Harbour BioMed (HBM) 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,” Prof. Xie said in a company news release. “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,” Jingsong Wang, MD, PhD, Chairman and CEO of HBM, said in the news release. “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.”