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
data from its Demodex blepharitis clinical program presented at the
virtual Association for Research in Vision and Ophthalmology (ARVO)
2021 Annual Meeting. Demodex blepharitis is a common ocular disease
that may affect as many as 25 million Americans and has both
clinical and psychosocial impacts. Characterized by inflammation of
the eyelid margin, redness and ocular irritation, Demodex
blepharitis is caused by an infestation of Demodex mites.
Currently, there is no FDA-approved therapy for the disease.
Tarsus’ lead product candidate, TP-03, is a topical ophthalmic
formulation of lotilaner, a well-characterized anti-parasitic
agent, designed to target and eradicate Demodex mites, and is
currently being evaluated in the pivotal Phase 2b/3 Saturn-1 trial.
Although highly prevalent, Demodex blepharitis is often
overlooked or misdiagnosed and – as a result – patients may
struggle with the condition for years. Until now, the psychosocial
effects of Demodex blepharitis have been poorly characterized. The
Atlas study is the first multi-center
observational study to evaluate the functional and psychosocial
impact of the disease, along with clinical manifestations, in adult
patients. Overall, the study showed that Demodex blepharitis is
associated with a significant symptomatic and psychosocial burden,
negatively affecting daily life in the majority (80%) of patients
with the disease.
“The results from the Atlas study are significant because they
demonstrate that there are severe functional and psychosocial
impacts related to Demodex blepharitis with regard to routine,
everyday activities and overall quality of life,” said Elizabeth
Yeu, M.D., Chief Medical Advisor for Tarsus. “The study underscores
the importance of identifying the disease sooner, as well as the
need for a safe, effective therapy that may provide substantial
relief to this patient population. Tarsus is committed to
progressing their clinical program in this area to develop a
therapy that may address the underlying cause of Demodex
blepharitis.”
The Atlas study surveyed 311 patients who were pre-screened at 8
sites participating in Tarsus’ pivotal Phase 2b/3 Saturn-1 trial.
Patients had three objective signs of Demodex blepharitis,
including the presence of Demodex mites; presence of collarettes on
the lashes, also known as cylindrical dandruff, which are a
pathognomonic sign of Demodex blepharitis; and lid margin erythema.
Patients were asked questions about ocular symptoms, diagnoses, and
history and their questionnaire responses were analyzed. The study
found that the functional and psychosocial burdens of Demodex
blepharitis are considerable, leading patients to seek treatment
and medical care, mostly unsuccessfully:
- More than half of patients (51%) said they had signs
and symptoms of blepharitis for at least four years, but
most (58%) reported they had never been diagnosed, even though a
third had made at least two and sometimes more than six visits to a
doctor seeking relief.
- Patients reported their most bothersome
symptoms were itchy eyes and dry eyes, with the majority
(52%) experiencing these symptoms frequently or all the time in the
past month.
- Many patients said they were emotionally
affected, with almost half (47%) conscious of their eyes
all day, nearly a quarter (23%) constantly worrying about their
eyes and 23% saying it gave their eyes or eyelids a negative
appearance to others.
- The disease also affected their daily
activities, with almost half (47%) reporting difficulty
driving at night and nearly a third (30%) saying it added time to
their daily hygiene routine.
- Most patients (81%) had sought treatment, but
many of these patients discontinue treatment, citing
ineffectiveness, tolerability, or other reasons.
“The Atlas study reveals the need for a proven treatment for
Demodex blepharitis to treat patients’ disease and end the daily
toll it takes on their ocular health and quality of life,” said
Bobak Azamian, M.D., Ph.D., President and Chief Executive Officer
of Tarsus. “Our goal is to offer patients and eye care
professionals the first drug treatment that targets the underlying
cause of disease, and may positively impact the significant disease
burden. We remain focused on advancing our pivotal TP-03 clinical
program and we look forward to initiating Saturn-2 this quarter and
announcing the results of Saturn-1 this summer.”
Tarsus also presented the complete findings of the
Europa study, a prospective, randomized,
vehicle-controlled Phase 2b trial that evaluated the safety and
efficacy of twice-daily TP-03, topical lotilaner ophthalmic
solution 0.25%, in adult patients with Demodex blepharitis.
Enrolled participants received no treatment for blepharitis
symptoms (i.e., lid hygiene) during the study, as well as at least
14 days prior.
- In the trial, TP-03 demonstrated statistically significant
results for the primary endpoint, collarette cure over vehicle,
which was achieved in 80% of patients versus 16%, respectively, at
42 days (p<0.001).
- Furthermore, TP-03 demonstrated statistically significant
results for the secondary endpoints. Mites were eradicated in 73%
of patients treated with TP-03 compared to 21% of the vehicle group
(p=0.003) and composite collarette and erythema cure was achieved
in 73% of patients treated with TP-03 compared to 11% of the
vehicle group, both at 42 days (p<0.001).
- In post hoc analyses, 93% of patients treated with TP-03 had a
clinically meaningful outcome of 10 or fewer lashes with
collarettes by day 42.
- Additional post-hoc analyses showed that 87% of patients
treated with TP-03 had mite density reduced by 50% or more by day
14.
- There were no serious adverse events and no discontinuations
due to adverse events.
The positive results observed in the Europa study were used as
the basis for the pivotal Phase 2b/3 Saturn-1 and Phase 3 Saturn-2
trials of TP-03 to treat 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
pivotal Phase 2b/3 trial. 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 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 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, 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 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 or any other product candidate that
Tarsus develops receives marketing approval, Tarsus may not be
successful in educating eye care physician 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
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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