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 all pre-specified primary and secondary endpoints were met for
its pivotal Phase 2b/3 Saturn-1 trial evaluating the company’s
novel investigational therapeutic, TP-03 (lotilaner ophthalmic
solution, 0.25%), in patients with Demodex blepharitis. Results
demonstrated a statistically significant complete collarette cure
at day 43 in patients with Demodex blepharitis treated with TP-03
compared to vehicle (p<0.0001; primary endpoint). The Saturn-1
trial also met the secondary endpoints of mite eradication at day
43 (p<0.0001) and composite cure based on complete collarette
and erythema cures at day 43 (p<0.0001). In addition,
significant, clinically meaningful improvements were observed
within two weeks across multiple endpoints. TP-03 was well
tolerated with a safety profile similar to vehicle, and there were
no treatment-related discontinuations.
“Millions of people are living with Demodex blepharitis, and we
know from recent research that these patients are suffering daily.
With no U.S. Food and Drug Administration (FDA)-approved therapies,
both patients and eye care professionals need a solution to
eradicate the mites that cause the disease,” said Bobak Azamian,
M.D., Ph.D., President and Chief Executive Officer of Tarsus. “We
believe the results from our Saturn-1 trial mark an important
moment in Demodex blepharitis research, showing the potential of
TP-03 to target the underlying cause of this disease and
potentially become the standard of care for patients and
clinicians. We expect to provide topline results for our second
pivotal trial for TP-03, Saturn-2, in Q1 of 2022. If Saturn-2 trial
data is positive, similar to the positive Saturn-1 results, we
expect both Saturn-1 and Saturn-2 trials to support our submission
of a New Drug Application (NDA) for TP-03 for the treatment of
Demodex blepharitis in 2022.”
Demodex blepharitis is a highly prevalent ocular disease,
affecting as many as 25 million Americans, that can have a
significant clinical burden and negatively impact patients’ daily
lives. The disease is caused by an infestation of Demodex mites,
the most common ectoparasite found on humans, that live on the skin
of the face and eyelids. Demodex blepharitis is characterized by
inflammation of the eyelid margin, redness and ocular irritation.
TP-03 has the potential to be the first FDA-approved therapeutic
for Demodex blepharitis and targets the underlying cause of disease
– Demodex mite infestation. The Saturn-1 trial is the first
large-scale trial to show positive, clinically meaningful results
for a therapeutic specifically designed to treat Demodex
blepharitis.
Saturn-1 Phase 2b/3 Results
Results demonstrated 81% 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 23% of those on
vehicle (p<0.0001). Additionally, a significant, clinically
meaningful collarette cure was seen in 23% of patients on TP-03
compared to 11% on vehicle as early as day 8 (p=0.0003). Saturn-1
data also showed that 43% of patients on TP-03 achieved the primary
endpoint of complete collarette cure (grade 0) at day 43, defined
as zero to two (0-2) collarettes per lid compared to 7% on vehicle
(p<0.0001). Collarettes, a pathognomonic sign of Demodex
infestation, are composed of partially digested epithelial cells,
mite waste products and eggs and are most easily observed at the
base of the upper eyelashes when the patient looks down during a
standard eye examination.
The secondary endpoint of complete mite eradication achieved
statistically significant results by day 15, and 68% of patients on
TP-03 achieved mite eradication compared to 18% on vehicle
(p<0.0001) at day 43. Mite eradication is defined as a mite
density of zero (0) mites per lash.
For composite cure, 68% of patients experienced a significant,
clinically meaningful cure of both a grade zero (0) or one (1)
collarette and erythema score at day 43 compared to 20% on vehicle
(p<0.0001), with significant improvements seen as early as day
8. Additionally, 13.4% of patients on TP-03 achieved a complete
composite cure, which was another secondary endpoint, based on a
composite of collarette cure and erythema cure compared to 1.0% on
vehicle (p<0.0001) at day 43. Composite cure is defined as the
presence of zero to two (0-2) collarettes on the upper eyelid and
the absence of erythema (redness). Results for complete erythema
cure (19% of patients on TP-03 compared to 7% of patients on
vehicle, p<0.0001) and one (1) grade or more erythema
improvement (45% of patients on TP-03 compared to 28% of patients
on vehicle, p=0.0002) were also statistically significant.
