LianBio Partner Tarsus Pharmaceuticals Announces U.S. FDA Approval of XDEMVY™ (lotilaner ophthalmic solution) 0.25% for the Treatment of Demodex Blepharitis
26 Luglio 2023 - 2:30PM
LianBio’s (Nasdaq: LIAN) partner, Tarsus Pharmaceuticals (Tarsus),
announced yesterday that the U.S. Food and Drug Administration
(FDA) approved XDEMVY™ (lotlilaner ophthalmic solution) 0.25% for
the treatment of Demodex blepharitis. XDEMVY, formerly known as
TP-03, is the first and only FDA approved treatment to directly
target Demodex mites, the root cause of Demodex blepharitis.
LianBio in-licensed rights from Tarsus for the development and
commercialization of TP-03 for Demodex blepharitis and Meibomian
Gland Disease in Mainland China, Hong Kong, Macau and Taiwan.
LianBio is currently conducting the LIBRA trial, a Phase 3
multicenter, double-blind, randomized, vehicle-controlled
registrational study designed to evaluate the efficacy and safety
of TP-03 in Chinese adult patients with Demodex blepharitis, with
an open-label pharmacokinetics sub-study. LIBRA completed
enrollment of 163 patients in June 2023. The co-primary endpoints
are complete collarette cure (collarette score of 0) and mite
eradication (mite density of 0 mites per lash) at day 43. Secondary
endpoints include composite cure of collarette and erythema
(collarette score of 0 and erythema score of 0) at day 43. LianBio
expects to report topline results from LIBRA in the fourth quarter
of 2023. More information about the LIBRA trial can be found on
http://www.chinadrugtrials.org.cn/index.html (CTR20220726) and
http://www.clinicaltrials.gov (NCT05629390).
"We congratulate Tarsus on receiving U.S. FDA approval of XDEMVY
for the treatment of Demodex blepharitis,” said Yizhe Wang, Ph.D.,
Chief Executive Officer of LianBio. “XDEMVY is the only approved
drug in the United States that targets the root cause of Demodex
blepharitis, a disease that impacts an estimated 43 million
patients in China. We look forward to concluding our LIBRA study
this year, and if the data are positive, submitting a New Drug
Application to support regulatory approval in China.”
About Demodex
Blepharitis Blepharitis is a common lid margin
disease that is characterized by eyelid margin inflammation,
redness and ocular irritation which not only causes ocular
discomfort but can have an adverse effect on quality of life.
Demodex blepharitis is caused by an infestation of Demodex mites,
the most common ectoparasite found on humans which accounts for
over two-thirds of all blepharitis cases. Demodex blepharitis may
affect as many as 40 million people in China.
About XDEMVY™XDEMVY (lotilaner ophthalmic
solution) 0.25%, formerly known as TP-03, is a novel prescription
eye drop designed to treat Demodex blepharitis by targeting and
eradicating the root cause of the disease – Demodex mite
infestation. The active ingredient in XDEMVY is lotilaner, which is
a well-characterized agent that eradicates Demodex mites by
selectively inhibiting the mite’s GABA-Cl channels. It is a highly
lipophilic molecule, which may promote its uptake in the oily sebum
of the eye lash follicles where the mites reside. XDEMVY was
evaluated in two pivotal trials conducted by Tarsus Pharmaceuticals
in the United States collectively involving more than 800 patients.
Both trials met the primary endpoint and all secondary endpoints,
with statistical significance and no serious treatment-related
adverse events. Most patients found the XDEMVY eye drop to be
neutral to very comfortable. The most common ocular adverse
reactions observed in the studies were instillation site stinging
and burning which was reported in 10% of patients. Other ocular
adverse reactions reported by less than 2% of patients were
chalazion/hordeolum (stye) and punctate keratitis.
About LianBioLianBio is a cross-border
biotechnology company on a mission to bring transformative
medicines to historically underserved patients in China and other
Asian markets. Through partnerships with highly innovative
biopharmaceutical companies around the world, LianBio is advancing
a diversified portfolio of clinically validated product candidates
with the potential to drive new standards of care across
cardiovascular, oncology, ophthalmology, and inflammatory disease
indications. LianBio is establishing an international
infrastructure to position the company as a partner of choice with
a platform to provide access to China and other Asian markets. For
more information, please visit www.lianbio.com.
Cautionary Note Regarding 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. The words “estimate,” “potential,”
“expect,” “may,” and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Forward-looking
statements in this press release include, but are not limited to,
statements concerning the potential of TP-03 to target the root
cause of Demodex blepharitis, the Company’s plans and expectations
with respect to its ability to develop and bring XDEMVY to patients
in China, the potential for the LIBRA trial to support registration
of XDEMVY in China, and the Company’s plans and expectations with
respect to the timing of reporting topline results from the LIBRA
clinical trial of XDEMVY in China. Actual results may differ
materially from those indicated by such forward-looking statements
as a result of various important factors, including: the Company’s
ability to successfully conduct its planned clinical trials and
complete such clinical trials and obtain results on its expected
timelines, or at all; competition from other biotechnology and
pharmaceutical companies; general market conditions; the impact of
changing laws and regulations and those risks and uncertainties
described in LianBio’s filings with the U.S. Securities and
Exchange Commission (SEC), including LianBio’s Annual Report on
Form 10-K for the year ended December 31, 2022 and subsequent
filings with the SEC. Any forward-looking statements contained in
this press release speak only as of the date hereof, and LianBio
specifically disclaims any obligation to update any forward-looking
statement, whether as a result of new information, future events or
otherwise. Readers should not rely upon this information as current
or accurate after its publication date.
For investor inquiries, please contact:
Elizabeth Anderson, VP Communications and Investor
Relations E:
elizabeth.anderson@lianbio.com T: +1 646 655
8390
For media inquiries, please contact:
Josh Xu, Director of Communications
E: josh.xu@lianbio.com T: +86 136
6140 8315
Katherine Smith, Evoke Canale
E: katherine.smith@evokegroup.com
T: +1 619 849 5378
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