LianBio Completes Enrollment in Pivotal Phase 3 LIBRA Trial of TP-03 in Chinese Patients with Demodex Blepharitis
June 08 2023 - 7:00AM
LianBio (Nasdaq: LIAN), a biotechnology company dedicated to
bringing innovative medicines to patients in China and other major
Asian markets, today announced the completion of enrollment in the
Phase 3 LIBRA clinical trial of TP-03 in Chinese patients with
Demodex blepharitis.
“LianBio is committed to bringing a safe and effective treatment
option to the tens of millions of patients living with Demodex
blepharitis in China,” said Yizhe Wang, Ph.D., Chief Executive
Officer of LianBio. “Although patients with Demodex blepharitis
experience significant impact to quality of life, today there are
no available treatments that address the underlying cause of their
disease. We thank the participants in the LIBRA study and look
forward to reporting topline data in the fourth quarter of
2023.”
TP-03 is a novel investigational therapeutic designed to resolve
the signs and symptoms of Demodex blepharitis by targeting and
eradicating the root cause of the disease – Demodex mite
infestation. Blepharitis is a disease characterized by inflammation
of the eyelid margins. Patients with Demodex blepharitis often
experience red and watery eyes, burning or stinging in the eyes,
itchy, red, and/or swollen eyelids, and crustiness around the
eyelashes which impacts quality of life. Lotilaner, the active
ingredient in TP-03, is a well-characterized agent that eradicates
Demodex mites by selectively inhibiting the GABA-Cl channels. In
two pivotal Phase 3 studies of TP-03 conducted in the United States
by LianBio’s partner Tarsus Pharmaceuticals, Inc. (Tarsus), TP-03
met all primary and secondary endpoints, effectively resolving
Demodex blepharitis, and was well tolerated.
LianBio in-licensed rights from Tarsus for the development and
commercialization of TP-03 in Mainland China, Hong Kong, Macau and
Taiwan.
LIBRA is 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
enrolled 163 patients. 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. More information about the
LIBRA trial can be found on
http://www.chinadrugtrials.org.cn/index.html (CTR20220726) and
http://www.clinicaltrials.gov (NCT05629390).
LianBio expects to report topline results from the LIBRA trial
in the fourth quarter of 2023.
About Demodex
Blepharitis Blepharitis 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 69%
of blepharitis. Currently, there are no treatments approved by the
FDA or China National Medical Products Administration for Demodex
blepharitis.
About TP-03TP-03 (lotilaner
ophthalmic solution, 0.25%) is a novel, investigational therapeutic
designed to resolve the signs and symptoms of Demodex blepharitis
by targeting and eradicating the root cause of the disease –
Demodex mite infestation. Lotilaner is a well-characterized agent
that 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 eye lash follicles where the mites
reside. TP-03 was evaluated in two pivotal trials 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. Both trials also demonstrated that TP-03 was
well-tolerated. The most common treatment related ocular adverse
event occurring at a frequency of >2% in TP-03 treated patients
was instillation site pain/burning/stinging. All of these adverse
events were either mild or moderate. If approved, TP-03 may offer
treatment for millions of patients with Demodex blepharitis. TP-03
is now also being studied for the treatment of Meibomian Gland
Disease in patients with Demodex mites.
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 resolve the signs
and symptoms of Demodex blepharitis, the Company’s plans and
expectations with respect to its ability to develop and bring TP-03
to patients in China, the potential for the LIBRA trial to support
registration of TP-03 in the Company’s licensed territories, and
the Company’s plans and expectations with respect to the timing of
reporting topline results from the LIBRA clinical trial of TP-03 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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