FDA Approved Trial Now Has Two Sites Approved
with Additional Sites in Approval Process
Recruitment of Patients to Accelerate
NEW
YORK, July 19, 2023 /PRNewswire/ -- Hoth
Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused
biopharmaceutical company, today announced that it has received
approval from the Food & Drug Administration ("FDA") for a
protocol change in its Phase 2a clinical trial of HT-001.
Participants will apply HT-001 Gel once per day for 6 weeks, during
which the effect on treating acneiform rash and other skin
disorders induced by EGFRI therapy will be evaluated using
different assessment tools to measure severity of rash, pain, and
itching (pruritus), as well as the change in quality of life.
The study will be completed in 2 parts: the first part is an
open-label (unblinded) cohort and all patients will receive HT-001
topical gel with the active ingredient; the second part is a
randomized, placebo-controlled, parallel Phase 2a dose-ranging
study and patients will be randomized to receive one of three
concentrations of HT-001 or placebo. Hoth will compare HT-001 to
the placebo in the second period to see if HT-001 provides a
significant treatment effect.
"With our recent change in protocol approved, we believe
that HT-001 for the treatment of skin toxicities
associated with Epidermal Growth Factor Receptor Inhibitors will be
more widely available for patients suffering from chemo rash,"
stated Hoth Therapeutics Chief Executive Officer, Robb
Knie.
More information on the trial can be found at
clinicaltrials.gov.
About Hoth Therapeutics, Inc.
Hoth Therapeutics is a
clinical-stage biopharmaceutical company dedicated to develop
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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SOURCE Hoth Therapeutics, Inc.