Hoth Therapeutics Announces Expansion of FDA Cleared First-In-Human Clinical Trial For Cancer Patients of HT-001 at University of Miami
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The approval for Hoth Therapeutics to enroll patients in its Phase 2a clinical trial represents a significant step in the development pipeline for its lead therapeutic candidate HT-001. The focus on skin toxicities associated with Epidermal Growth Factor Receptor Inhibitors (EGFRi) addresses a specific adverse effect that can significantly impact patients' quality of life and compliance with cancer treatments. As skin toxicities are a common and often debilitating side effect of EGFRi therapy, the potential market for HT-001 is substantial, given the widespread use of these inhibitors in oncology.
From a medical research perspective, the randomized, placebo-controlled design of the study is critical for determining the efficacy and safety of HT-001. The dose-ranging aspect will help to identify the optimal therapeutic dose for future studies and eventual market use. The involvement of reputable institutions like the University of Miami, Washington University of St. Louis and MD Anderson Cancer Center adds credibility to the trial and may facilitate patient recruitment due to the centers' recognition in oncology research.
Should HT-001 prove effective, it would not only benefit patients by potentially reducing the incidence or severity of skin toxicities but also could lead to increased adherence to EGFRi therapies, ultimately improving treatment outcomes. However, the development of new therapeutics is inherently risky and the eventual success of HT-001 will depend on the results of this and subsequent trials.
The commencement of a Phase 2a clinical trial is a critical juncture for Hoth Therapeutics from a financial standpoint. Clinical trial outcomes are one of the most significant drivers of biopharmaceutical company valuations, especially for companies like Hoth that are in the development stage without a product on the market. The announcement could have immediate implications for investor sentiment and the company's stock price, as it signals progress in the company's pipeline.
Investors will closely monitor the trial's progress, as positive results could lead to a surge in the company's value, while negative outcomes could have the opposite effect. It is important for investors to consider the long development timelines and the high costs associated with bringing a new drug to market. Biopharmaceutical investing is high risk, with the potential for high reward and the outcomes of this trial will be a key determinant of Hoth Therapeutics' future financial health.
Moreover, securing approval from multiple reputable research institutions might increase investor confidence in the potential of HT-001. This confidence, however, must be balanced with a realistic understanding of the regulatory hurdles and market competition that Hoth Therapeutics will face even if the trial is successful.
The market for treatments of side effects associated with cancer therapies is growing, as the global cancer burden continues to rise and the use of targeted therapies like EGFRi becomes more prevalent. A successful treatment for skin toxicities could see significant demand and offer Hoth Therapeutics a niche but lucrative market segment. Market research indicates that patient-centric treatments that improve quality of life are increasingly valued by both patients and healthcare providers.
Understanding the competitive landscape is crucial and HT-001 will likely face competition from existing and emerging treatments for skin toxicities. It will be important for Hoth Therapeutics to differentiate HT-001 based on efficacy, safety and cost-effectiveness. Additionally, the company should consider strategic partnerships or licensing agreements to maximize market penetration and distribution, particularly if its internal marketing and sales capabilities are limited.
Assessing the addressable market size and the adoption rate of HT-001 will be essential for projecting potential revenue. This includes analyzing the prevalence of skin toxicities among patients on EGFRi therapy and the percentage of those who seek treatment. It is also important to monitor trends in oncology treatment protocols and the development of new EGFRi drugs that may affect the incidence of skin toxicities.
This First-in-Human (FIH) Phase 2a clinical trial of HT-001 for the treatment of skin toxicities associated with Epidermal Growth Factor Receptor Inhibitors (EGFRi). This clinical trial is a randomized, placebo-controlled, parallel Phase 2a dose-ranging study to investigate the efficacy, safety, and tolerability of topical HT-001 for the treatment of skin toxicities associated with EGFRi. More information can be found at clinicaltrials.gov.
"We are very pleased to have received approval for our FIH clinical trial," said Hoth Therapeutics Chief Executive Officer, Robb Knie. "We are hopeful that this trial will demonstrate successful delivery of our lead therapeutic candidate HT-001. Coupled with approval at
About Hoth Therapeutics, Inc.
Hoth Therapeutics 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 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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