18 October 2019 - - US-based biopharmaceutical company Harbour BioMed has completed 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, the company said.

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 and 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 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.

More than 300m 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 m 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.

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.

Harbour BioMed is a global, clinical stage biopharmaceutical company developing innovative therapeutics in the fields of immuno-oncology and inflammatory diseases.