Trial Safety Data
TP-03 is a well-characterized anti-parasitic agent that
paralyzes and eradicates Demodex mites by selectively inhibiting
parasite-specific GABA-Cl channels. Saturn-1 trial results
demonstrated that TP-03 was well tolerated with a safety profile
similar to the vehicle group. Additionally, most TP-03 patients
(92%) reported that the drop comfort was neutral to very
comfortable. There were no serious treatment-related adverse events
nor any treatment-related adverse events leading to treatment
discontinuation. All treatment-related ocular adverse events in the
TP-03 group were mild with the most common being instillation site
pain/burning/stinging (11.8%, n=25). Other adverse events occurring
at a rate of ≥1% in the TP-03 group included instillation site
pruritis, reduced visual acuity, eye pain and eye discharge, each
representing 1.4% (n=3) of patients.
Saturn-1 Phase 2b/3 Trial Design
Saturn-1 was a randomized, controlled, multicenter,
double-masked trial evaluating the safety and efficacy of TP-03 in
adults with Demodex blepharitis. The trial enrolled 421 adults aged
18 and over having more than 10 collarettes on the upper lid and at
least mild erythema of the upper eyelid margin. Each patient had at
least 1.5 mites per lash on the upper and lower eyelids combined.
One drop of TP-03 was self-administered twice per day in each eye
for six weeks and patients were instructed not to touch or rub
their lid margin. Enrolled patients received no treatment for
blepharitis symptoms (i.e., lid hygiene) during the trial or 14
days prior to enrollment.
“Demodex blepharitis is a widespread, yet frequently overlooked
condition that can negatively impact the quality of life for many
patients and lead to more serious health outcomes if left
untreated,” said Elizabeth Yeu, M.D., Chief Medical Advisor for
Tarsus. “I am highly encouraged by the results seen in the Saturn-1
trial and I’m hopeful that there may be a treatment option on the
horizon that targets the underlying cause of this disease to help
patients finally find relief.”
Tarsus is also evaluating TP-03 in its pivotal Saturn-2 (Phase
3) trial, which has the same endpoints as Saturn-1, and commenced
patient enrollment in May of 2021. Tarsus expects topline results
for the Saturn-2 trial in Q1 2022, and, if the results are
similarly positive, Tarsus expects data from both the Saturn-1 and
Saturn-2 trials to support submission of a New Drug Application
(NDA) to the FDA for TP-03 for the treatment of Demodex
blepharitis. TP-03 has the potential to help millions of patients
and eye care professionals struggling to manage Demodex
blepharitis.
Conference Call and Webcast Information
A detailed summary of the Saturn-1 findings will be presented on
a conference call and live, listen-only webcast today at 8:00 a.m.
ET. The dial-in numbers are (833) 540-1160 for domestic callers and
(929) 517-0351 for international callers. The Conference ID is
3766845. The webcast of the conference call can be accessed at
https://edge.media-server.com/mmc/p/uh6zebmu. After the live
webcast, the event will remain archived on the Tarsus
Pharmaceuticals 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 target and eradicate Demodex mites. TP-03 is a topical
ophthalmic formulation of lotilaner, which is a well-characterized
anti-parasitic agent that paralyzes and eradicates Demodex mites by
selectively inhibiting parasite-specific GABA-Cl channels. 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 was also evaluated in the pivotal
Saturn-1 (Phase 2b/3) trial and met all primary and secondary
endpoints with no serious treatment-related adverse events and no
treatment-related discontinuations. It is currently being evaluated
in the Saturn-2 (Phase 3) pivotal 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
U.S. 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. The company is
studying two investigational medicines in clinical trials. Its lead
product candidate, TP-03, is a novel therapeutic being studied in a
second Phase 3 pivotal trial for the treatment of Demodex
blepharitis. TP-03 is also being developed for the treatment of
Meibomian Gland Disease. Tarsus is developing TP-05, an oral,
non-vaccine therapeutic for the prevention of Lyme disease, which
is currently being studied in a Phase 1 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 includes statements regarding Tarsus’ plans for
and the anticipating benefits of its product candidates, including
TP-03, the timing, objectives and results of the clinical trials
and anticipated regulatory and development milestones, including
the timing of the Saturn-2 clinical trial and submission of an NDA,
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 eye
care 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 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 and Form 10-Q for the
quarter ended March 31, 2021 filed with the SEC on May 11, 2021,
which Tarsus incorporates by reference into this press release and
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
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/d788bb0e-ef21-4338-aa1d-dc7612611b81
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