Tarsus Announces Positive Topline Data from Saturn-2 Phase 3, the Second Pivotal Trial of TP-03 for the Treatment of Demodex Blepharitis, and Expects to File a New Drug Application This Year
May 02 2022 - 7:00AM
Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), 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 TP-03 (lotilaner ophthalmic solution, 0.25%) met the
primary endpoint and all secondary endpoints in the Saturn-2
pivotal Phase 3 trial with a favorable safety profile, reinforcing
its ability to resolve Demodex blepharitis, a highly prevalent
eyelid disease. With these positive results, Tarsus plans to submit
a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) in the second half of 2022.
“The positive Saturn-2 data builds on the compelling results we
observed in Saturn-1, demonstrating clear consistency in the
safety, efficacy and strong clinical value proposition of TP-03.
This milestone enables a first potential treatment for Demodex
blepharitis and most importantly, provides hope to the millions of
patients suffering from this disease,” said Bobak Azamian, M.D.,
Ph.D., President and Chief Executive Officer of Tarsus. “As we
direct our focus toward NDA filing and commercialization, we are
one step closer to providing a solution to eye care professionals
and patients that can resolve this disease. We are truly grateful
to the many patients who participated in the trial and appreciate
their time and commitment despite the challenges presented by the
ongoing COVID-19 pandemic. We are also sincerely thankful for the
investigators and our clinical team who skillfully drove the
execution of this successful trial. We’re thrilled to move the
regulatory path forward for TP-03, which – if approved by the FDA –
will potentially establish a definitive standard of care for
Demodex blepharitis and benefit as many as 25 million U.S. patients
in need.”
“The high statistical significance and clinically meaningful
outcomes in Saturn-2 and Saturn-1 demonstrate the impressive
ability of TP-03 to resolve Demodex blepharitis, a disease that has
long been without an effective, safe treatment option,” said
Elizabeth Yeu, M.D., Director and Chief Medical Advisor for Tarsus.
“We know that this disease has a significant impact on patients’
vision and their daily life, and that they often struggle for years
without relief. I am thrilled at the prospect of having TP-03
potentially available in the near future.”
Saturn-2 Topline Results
Saturn-2 is a Phase 3 randomized, controlled, double-masked
trial evaluating the efficacy and safety of TP-03 in patients with
Demodex blepharitis. The trial enrolled 412 adults having more than
10 collarettes per lid and at least mild lid erythema (redness).
Each patient also had at least 1.5 mites per lash. One drop of
TP-03 was self-administered twice per day in each eye for six
weeks. Enrolled patients received no treatment for blepharitis
(e.g., lid hygiene) during the trial or 14 days prior to
enrollment. Key topline results:
- Primary endpoint: Complete collarette cure,
defined as 0 to 2 collarettes per lid at day 43, was achieved by
56% of patients on TP-03, compared to 13% on vehicle (p<0.0001).
- Additionally, 89% of patients achieved a significant,
clinically meaningful collarette cure defined by a collarette grade
of zero (0) or one (1) at day 43 compared to 33% of those on
vehicle (p<0.0001).
- Secondary endpoints:
- Mite eradication: Defined as a mite density of
zero (0) mites per lash, was achieved by 52% of patients on TP-03
compared to 14% on vehicle (p<0.0001) at day 43.
- Complete lid erythema (redness)
cure: 31.1% of patients on TP-03 compared to 9.0% of
patients on vehicle (p<0.0001) achieved a complete lid erythema
cure at day 43.
- Complete composite cure:
19.2% of patients on TP-03 achieved a complete composite cure,
based on achieving both collarette cure and erythema cure, compared
to 4.0% on vehicle (p<0.0001) at day 43.
- Safety Profile: Consistent with Saturn-1,
Saturn-2 trial results demonstrated that TP-03 was well-tolerated
with a safety profile similar to the vehicle group.
- 91% of patients reported that the drop comfort was neutral to
very comfortable.
- There were no serious treatment-related adverse events. The
only adverse events occurring at a rate of ≥1% in the TP-03 group
were instillation site pain/burning/stinging (7.9%, n=16) and dry
eye (1.5%, n=3).
Webcast Information Tarsus will host a webcast
to discuss the results from the Saturn-2 Phase 3 trial today, May
2nd at 8:00 a.m. ET. The webcast can be accessed on the events
section of the Tarsus website. After the live webcast, the event
will remain archived on the Tarsus website at
https://ir.tarsusrx.com/ for 90 days.
About TP-03TP-03 (lotilaner ophthalmic
solution, 0.25%) is a novel, investigational therapeutic designed
to resolve the signs of Demodex blepharitis by targeting and
eradicating the root cause of the disease – Demodex mite
infestation. Lotilaner is a well-characterized anti-parasitic agent
that paralyzes and eradicates Demodex mites by selectively
inhibiting the GABA-Cl channels. It is a highly lipophilic
molecule, which may promote its uptake in the oily sebum of the
hair follicle where the mites reside. TP-03 was evaluated in two
pivotal trials collectively involving 833 patients. Both trials met
the primary and all secondary endpoints, with statistical
significance and no serious treatment-related adverse events. Both
trials also demonstrated that TP-03 was generally safe and
well-tolerated. If approved, TP-03 may offer treatment for millions
of patients with Demodex blepharitis.
About Demodex BlepharitisBlepharitis is a
common lid margin disease that is characterized by eyelid margin
inflammation, redness and ocular irritation. Demodex blepharitis is
caused by an infestation of Demodex mites, the most common
ectoparasite found on humans and accounts for over two-thirds of
all blepharitis cases. Demodex blepharitis may affect as many as 25
million Americans based on an extrapolation from the Titan study
indicating 58% of patients presenting to U.S. eye care clinics have
collarettes, a pathognomonic sign of Demodex infestation, and that
at least 45 million people annually visit an eye care clinic.
Demodex blepharitis can have a significant clinical burden and
negatively impact patients’ daily lives. The Titan study also
showed that current management tools, such as tea tree oil and lid
wipes, are ineffective at treating Demodex blepharitis. Currently,
there are no FDA-approved treatments for Demodex blepharitis.
About Tarsus Pharmaceuticals, Inc.Tarsus
Pharmaceuticals, Inc. applies proven science and new technology to
revolutionize treatment for patients, starting with eye care.
Tarsus 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. Tarsus is
studying two investigational medicines in clinical trials. Its lead
product candidate, TP-03, is a novel therapeutic which has
demonstrated positive results in two pivotal trials for the
treatment of Demodex blepharitis. TP-03 is also being developed for
the treatment of Meibomian Gland Disease. In addition, Tarsus is
developing TP-05, an oral, non-vaccine therapeutic for the
prevention of Lyme disease, which is currently being studied in a
Phase 1b clinical trial.
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 potential 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 trials including the
potential complete clinical results of the Saturn-2 trial,
anticipated regulatory and development milestones, the Company’s
cash balance at March 31, 2022 and the quotations of Tarsus’
management and board members. 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. 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, 2021 filed on March 14, 2022 with the SEC, 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:Adrienne KempSr.
Director, Corporate Communications(949)
922-0801akemp@tarsusrx.com
Investor Contact:David NakasoneHead of Investor Relations(949)
620-3223DNakasone@tarsusrx.com
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