HanAll Launches Phase III VELOS-4 Trial for Dry Eye Treatment with Tanfanercept

Global pharmaceutical firm HanAll Biopharma has embarked on a Phase III clinical trial, VELOS-4, to assess the efficacy and safety of a new topical anti-inflammatory drug, tanfanercept, for the treatment of moderate to severe dry eye disease (DED). This advancement follows the positive results from the prior Phase III VELOS-3 study, where tanfanercept showed a significant increase in tear volume as measured by Schirmer testing.

Dry eye disease is a prevalent chronic condition, affecting an estimated 14.5% of the US population, and current treatments often fail to adequately manage symptoms, leading to visual impairment and inflammation. There is a significant need for new treatments that can address the underlying mechanisms of the disease.

Tanfanercept, developed in collaboration with Daewoong Pharmaceutical, is designed to target tumor necrosis factor (TNF), a key cytokine involved in the inflammation associated with DED. It is a specially engineered fragment of the tumor necrosis factor receptor 1 (TNFR1) with a high affinity for TNF and enhanced stability against degradation.

The VELOS-4 trial builds upon the insights gained from the VELOS-3 study, which demonstrated a significant improvement in tear volume for patients treated with tanfanercept at week 8. The FDA has recognized a minimum 10mm increase in the Schirmer test response rate as a valid primary efficacy endpoint for dry eye drug approval.

HanAll Biopharma's CEO, Sean Jeong, expressed optimism about the potential of tanfanercept to provide relief for those suffering from DED, citing its innovative approach and promising early study results. The company anticipates the release of the top-line data from the VELOS-4 trial in the latter part of 2025.

The VELOS-4 study is a randomized, double-masked, vehicle-controlled trial conducted at multiple centers in the US. It will evaluate the twice-daily application of tanfanercept ophthalmic solution at concentrations of 0.25% and 1.0% in adults with DED, comparing the results to a vehicle control. The primary measure of efficacy will be the proportion of patients showing an improvement of 10mm or more in the unanesthetized Schirmer test by day 85.

HanAll Biopharma, listed on the KRX with the ticker 009420.KS, has a mission to develop impactful medicines for severe unmet medical needs and has been in operation for over five decades. The company has expanded into various therapeutic areas, including immunology, oncology, neurology, and ophthalmology, with a focus on creating innovative treatments for diseases lacking effective options.

In addition to tanfanercept, HanAll Biopharma is also developing other promising assets such as HL161 (batoclimab), an anti-FcRn antibody for autoimmune diseases, and HL192 (ATH-399A), a Nurr1 activator for Parkinson's Disease, which are in various stages of clinical trials.