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Successful completion of Phase 2 monotherapy trial paves way for Phase 3 trials in China in early 2020

CAMBRIDGE, Mass. & ROTTERDAM, The Netherlands & SHANGHAI–(BUSINESS WIRE)–Sixth paragraph, second sentence should read: “DED is more prevalent in Asia; over 100 million people in China are estimated to be affected by DED.” (instead of “DED is more prevalent in Asia and over 30 percent of the Chinese population are estimated to be affected by DED.)

Harbour BioMed announces completion of Phase 2 study in China of HBM9036 in patients with moderate-to-severe dry eye disease, paving way for Phase 3 trials in early 2020

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HARBOUR BIOMED ANNOUNCES COMPLETION OF PHASE 2 STUDY IN CHINA OF HBM9036 IN PATIENTS WITH MODERATE-TO-SEVERE DRY EYE DISEASE

Successful completion of Phase 2 monotherapy trial paves way for Phase 3 trials in China in early 2020

Harbour BioMed (HBM) today announced completion of a Phase 2 study in China of HBM9036 (tanfanercept), a new, investigational TNF receptor-1 fragment, in adult patients with moderate-to-severe Dry-Eye-Disease (DED). The study results, combined with previous results from HBM’s partner HanAll’s clinical trials, position the product to begin phase 3 studies in China in early 2020.

The study was designed to compare the safety & efficacy of tanfanercept to a previously conducted Phase 2 study (VELOS-1) in the US by HanAll, the results of which were presented at The Association for Research in Vision and Ophthalmology (ARVO) 2019. In the HBM study, 100 patients were randomized to receive 0.25% HBM9036 or vehicle control, administered as eye drops, to moderate-to-severe DED patients, twice a day for 8 weeks. The study, conducted at Qingdao Eye Hospital of Shandong Eye Institute, was led by Prof. Lixin Xie, a prominent ophthalmologist in the field of ophthalmic diseases and member of the Chinese Academy of Engineering in China.

The study results were consistent with the previous Phase 2 trial (VELOS-1) that showed significant improvements in signs as measured by Corneal Staining Score, a measure of corneal damage. HBM9036 was generally safe and well tolerated with a similar comfort level as the vehicle control. More detailed results will be presented at upcoming international medical meetings.

“Dry eye disease is a complex and often underdiagnosed disease that has a significant impact on patient lives. Recent studies have indicated an increase in the incidence of this condition fueled by a global increase in aging population, increased use of smartphones, and higher levels of micro-dust in the environment. Artificial tears, the most commonly used treatment in China, only provide symptomatic relief. Blocking inflammation with TNFR1 directly in the eye may provide a novel approach for this serious condition,” said Prof. Xie. “The learnings from this study will enable us to design a robust Phase 3 trial and bring much needed relief to Chinese patients with DED.”

“HBM9036 is the first and most advanced biologic approach for DED in China that addresses the underlying inflammation responsible for the progression of the disease. The robust improvement in signs accompanied by a favorable safety profile further paves the way for a Phase 3 clinical trial in China which we anticipate beginning in early 2020,” said Dr. Jingsong Wang, M.D., Ph.D., Chairman and CEO of HBM. “With the increasing burden and impact of DED on our society, we are excited to work with the Chinese medical community to develop this novel therapy addressing unmet patients’ needs.”

About Dry Eye Disease
More than 300 million people experience dry eye disease worldwide, but only one-fifth of those receive medical care, owing to the undiagnosed and/or under-diagnosed patient population. DED is more prevalent in Asia; over 100 million people in China are estimated to be affected by DED. In contrast, fewer options for Chinese patients are available, with the most commonly used drugs being artificial tears, to provide temporary relief on symptoms. Over the next decade, the incidence and severity is expected to grow exponentially, aided by better tools to effectively diagnose DED, and fueled by a growing aging population worldwide, excessive use of smartphones and environmental changes, including micro-dust.

About HBM9036 (tanfanercept)
HBM9036 for the treatment of DED is a biopharmaceutical drug developed by our global partner HanAll BioPharma Co., Ltd. Tanfanercept is a molecularly engineered TNF receptor 1 fragment, as a therapy for relief of the signs and symptoms of dry eye. HL036 was specifically developed for ophthalmic topical use with tissue distribution, stability, and potency optimized for treatment of dry eye disease. HBM licensed the rights to develop, manufacture and commercialize tanfanercept as HBM9036 in Greater China. Tanfanercept is concurrently being studied in a global Phase 3 trial (VELOS-2) by HanAll. HBM9036 is the first global innovative biologic in clinical development for the treatment of DED in China.

About Harbour BioMed
Harbour BioMed is a global, clinical stage biopharmaceutical company developing innovative therapeutics in the fields of immuno-oncology and inflammatory diseases. The company is building its proprietary pipeline through internal R&D programs, collaborations with co-discovery and co-development partners and select acquisitions. The company’s discovery and development programs are centered around its two patented transgenic mouse platforms for generating fully human monoclonal antibodies. Harbour BioMed also licenses the platforms to companies and academic institutions. The company has operations in Cambridge, Massachusetts; Rotterdam, The Netherlands; and Shanghai, China. For more information, visit www.harbourbiomed.com.

Contacts

Media and Investor Relations:
Atul Deshpande, Ph.D., MBA
Chief Strategy Officer and Head, US Ops.
Phone: +1-908-210-3347
E-mail: atul.deshpande@harbourbiomed.com

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