Hoth intends to continue development under
Orphan Drug Designation
NEW
YORK, Nov. 14, 2023 /PRNewswire/ -- Hoth
Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company,
today announced today the successful completion of a pre-IND
meeting with the U.S. Food and Drug Administration (FDA) regarding
the Company's development plan for its HT-KIT therapeutic. The
Pre-IND meeting was completed through written responses provided by
the FDA Nonmalignant Hematology Division of Regulatory Operations
for Cardiology, Hematology, Endocrinology, and Nephrology.
HT-KIT is an antisense oligonucleotide that targets the
proto-oncogene cKIT by inducing mRNA frame shifting and already has
Orphan Drug Designation from the FDA.
Hoth Therapeutics, Inc., is developing the drug product HT-KIT
indicated for the treatment of adult patients with AdvSM. HT-KIT is
a single-strand phosphorodiamidate morpholino oligonucleotide
(PMO).
The purpose of the requested meeting was to gain the Agency's
agreement on the suitability the 505(b)(1) regulatory pathway for
approval of HT-KIT; adequacy of referenced nonclinical information
and the proposed drug development plan to support opening the IND;
and to discuss any filing issues the Agency may have with the
proposed product.
The Sponsor was granted Orphan Drug Designation for HT-KIT for
the treatment of mastocytosis.
Based on the FDA's feedback, Hoth intends to advance its
IND-enabling activities for HT-KIT as planned.
"We are very pleased with the outcome of the pre-IND meeting
written responses from the FDA," said Robb
Knie, CEO of Hoth Therapeutics. "The positive feedback from
the FDA is a significant milestone for Hoth in executing our
development of HT-KIT and one step closer to getting this exciting
cancer fighting therapeutic into the clinic and ready for the
patients who would benefit the most."
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.