HanAll Biopharma has failed to demonstrate statistical significance for either of the two primary efficacy endpoints in the Phase III VELOS-3 clinical trial of tanfanercept 0.25% for the treatment of dry eye disease (DED).
The double-masked, vehicle-controlled, multicentre, randomised study in the US has assessed the efficacy and safety of tanfanercept in subjects with moderate-to-severe DED.
The primary efficacy endpoint measuring improvement from baseline in the central corneal staining score (CCSS) was not met in the week-eight study of tanfanercept against vehicle.
Other endpoints measuring improvement from baseline in Eye Dryness Score via Visual Analogue Scale (VAS) assessed at the same period in subjects with DED against vehicle were also not met in the study.
However, the study met the secondary efficacy endpoint of unanesthesised Schirmer testing with statistically significant improvement (p<0.001) to quantify change from baseline in tear volume in tanfanercept treatment group against the vehicle, as evaluated at week eight.
Previous Phase III VELOS-2 study’s post hoc analysis data from Schirmer testing also met statistical significance (p<0.05) of improvement in tanfanercept-treated group against vehicle.
Safety findings from the VELOS-3 study were found to be consistent in comparison to previous studies with no significant new adverse events observed.
HanAll Biopharma CEO Sean Jeong said: “The analyses of the Schirmer results for both Phase III trials are highly encouraging for the impact it may have for dry eye disease patients and provides a compelling rationale for further development of tanfanercept.
“HanAll intends to continue its evaluation of tanfanercept, and our future clinical programme will build on the important learnings from the past three studies.
“Also, HanAll is exploring tanfanercept’s further potential at higher concentrations as well as additional indications. We are planning the next study design within 2H2023 and intend to discuss the VELOS-3 data and future plans with the FDA at the earliest opportunity.”