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Hoth Therapeutics Announces it Received FDA Approval to Expand HT-001 Clinical Trial to Treat Severely Ill Patients

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Hoth Therapeutics, Inc. (HOTH) has received FDA clearance for protocol amendments to its ongoing clinical trial for HT-001, a potential treatment for cancer patients undergoing treatment of skin toxicities associated with EGFRI. The trial aims to evaluate the efficacy, safety, and tolerability of HT-001 for treatment of EGFRI-induced skin toxicity. The study will be conducted in 2 parallel cohorts and aims to determine the minimum efficacious dose strength(s) for further investigation.
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The FDA clearance for protocol amendments in Hoth Therapeutics' clinical trial for HT-001 represents a significant step forward in the development of treatments for skin toxicities caused by EGFRI cancer therapies. From a clinical research perspective, the ability to enroll patients irrespective of prior treatment failure broadens the potential applicability of the study's findings and may accelerate patient recruitment, a common bottleneck in clinical trials. The study's design, a randomized, double-blind, placebo-controlled trial, is the gold standard for determining drug efficacy and safety, thereby enhancing the robustness of the data collected.

Moreover, the inclusion of a dose-ranging component is critical for determining the minimum effective dose, which can optimize therapeutic outcomes while minimizing potential side effects. This is particularly important in oncology, where the therapeutic window can be narrow. The pharmacokinetics analysis planned for the open-label cohort will provide valuable insights into the drug's absorption and distribution, which is essential for understanding its mechanism of action and potential interactions with other medications commonly used by cancer patients.

From a market perspective, the advancement of HT-001 through clinical trials is a noteworthy event for Hoth Therapeutics and its stakeholders. The treatment of EGFRI-induced skin toxicity represents a niche but important market, as current therapeutic options are limited. The successful development and subsequent approval of HT-001 could position Hoth Therapeutics as a leader in this space, potentially leading to increased investor interest and stock valuation.

It is essential to consider the competitive landscape, as any other companies developing similar treatments could impact Hoth's market share. Furthermore, the long-term commercial success of HT-001 will depend on factors such as pricing, reimbursement and the ability to effectively market the product to healthcare providers. Investors will closely monitor the trial's progress and results, as these will provide indications of the drug's market potential and the company's future revenue streams.

Financially, the FDA's clearance for the amended clinical trial protocol may have implications for Hoth Therapeutics' operational costs and funding requirements. Conducting a Phase 2a study, particularly one that is multi-center and includes pharmacokinetic analysis, can be capital-intensive. Investors should be aware of the company's current cash position and its ability to fund the trial to completion without the need for dilutive financing or partnerships that could affect shareholder value.

As the trial progresses, any positive interim data could act as a value inflection point for the company's stock. However, the inherent risks of drug development, including the possibility of negative results or adverse events, should not be overlooked. It is also important to evaluate the company's broader pipeline and any other potential revenue sources that could mitigate the risk associated with this single asset.

Patients will be able to enroll in trial at any time and regardless of failure from other therapeutics

NEW YORK, Jan. 18, 2024 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, announced today that it has received U.S. Food and Drug Administration (FDA) clearance to implement a number of protocol amendments to its ongoing clinical trial for HT-001, which is being developed as a potential treatment for cancer patients undergoing treatment of skin toxicities associated with Epidermal Growth Factor Receptor Inhibitors (EGFRI). The trial is being conducted under Hoth's open Investigational New Drug Application (IND) for HT-001.

"We are extremely pleased to announce clearance of our clinical trial optimization plan for HT-001.   Armed with positive initial data and a clean safety profile to date, we believe that these protocol amendments could ultimately result in the generation of a highly compelling data set which could support patients suffering from the effects of EGFRI cancer treatment. These latest developments underscore Hoth Therapeutics' continued commitment to delivering a safe and effective treatment for this very underserved patient population," said Robb Knie, Chief Executive Officer of Hoth Therapeutics.

This is a randomized, double-blind, placebo-controlled, multi-center Phase 2a dose-ranging study to evaluate the efficacy, safety, and tolerability of HT-001 for treatment of EGFRI-induced skin toxicity. The study will include adult patients (≥ 18 years of age) receiving EGFRI therapy.

The study will be conducted in 2 parallel cohorts: Part 1, an open-label cohort consisting of 12 patients to measure pharmacokinetics of HT 001 gel and Part 2, a randomized, parallel arm study comparing 3 dose strengths of HT-001 gel to placebo (HT 001 vehicle). Patients in the randomized cohorts will be randomly assigned to 1 of the 4 treatment arms in a 2:2:2:1 ratio (active groups = 2: placebo = 1).

All patients in both open-label and blinded cohorts will apply the study drug once a day to each area affected with cutaneous toxicity up to 30% body surface area (BSA) involvement, inclusive of skin, scalp, and nails.

The goal of the study is to determine the minimum efficacious dose strength(s) for further investigation. The dose effect, together with the application site safety assessments, and therapeutic effects based on the primary and secondary endpoints will be evaluated.

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 skin toxicities associated with cancer therapy, mast-cell derived cancers and anaphylaxis, Alzheimer's Disease, atopic dermatitis and other indications. 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

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SOURCE Hoth Therapeutics, Inc.

The purpose of the clinical trial is to evaluate the efficacy, safety, and tolerability of HT-001 for treatment of EGFRI-induced skin toxicity in cancer patients.

The study is a randomized, double-blind, placebo-controlled, multi-center Phase 2a dose-ranging study that will be conducted in 2 parallel cohorts.

The goal of the study is to determine the minimum efficacious dose strength(s) for further investigation and evaluate the dose effect, application site safety assessments, and therapeutic effects based on primary and secondary endpoints.

The ticker symbol for Hoth Therapeutics, Inc. is HOTH.
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About HOTH

hoth therapeutics, inc., a biopharmaceutical company, focuses on developing therapies for dermatological disorders. the company focuses on therapies for patients suffering from indications, including eczema, chronic wounds, psoriasis, asthma, and acne. it intends to use the biolexa platform to develop two topical cream products that treat eczema and reduces post-procedure infections for patients undergoing aesthetic dermatology procedures. the company has license agreements with the george washington university; the university of maryland baltimore; isoprene pharmaceuticals, inc.; the north carolina state university; chelexa biosciences, inc.; and the university of cincinnati. it also has a partnership agreement with zyl㶠therapeutics inc. co-develop a new topical treatment for patients with cutaneous lupus erythematosu, a chronic autoimmune disease that affects the skin and is associated with a significant burden on patient quality of life. hoth therapeutics has research collaboratio