Hoth Therapeutics Launches Expanded Access Initiative for HT-001, Offering Critical Relief to Cancer Patients Facing Severe Skin Toxicities
- Encouraging signals reported from Phase 2a open-label cohort study
- Large addressable market with over 100,000 cancer patients annually receiving EGFR inhibitors
- No currently approved targeted treatments for EGFR-inhibitor-induced skin toxicities
- EAP status could accelerate path to commercialization
- Potential to generate additional real-world data through expanded access program
- Drug is still in early clinical development phase
- Efficacy and safety profile not yet fully established
- Success in expanded access program not guaranteed
Insights
Hoth's EAP initiative for HT-001 advances their lead asset toward commercialization while addressing significant unmet medical needs in oncology supportive care.
Hoth Therapeutics' move to establish an Expanded Access Program for HT-001 represents a significant strategic advancement for their lead asset. The EAP application, supported by Premier Research, will provide compassionate access to patients suffering from EGFR inhibitor-induced skin toxicities—a condition affecting a substantial portion of the 100,000+ cancer patients receiving EGFR inhibitors annually.
This development carries multiple strategic advantages. First, it suggests positive clinical signals from their ongoing Phase 2a study, as companies typically don't pursue expanded access without encouraging efficacy data. Second, it creates an accelerated pathway to real-world usage, generating valuable clinical experience and data outside traditional trial settings.
From a market perspective, HT-001 addresses a clear unmet need with no currently approved targeted treatments for these specific skin toxicities. The compassionate use program will enhance physician awareness and potentially build a prescriber base before formal approval. This approach effectively de-risks the commercialization pathway while demonstrating commitment to patient access.
Perhaps most telling is the company's strategic positioning of HT-001 within the growing oncology supportive care market. Rather than competing directly with primary cancer treatments, Hoth is targeting the quality-of-life segment, where payer resistance may be lower and patient advocacy stronger. This EAP initiative effectively bridges the gap between clinical development and commercial launch, potentially accelerating time-to-revenue for their lead asset.
Premier Research to support submission of an Expanded Access Program (EAP) application.
This move positions Hoth to offer compassionate access to HT-001 for cancer patients suffering from painful and debilitating skin toxicities caused by epidermal growth factor receptor (EGFR) inhibitor therapies—an area of high unmet medical need.
"We're seeing encouraging signals from our open-label Phase 2a cohort and are taking bold steps to accelerate availability for patients in need," said Robb Knie, Chief Executive Officer of Hoth Therapeutics. "This Expanded Access initiative not only reflects our dedication to patient care but also enhances HT-001's clinical visibility and commercial potential."
HT-001 has shown promising signs of clinical benefit in early evaluations, and now Hoth is preparing to make the investigational drug available to qualified patients outside of ongoing clinical trials. Expanded Access—often referred to as "compassionate use"—represents an important regulatory pathway that allows patients ineligible for traditional trials to gain access to experimental treatments when no approved alternatives exist.
"We're seeing encouraging signals from our open-label Phase 2a cohort and are taking bold steps to accelerate availability for patients in need," said Robb Knie, Chief Executive Officer of Hoth Therapeutics. "This Expanded Access initiative not only reflects our dedication to patient care but also enhances HT-001's clinical visibility and commercial potential."
The strategic move expands HT-001's reach and reinforces Hoth's long-term vision to be a leader in cancer supportive care. With a clearly defined regulatory pathway, a fast-growing addressable market, and no currently approved targeted treatment for EGFR-inhibitor-induced skin toxicities, HT-001 is uniquely positioned to capture attention from both the medical community and the investor marketplace.
Why It Matters for Investors
- High Unmet Need: Over 100,000 cancer patients annually receive EGFR inhibitors, with the majority experiencing skin toxicities that currently lack targeted treatments.
- Strong Market Potential: HT-001 targets a rapidly growing segment in oncology supportive care.
- Regulatory Momentum: Expanded Access status creates a faster route to commercialization and increases real-world data generation.
Investors and partners are encouraged to monitor updates closely as Hoth Therapeutics continues to advance HT-001 toward its next key inflection points.
For more information about HT-001, clinical trials, or Expanded Access eligibility, visit www.hoththerapeutics.com.
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, and the timing and costs of other expenses; market acceptance of our products; the ultimate impact of any 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, and 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 titled "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
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