Hoth
Therapeutics Announces Submission of Orphan Designation Application
for HT-KIT to Treat Mastocytosis
NEW
YORK, NY
December
21, 2021 --
InvestorsHub NewsWire -- Hoth
Therapeutics, Inc. (NASDAQ: HOTH)
a patient-focused clinical-stage
biopharmaceutical company, announced it submitted an Orphan Drug
Designation Application to the US Food and Drug Administration
(FDA) for HT-KIT for the treatment of mastocyctosis. HT-KIT is an
antisense oligonucleotide that targets the proto-oncogene cKIT by
inducing mRNA frame shifting, resulting in apoptosis of neoplastic
mast cells. The KIT signaling pathway is implicated in multiple
diseases, including all types of mastocytosis (such as aggressive
systemic mastocytosis (ASM), mast cell leukemia (MCL), and systemic
mastocytosis with associated hematological neoplasm (SM-AHN)),
acute myeloid leukemia, gastrointestinal stromal tumors, and
anaphylaxis.
Drugs intended to treat orphan diseases (rare
diseases that affect less than 200,000 people in the US)
are eligible to apply for Orphan Drug Designation (ODD), which
provides multiple benefits to the sponsor during development and
after approval. Hoth intends to pursue these benefits as part of
the drug development for HT-KIT for treatment of mastocytosis,
pending designation of the ODD application.
Benefits of Orphan Drug Designation
Under the Orphan Drug Act, drug companies can apply for ODD, and if
granted, the drug will have a status which gives companies
exclusive marketing and development rights along with other
benefits to recover the costs of researching and developing the
drug.
A tax credit of 50% of the qualified clinical drug testing costs
awarded upon drug approval is also possible.
Regulatory streamlining and provide special assistance to companies
that develop drugs for rare patient populations. In addition to
exclusive rights and cost benefits, the FDA will provide protocol
assistance, potential decreased wait-time for drug approval,
discounts on registration fees, and eligibility for market
exclusivity after approval.
Key benefits of ODD:
-
7 years exclusivity
post-approval
-
Tax credits of 50% off
the clinical drug testing cost awarded upon approval
-
Waiver of new drug
application (NDA)/ biologics license application (BLA) application
fee
Hoth
recently announced
that its novel anti-cancer
therapeutic exhibited
highly positive results in humanized mast cell neoplasm models,
representative in vitro and in vivo models for aggressive, mast
cell-derived cancers such as mast cell leukemia and mast cell
sarcoma.
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 indications including
atopic dermatitis, skin toxicities associated with cancer therapy,
chronic wounds, psoriasis, asthma, acne, and pneumonia. Hoth has
also entered into two different agreements to further the
development of two therapeutic prospects to prevent or treat
COVID-19.
To learn
more, please visit www.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
Relations Contact:
LR
Advisors LLC
Email: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com
Phone:
(678) 570-6791
Media Relations
Contact:
Makovsky
Miriam Brito, Assistant Vice
President
Email:
hoth-mak@makovsky.com
Phone: (914)-406-0435
Hoth Therapeutics (NASDAQ:HOTH)
Historical Stock Chart
From May 2024 to Jun 2024
Hoth Therapeutics (NASDAQ:HOTH)
Historical Stock Chart
From Jun 2023 to Jun 2024