Highlights:
- 100% of Patients in Cohort 1 Achieve Primary Efficacy
Endpoint
- No Treatment-Related Adverse Effects Observed
- Preserves Cancer Treatment Efficacy with Zero Dose
Reductions
NEW
YORK, Jan. 7, 2025 /PRNewswire/ -- Hoth
Therapeutics, Inc. (NASDAQ: HOTH), a leading biopharmaceutical
company focused on patient-centric solutions, today shared
encouraging interim safety and efficacy results from its Phase 2a
clinical trial of HT-001, designed to address skin toxicities
linked to Epidermal Growth Factor Receptor Inhibitors (EGFRi) in
cancer patients.
Exceptional Patient Outcomes:
Data from the open-label portion of the CLEER-001 trial
demonstrated remarkable success:
- 100% of patients achieved the primary efficacy endpoint
of an ARIGA score ≤1, showing significant skin toxicity improvement
by the six-week mark.
- 66% of patients reported reduced pain and itching
scores, further enhancing quality of life.
Crucially, all patients maintained their full EGFRi
dosage, preserving the cancer treatment's full therapeutic
effect—a notable improvement compared to past reports showing
widespread dose reductions or treatment halts due to skin-related
side effects.
A Groundbreaking Approach:
The trial uses the proprietary Acneiform Rash Investigator
Global Assessment Scale (ARIGA), developed in collaboration with
onco-dermatology experts. The innovative scale ensures precise
measurement and assessment of skin toxicity improvements.
Robb Knie, CEO of Hoth
Therapeutics, remarked, "These results are a significant milestone,
underscoring HT-001's potential to transform patient care by
mitigating debilitating skin toxicities while maintaining critical
cancer treatments. Our data highlight HT-001's strong safety
profile and the potential for it to set a new standard of care in
this underserved area."
A Strong Safety Profile:
No treatment-related adverse effects have been reported,
reaffirming HT-001's excellent tolerability.
Looking Ahead:
"These interim findings align with a recent case report of rapid
resolution of EGFRi-induced skin conditions using HT-001," added
Knie. "As the study progresses, we anticipate further validating
these results and are excited about the potential impact HT-001
could have on patient outcomes."
Hoth Therapeutics is committed to advancing groundbreaking
treatments and improving patient lives through innovative therapies
like HT-001. Full results from this trial are eagerly awaited as
patient enrollment continues.
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 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, 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.