Hoth Therapeutics Announces FDA Acceptance of IND Application for HT-001 for the Treatment of Cancer Disorders Associated with Epidermal Growth Factor Receptor (EGFR) Inhibitor Therapy

Rhea-AI Summary

Hoth Therapeutics, Inc. (NASDAQ: HOTH) announced that the FDA accepted its IND application for HT-001, aimed at treating skin disorders from EGFR inhibitor therapy. This marks a vital step towards addressing unmet needs in cancer treatment, as current options for skin toxicities are limited. CEO Robb Knie expressed optimism about advancing to a Phase 2a trial expected in Q1 2023. This development illustrates Hoth's commitment to enhancing patient quality of life and indicates a critical progression in the onco-dermatology field.

Positive

• FDA acceptance of IND application for HT-001 is a significant regulatory milestone.
• HT-001 targets a critical unmet need in treating skin disorders linked to EGFR inhibitors, which are used in various cancers.
• Anticipation of a Phase 2a trial beginning in Q1 2023 suggests ongoing commitment to drug development.

Negative

• None.

On-track to initiate Phase 2 trial in Q1 2023

NEW YORK, Dec. 29, 2022 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted an Investigational New Drug (IND) application for the company's HT-001 therapeutic for the treatment for 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.

"We are excited to begin our trial and bring hope to patients who are suffering.  With no specific treatment currently approved for the treatment of skin toxicities associated with EGFRi therapies, this trial brings us one step closer to a new treatment option for underserved cancer patients," said Robb Knie, CEO of Hoth Therapeutics, Inc. "We look forward to advancing HT-001 into the clinical phase as we believe that this novel therapeutic will be a key treatment in the onco-dermatology space. We anticipate beginning our Phase 2a trial in Q1 of 2023.

About Hoth Therapeutics, Inc.

Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to developing innovative, impactful, and ground-breaking treatments with a goal to improve patient quality of life. We are a catalyst in early-stage pharmaceutical research and development, elevating drugs from the bench to pre-clinical and clinical testing. Utilizing a patient-centric approach, we collaborate and partner with a team of scientists, clinicians, and key opinion leaders to seek out and investigate therapeutics that hold immense potential to create breakthroughs and diversify treatment options.  To learn more, please visit https://ir.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 Hoth may develop, and the labeling under any approval Hoth may obtain; the timing and costs of clinical trials, the timing and costs of other expenses; market acceptance of Hoth's products; the ultimate impact of the current Coronavirus pandemic, or any other health epidemic, on Hoth's business, its clinical trials, its research programs, healthcare systems or the global economy as a whole; Hoth's intellectual property; Hoth's reliance on third party organizations; Hoth's competitive position; Hoth's industry environment; Hoth's anticipated financial and operating results, including anticipated sources of revenues; Hoth's assumptions regarding the size of the available market, benefits of Hoth's products, product pricing, timing of product launches; management's expectation with respect to future acquisitions; statements regarding Hoth's goals, intentions, plans and expectations, including the introduction of new products and markets; and Hoth's 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 undue 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 Hoth believes that the expectations reflected in the forward-looking statements are reasonable, Hoth 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 of this press release. Consequently, forward-looking statements should be regarded solely as Hoth's current plans, estimates, and beliefs. Hoth cannot guarantee future results, events, levels of activity, performance or achievements. Hoth does not undertake and specifically declines any obligation to update 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

View original content to download multimedia:https://www.prnewswire.com/news-releases/hoth-therapeutics-announces-fda-acceptance-of-ind-application-for-ht-001-for-the-treatment-of-cancer-disorders-associated-with-epidermal-growth-factor-receptor-egfr-inhibitor-therapy-301711012.html

SOURCE Hoth Therapeutics, Inc.

FAQ

What is the significance of the FDA's acceptance of Hoth Therapeutics' IND application for HT-001?

The FDA's acceptance is crucial as it allows Hoth Therapeutics to move forward with clinical trials for HT-001, addressing skin disorders associated with EGFR inhibitor therapy.

When does Hoth Therapeutics plan to start the Phase 2 trial for HT-001?

Hoth Therapeutics anticipates beginning the Phase 2a trial for HT-001 in Q1 2023.

What are EGFR inhibitors and why are they important?

EGFR inhibitors are therapeutic agents used in treating various cancers, including non-small cell lung cancer and pancreatic cancer, but can cause skin disorders that HT-001 aims to treat.

What does HT-001 target?

HT-001 targets skin toxicities associated with EGFR inhibitor therapy, which currently lacks approved treatment options.