LianBio Completes Enrollment in Pivotal Phase 3 LIBRA Trial of TP-03 in Chinese Patients with Demodex Blepharitis

•  LIBRA trial designed to support registration of TP-03 in China
•  Topline results expected in the fourth quarter of 2023

SHANGHAI, China and PRINCETON, N.J., June 08, 2023 (GLOBE NEWSWIRE) -- 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-03
TP-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 LianBio
LianBio 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