toxicology program for the planned phase 2a study
- The proposed indication for HT-001 across the entire class of EGFR inhibitors may be appropriate, pending appropriate data from phase 3 trials.
- Signs and symptoms related to EGFR inhibitor therapy could qualify as a "serious condition" that could enable future application for programs under the FDA guidance, Expedited Programs for Serious Conditions such as Breakthrough Designation; this is also pending the development of preliminary clinical evidence to support such applications.
- Detailed feedback regarding the design and assessments in the proposed IND-opening phase 2a study in patients receiving EGFR inhibitor therapy.
"We are very pleased with the outcome of the pre-IND meeting written responses from the FDA," said Robb Knie, CEO of Hoth Therapeutics. "The positive feedback from the FDA is a significant milestone for Hoth in executing our clinical development program for HT-001 in treating cancer patients suffering from dermatological ailments during EGFR inhibitor treatment."
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.
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.
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SOURCE Hoth Therapeutics, Inc.
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