Tanfanercept Phase III Trial for Dry Eye Disease Fails to Meet Primary Endpoint; Harbour BioMed Terminates China Development

On May 19, HanAll Biopharma announced the results of the Phase III VELOS-3 study of Tanfanercept for the treatment of patients with moderate to severe dry eye disease (DED): At week 8, the improvement in central corneal staining score (CCSS) or dry eye score (EDS) in the Tanfanercept treatment group did not show statistical significance, failing to meet the primary endpoint.

VELOS - 3 (NCT05109702) is a U.S. multi-center, randomized, double-blind, placebo-controlled Phase III study designed to evaluate the safety and efficacy of 0.25% Tanfanercept in adult patients with moderate to severe DED.

Despite not reaching the primary endpoint, Tanfanercept achieved a secondary endpoint with a highly statistically significant improvement in the Schirmer test. At week 8, 15% of patients in the Tanfanercept group showed an improvement of 10mm from baseline, compared to only 4% in the control group (p<0.001). Overall, Tanfanercept was well-tolerated, and its safety profile was consistent with the results from the previous Phase II VELOS-1 and Phase III VELOS-2 studies.

HanAll stated that it will continue to review the data from the VELOS-3 study as well as all aggregated data regarding Tanfanercept research to refine the design of the next study.

Tanfanercept is a novel, potential first-in-class anti-inflammatory DED therapy targeting Tumor Necrosis Factor-α (TNF-α). TNF is the primary cytokine mediating DED inflammation. As a TNF receptor fragment, Tanfanercept has a strong affinity for TNF and can be used to alleviate and improve dry eye symptoms.

In September 2017, Harbour BioMed acquired the rights for the development, manufacturing, and commercialization of Tanfanercept (HBM9036) in Greater China. In October 2022, based on observed trends of insufficient efficacy, Harbour BioMed announced the termination of the Phase III clinical trial of HBM9036 in China, with no new participants to be enrolled, but will continue follow-up for existing participants according to the clinical trial protocol (see: ).

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