LianBio Announces Topline Results from Phase 3 LIBRA Trial of TP-03 in Chinese Patients with Demodex Blepharitis
October 30 2023 - 4:05PM
LianBio (Nasdaq: LIAN), a biotechnology company dedicated to
bringing innovative medicines to patients in China and other major
Asian markets, today announced topline results from the Phase 3
LIBRA clinical trial evaluating TP-03 in Chinese patients with
Demodex blepharitis.
The co-primary endpoints of the LIBRA trial were mite
eradication (mite density of 0 mites per lash) and complete
collarette cure (collarette score of 0) at day 43. Results
demonstrated statistically significant mite eradication in patients
with Demodex blepharitis treated with TP-03 compared to vehicle
(p<0.001). A positive, but not statistically significant trend
(p=0.15) was also observed for complete collarette cure. TP-03 was
well tolerated with a safety profile similar to that observed in
other large-scale clinical trials, and there were no
treatment-related discontinuations.
LianBio plans to discuss these results with the China National
Medical Products Administration (NMPA) and expects to use these
data to support a New Drug Application filing in China.
“Demodex blepharitis patients often experience significant
impacts to their daily activities, and there are currently no
approved medicines in China that eradicate the root cause of
disease – the Demodex mite,” said Professor Zuguo Liu, M.D., Ph.D.,
Director of Xiamen Eye Center of Xiamen University, Principal
Investigator of the LIBRA study. “I am highly encouraged by the
results of the LIBRA trial, which demonstrate TP-03’s ability to
drive statistically and clinically significant mite eradication in
Chinese patients with Demodex blepharitis.”
“We are pleased that the LIBRA trial demonstrated significant
Demodex mite eradication, the primary etiology of Demodex
blepharitis, as well as a favorable safety profile. This is the
first Demodex-specific therapy that treats the underlying cause of
the disease, and we believe these data provide a foundation for
pursuing regulatory approval in China,” said Yizhe Wang, Ph.D.,
Chief Executive Officer of LianBio. “We look forward to gaining a
deeper understanding of how Demodex blepharitis impacts collarettes
in Chinese patients and working with the ophthalmic community and
regulatory authorities to make this therapy available to patients
in China.”
LIBRA is a Phase 3 multicenter, double-blind, randomized,
vehicle-controlled registrational study that evaluated the efficacy
and safety of TP-03 in Chinese adult patients with Demodex
blepharitis, with an open-label pharmacokinetics sub-study. More
information about the LIBRA trial can be found on
http://www.chinadrugtrials.org.cn/index.html (CTR20220726) and
http://www.clinicaltrials.gov (NCT05629390).
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
NMPA for Demodex blepharitis.
About TP-03TP-03 is a novel prescription eye
drop for the treatment of Demodex blepharitis and is designed to
target and eradicate the root cause of the disease – Demodex mite
infestation. It is marketed in the U.S. under the brand name
XDEMVY® (lotilaner ophthalmic solution) 0.25%. The active
ingredient in TP-03 is lotilaner, 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 eyelash 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. Most patients found TP-03 to be neutral to very
comfortable. The most common ocular adverse reactions observed in
the studies were 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.
LianBio in-licensed rights from Tarsus Pharmaceuticals for the
development and commercialization of TP-03 in Mainland China, Hong
Kong, Macau and Taiwan.
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 “plans,” “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 regarding LianBio’s plans to discuss the data from the
LIBRA trial with the NMPA and to use these data to support a New
Drug Application in China, and LianBio’s expectations that it will
gain a greater understanding of how Demodex blepharitis impacts
collarettes in Chinese patients and work with the ophthalmic
community and regulatory authorities to make TP-03 available to
patients 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.comT:
+1 646 655 8390
For media inquiries, please contact:
Josh Xu, Director of Communications
E: josh.xu@lianbio.comT: +86
136 6140 8315
Katherine Smith, Evoke Canale
E: katherine.smith@evokegroup.comT:
+1 619 849 5378
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