Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), a late clinical-stage
biopharmaceutical company whose mission is to focus on unmet needs
and apply proven science and new technology to revolutionize
treatment for patients, starting with eye care, today announced
that the U.S. Food and Drug Administration (FDA) has accepted the
Company’s Investigational New Drug (IND) application for TP-05, an
oral, non-vaccine therapeutic for the prevention of Lyme disease.
With this IND acceptance, Tarsus will initiate a Phase 1 single
ascending dose and multiple ascending dose (SAD/MAD) study to
evaluate the safety, tolerability, and pharmacokinetics (PK) of
TP-05 in healthy volunteers. Study initiation is anticipated in
July.
“We are pleased that the FDA has accepted the IND for TP-05,
which is an important milestone in our pipeline development.
Currently, there are no approved pharmacological prophylactic
options for tick kill and preventing transmission of Lyme disease,
which has the potential to cause severe, often debilitating
symptoms with permanent and irreversible damage,” said Bobak
Azamian, M.D., Ph.D., President and Chief Executive Officer of
Tarsus. “There is a significant unmet need for a therapeutic to
quickly and reliably prevent this disease that can lead to poor
outcomes for so many people. We look forward to initiating our
clinical development program for TP-05 and advancing the path for
this much-needed therapeutic for Lyme disease prevention.”
Lyme disease is transmitted to humans after the bite of a
blacklegged tick infected with the Borrelia bacteria. It is the
most common vector-borne disease in the United States and can
result in inflammation, nerve, joint and muscle pain and swelling,
numbness, shortness of breath and – in severe cases – neurological
complications such as facial palsy, vision issues, and meningitis
symptoms, including severe headaches and neck stiffness. Lyme
disease impacts more than 300,000 people in the U.S. each year and
over 30 million are at high or moderate risk for contracting the
disease.
TP-05 is an oral systemic formulation of lotilaner, a
well-characterized anti-parasitic agent that paralyzes and kills
ticks by blocking the parasite-specific GABA-CI channels. TP-05 is
believed to be the only non-vaccine based therapeutic in
development and is designed to rapidly provide systemic blood
levels of lotilaner, and kill infected ticks attached to the human
body before they can transmit the Borrelia bacteria that causes
Lyme disease. In addition to the prevention of Lyme disease, Tarsus
is also exploring TP-05 for the community prevention of
malaria.
Tarsus is currently conducting a pivotal trial evaluating the
efficacy and safety of TP-03, a topical ophthalmic formulation of
lotilaner, for the treatment of Demodex blepharitis, a common
ocular condition caused by an infestation of Demodex mites.
About TP-05TP-05 is an oral systemic
formulation of lotilaner, a well-characterized anti-parasitic agent
that paralyzes and kills parasites by inhibiting parasite-specific
GABA-Cl channels. Tarsus is studying TP-05 for the prevention of
Lyme disease. In July of 2021, Tarsus will initiate a Phase 1
single ascending dose and multiple ascending dose (SAD/MAD) study
to evaluate the safety, tolerability and pharmacokinetics (PK) of
TP-05 in healthy volunteers. In addition to Lyme disease, Tarsus is
also exploring TP-05 for the community prevention of malaria.
About Lyme DiseaseLyme disease is the most
common vector-borne disease in the United States, transmitted to
humans after the bite of a blacklegged tick infected by the
bacterium Borrelia burgdorferi. Over 30 million Americans are at
high or moderate risk of contracting Lyme disease and there are
approximately 300,000 – 400,000 cases in the U.S. each year. People
who spend extended amounts of time outdoors in wooded, grassy areas
are at higher risk of getting the infection. Data from the Centers
for Disease Control (CDC) shows that the risk of Lyme disease is
spreading to new geographical areas, resulting in a significant
need for prophylactic solutions. Currently, there are no
FDA-approved pharmacological prophylactic options for Lyme
disease.
