Clinical Trials Arena

HanAll Biopharma initiates Phase III DED treatment trial

The trial will assess the efficacy and safety of tanfanercept ophthalmic solution given twice daily.

HanAll Biopharma has commenced the Phase III VELOS-4 trial for tanfanercept, a new topical anti-inflammatory treatment for moderate to severe dry eye disease (DED).

The trial marks a significant step in the development of tanfanercept, which targets tumour necrosis factor (TNF) and is jointly developed with Daewoong Pharmaceutical.

The US-based multicentre, double-masked, randomised, and vehicle-controlled trial will assess the efficacy and safety of tanfanercept ophthalmic solution, administered twice a day daily at concentrations of 0.25% and 1.0% versus vehicle.

It will enrol adult patients with moderate to severe DED.

The proportion of subjects who achieve a 10mm or greater improvement from baseline in the unanaesthetised Schirmer test by day 85 will also be assessed in the trial.

HanAll anticipates top-line data from the VELOS-4 trial in the second half of next year.

The latest trial builds upon insights from the completed VELOS-3 study, which demonstrated a statistically significant improvement in tear volume among people treated with tanfanercept.

In VELOS-3, tanfanercept showed to improve tear volume as assessed by unanaesthetised Schirmer testing in the group of subjects treated with tanfanercept versus the vehicle group at week eight.

Additionally, a post hoc analysis of the VELOS-3 data indicated that 13% of participants in the tanfanercept group had a Schirmer test improvement of at least 10mm from baseline at week eight.

The VELOS-2 study, which preceded VELOS-3, also showed consistent improvement in Schirmer test results, reinforcing the potential of tanfanercept as a treatment for DED.

HanAll Biopharma CEO Sean Jeong said: “Initiating the Phase III VELOS-4 trial marks a significant milestone in our commitment to addressing the unmet needs of patients suffering from dry eye disease.

“With tanfanercept's promising results in earlier studies and its innovative mechanism targeting TNF, we are hopeful that this novel treatment will offer new hope and relief to those affected by this debilitating condition.”