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 it has commenced enrollment in Saturn-2, its second pivotal
trial evaluating the company’s novel investigational treatment,
TP-03, in patients with Demodex blepharitis. Up to 25 million
Americans may be affected by Demodex blepharitis, which is caused
by an infestation of Demodex mites. TP-03 is a topical ophthalmic
formulation of lotilaner, a well-characterized anti-parasitic agent
designed to target and eradicate Demodex mites. Tarsus also
recently completed full enrollment for the Saturn-1 pivotal trial,
with 421 patients; topline results of the trial are expected to be
announced this July.
Demodex blepharitis is a common, yet often overlooked or
misdiagnosed, ocular disease that is characterized by inflammation
of the eyelid margin, redness and ocular irritation. The disease is
associated with significant clinical, functional and psychosocial
burdens, with the recently presented Atlas study revealing that the
majority of patients (80%) say the disease negatively affects their
daily life. Currently, there is no FDA-approved therapy for the
disease.
“We are pleased to complete first patient visits in Saturn-2,
our second pivotal trial of TP-03 in Demodex blepharitis,” said
Bobak Azamian, M.D., Ph.D., President and Chief Executive Officer
of Tarsus. “Fully enrolling the Saturn-1 trial in a timely manner
underscores patients’ significant need for a safe and effective
therapy, and we look forward to sharing the topline results this
July. Demodex blepharitis can have a major impact on patients as
evidenced by the Atlas study of participants pre-screened for
Saturn-1. We are committed to progressing TP-03 with the goal of
potentially providing the first FDA-approved drug treatment for
this disease.”
The Saturn-2 trial has a similar design to Saturn-1, and is a
randomized, controlled, multicenter, double-masked trial studying
the safety and efficacy of TP-03, lotilaner ophthalmic solution
0.25%, in adults with Demodex blepharitis. The trial’s primary
endpoint is the proportion of patients achieving collarette cure,
defined as 0 to 2 eyelashes with collarettes. Secondary endpoints
include the eradication of Demodex mites and the proportion of
patients achieving a cure based on a composite of collarette cure
and erythema cure (eyelid redness). We expect Saturn-2 to enroll
approximately 418 participants who will administer TP-03 or vehicle
twice daily for 42 days.
Tarsus has completed four Phase 2 clinical trials of TP-03 in
Demodex blepharitis, all of which met their respective endpoints
with no significant adverse events nor any events leading to
treatment discontinuation. The positive results from these trials
guided the design of the Saturn-1 and Saturn-2 pivotal trials. If
the Saturn-1 and Saturn-2 trials are positive, we expect they will
support the submission of a New Drug Application (NDA) to the
United States Food and Drug Administration (FDA) for TP-03 for the
treatment of Demodex blepharitis.
About TP-03TP-03 (lotilaner ophthalmic
solution, 0.25%) is a novel, investigational therapeutic designed
to target and eradicate Demodex mites. It is a potent,
non-competitive antagonist of insect and arachnid GABA-Cl channels
and a highly lipophilic molecule, which may promote its uptake in
the oily sebum of the hair follicle where the mites reside. Tarsus
has completed four Phase 2 clinical trials of TP-03 in Demodex
blepharitis, all of which met their respective endpoints with no
significant adverse events nor any events leading to treatment
discontinuation. TP-03 is currently being evaluated in the Saturn-1
and Saturn-2 pivotal trials. If approved, TP-03 may offer treatment
for millions of patients around the world with Demodex
blepharitis.
About Demodex BlepharitisBlepharitis is a
common ocular condition that is characterized by inflammation of
the eyelid margin, redness and ocular irritation. Demodex
blepharitis is caused by infestation of Demodex mites, the most
common ectoparasite found on humans. Demodex mites cause
approximately 45% of blepharitis, or about 9 million cases in the
US and the number may be as high as approximately 25 million based
on Tarsus’ internal research indicating about 58% of patients
presenting to eye care clinics have collarettes, a pathognomonic
sign of Demodex infestation, and a published study estimating that
at least 45 million people annually visit an eye care clinic.
Currently, there are no FDA-approved treatments for Demodex
blepharitis.
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 being studied in two
pivotal trials for the treatment of Demodex blepharitis. TP-03 is
also being developed for the treatment of Meibomian Gland
Disease.
Forward-Looking StatementsStatements 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, enrollment expectations in the Saturn-2 trial, timing of
topline data for Saturn-1, future events and Tarsus’ plans for and
the anticipated benefits of its product candidates, including
TP-03, the timing, objectives and results of the clinical trials
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 or any other product candidate that
Tarsus develops receives marketing approval, Tarsus may not be
successful in educating eye care physicians and the market about
the need for treatments specifically for Demodex blepharitis 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, 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 to
Tarsus’ products. 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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