About Tarsus Pharmaceuticals, Inc.Tarsus
Pharmaceuticals, Inc. is a late clinical-stage biopharmaceutical
company that applies proven science and new technology to
revolutionize treatment for patients, starting with eye care. It is
advancing its pipeline to address several diseases with high unmet
need across a range of therapeutic categories, including eye care,
dermatology, and infectious disease prevention. Its lead product
candidate, TP-03, is a novel therapeutic in a pivotal Phase 2b/3
trial for the treatment of Demodex blepharitis. TP-03 is also being
developed for the treatment of Meibomian Gland Disease.
Forward-Looking Statements Statements in this
press release about future expectations, plans and prospects, as
well as any other statements regarding matters that are not
historical facts, may constitute “forward-looking statements.”
These statements include statements regarding the market size for
TP-03, TP-05, future events and Tarsus’ plans for and the
anticipated benefits of its product candidates including TP-03,
TP-05, the timing, objectives and results of the clinical studies
and anticipated regulatory and development milestones and the
quotations of Tarsus’ management. The words, without limitation,
“believe,” “contemplate,” “continue,” “could,” “estimate,”
“expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,”
“project,” “should,” “target,” “will” or “would” or the negative of
these terms or other similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these or similar identifying words. Actual
results may differ materially from those indicated by such
forward-looking statements as a result of various important
factors. Important factors that could cause actual results to
differ materially from those in the forward-looking statements
include: Tarsus has incurred significant losses and negative cash
flows from operations since inception and anticipates that it will
continue to incur significant expenses and losses for the
foreseeable future; Tarsus may need to obtain additional funding to
complete the development and any commercialization of its product
candidates, if approved; Tarsus is heavily dependent on the success
of its lead product candidate, TP-03 for the treatment of Demodex
blepharitis; the COVID-19 pandemic may affect Tarsus’ ability to
initiate and complete preclinical studies and clinical trials,
disrupt regulatory activities, disrupt manufacturing and supply
chain or have other adverse effects on Tarsus’ business and
operations; even if TP-03, TP-05 or any other product candidate
that Tarsus develops receives marketing approval, Tarsus may not be
successful in educating physicians and the market about the need
for treatments specifically for Demodex blepharitis, Lyme disease
and or other diseases or conditions targeted by Tarsus’ products;
the development and commercialization of Tarsus products is
dependent on intellectual property it licenses from Elanco
Tiergesundheit AG; Tarsus will need to develop and expand the
company and Tarsus may encounter difficulties in managing its
growth, which could disrupt its operations; the sizes of the market
opportunity for Tarsus’ product candidates, particularly TP-03 for
the treatment of Demodex blepharitis and MGD, as well as TP-05 for
the treatment of Lyme disease, have not been established with
precision and may be smaller than estimated; the results of Tarsus’
earlier studies and trials may not be predictive of future results;
any termination or suspension of, or delays in the commencement or
completion of, Tarsus’ planned clinical trials could result in
increased costs, delay or limit its ability to generate revenue and
adversely affect its commercial prospects; and if Tarsus is unable
to obtain and maintain sufficient intellectual property protection
for its product candidates, or if the scope of the intellectual
property protection is not sufficiently broad, Tarsus’ competitors
could develop and commercialize products similar or identical
Tarsus’ product. Further, there are other risks and uncertainties
that could cause actual results to differ from those set forth in
the forward-looking statement and they are detailed from time to
time in the reports Tarsus files with the Securities and Exchange
Commission, including Tarsus’ Form 10-K for the year ended December
31, 2020 filed with the SEC on March 31, 2021, which Tarsus
incorporates by reference into this press release, copies of which
are posted on its website and are available from Tarsus without
charge. However, new risk factors and uncertainties may emerge from
time to time, and it is not possible to predict all risk factors
and uncertainties. Accordingly, readers are cautioned not to place
undue reliance on these forward-looking statements. Any
forward-looking statements contained in this press release are
based on the current expectations of Tarsus’ management team and
speak only as of the date hereof, and Tarsus specifically disclaims
any obligation to update any forward-looking statement, whether as
a result of new information, future events or otherwise.
Contacts:
Media Contact:SuJin Oh Shop PR(917)
841-5213sujin@shop-pr.com
Investor Contact:Patti BankWestwicke Partners, an ICR
company(415) 513-1284IR@tarsusrx.com
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