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.