Hoth Therapeutics Submits Request for a Pre-Investigational New Drug (Pre-IND) Meeting for HT-001, Treatment for Cancer Patients

Rhea-AI Summary

Hoth Therapeutics, Inc. (NASDAQ: HOTH) has requested a Pre-Investigational New Drug (IND) meeting with the FDA regarding HT-001, a topical treatment aimed at addressing skin disorders from epidermal growth factor receptor (EGFR) inhibitor therapy. Over 50% of cancer patients on EGFR inhibitors experience dermatological side effects, impacting their treatment. HT-001 seeks to improve these patients' quality of life. Currently in preclinical development, the company plans to discuss clinical trial designs in its upcoming FDA meeting scheduled for Q1 2021.

Positive

• HT-001 targets a significant unmet medical need for cancer patients on EGFR inhibitors with no current approved treatments.
• The company is advancing its drug development process with an FDA meeting planned for Q1 2021.

Negative

• HT-001 is still in the preclinical stage, indicating that the drug is not yet available to patients.
• There is no guarantee of approval from the FDA following the Pre-IND meeting.

NEW YORK, Dec. 23, 2020 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company, today announced the request for a Pre-Investigational New Drug (IND) meeting to the U.S. Food and Drug Administration (FDA) to discuss the proposed drug development program for HT-001, a topical drug formation under development for the treatment of rash and skin disorders associated with epidermal growth factor receptor (EGFR) inhibitor therapy. EGFR inhibitors are critical therapeutic agents for the treatment of non-small cell lung cancer (NSCLC), pancreatic cancer, colorectal cancer, squamous-cell carcinoma of the head and neck, and breast cancer.

Cancer patients receiving EGFR inhibitor therapy often require repeat courses to achieve effective cancer treatment, and >50% of patients have significant dermatological side effects within the first 2 weeks of treatment that persist even after stopping EGFR therapy. These skin toxicities can severely impact patient quality of life and can result in reduction of EGFR inhibitor dose or interruption of treatment. HT-001 is targeted to treat these EGFR-induced skin disorders to allow patients to achieve the best potential outcomes of EGFR therapy, as there are currently no approved drugs to specifically treat EGFR inhibitor-induced skin disorders.

In July 2019 Hoth Therapeutics entered into a Sponsored Research Agreement with the George Washington University (GW) to explore preclinical pharmacology studies with topically administered HT-001.

Currently in the preclinical stage of development of HT-001, Hoth Therapeutics anticipates a meeting with the FDA to be scheduled during the first quarter of 2021. HT-001 is being positioned for submission via the 505(b)(2) development pathway, in which Hoth Therapeutics intends to rely on information not obtained through right of reference in order to reduce the nonclinical and clinical program and expedite time to NDA submission. During the pre-IND meeting with the FDA, Hoth Therapeutics plans to discuss the overall proposed drug development program for HT-001 including requirements for nonclinical, clinical pharmacology, clinical, and chemistry, manufacturing, controls. Hoth also plans to present clinical trial designs for the IND-opening, phase 2a dose ranging study as well as a proposed follow-up phase 2b safety and efficacy dose extension study; both studies will be conducted in cancer patients receiving EGFR inhibitor therapy.

"Palliative care treatment for cancer patients continues to be an underserved segment of the market that our HT-001 product has an opportunity to provide patients with a better quality of life during their cancer treatment," stated Robb Knie, Chairman and CEO of Hoth Therapeutics. "We look forward to working closely with the FDA on our Phase 2a and Phase 2b trial designs and advancing HT-001 through the research and development process."

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 HT-001 and how does it help cancer patients?

HT-001 is a topical drug being developed by Hoth Therapeutics to treat skin disorders caused by EGFR inhibitor therapy, addressing an unmet need among cancer patients.

When is Hoth Therapeutics' FDA meeting for HT-001 scheduled?

The FDA meeting to discuss HT-001 is anticipated to occur in the first quarter of 2021.

What indications does HT-001 target?

HT-001 specifically targets skin disorders associated with epidermal growth factor receptor (EGFR) inhibitor therapy.

How significant are the side effects of EGFR inhibitors?

Over 50% of cancer patients undergoing EGFR inhibitor therapy experience significant dermatological side effects within the first two weeks.

What regulatory pathway is Hoth Therapeutics using for HT-001?

Hoth Therapeutics is pursuing a 505(b)(2) development pathway for HT-001, which may expedite the NDA submission process.