HanAll Biopharma Co., Ltd. released results from the phase 3 VELOS-3 trial assessing the safety and efficacy of HL036 (tanfanercept 0.25%) for the treatment of moderate to severe dry eye disease (DED).
Give me some background on the company.
HanAll Biopharma is a global biopharmaceutical company based in Seoul, South Korea, focused on operating a product portfolio for endocrine, circulatory, and urologic diseases—as well as in areas such as ophthalmology, immunology, oncology, and neurology—for developing medicines to treat diseases with no current treatment.
HL161 (batoclimab) is the company’s lead candidate for autoimmune diseases such as thyroid eye disease (TED); HL036 (tanfanercept), is currently under investigation in clinical trials within the U.S. and China for DED.
Now talk about tanfanercept.
Co-developed with South Korea-based Daewoong Pharmaceutical, tanfanercept is a novel, potentially first-in-class, topical anti-inflammatory tumor necrosis factor alpha (TNF-α) inhibitor protein and molecularly-engineered TNF receptor 1 (TNFR1) that uses proteinases to resist degradation.
To note, TNF-α is known to be a major cytokine that regulates inflammatory responses associated with DED.
And this phase 3 trial?
The multicenter, randomized, double-masked, placebo-controlled phase 3 VELOS-3 study (NCT05109702) enrolled 260 patients (ages 18+) diagnosed with DED at least 6 months prior to the trial’s start. See here for details on inclusion criteria.
Patients self-administered either a 0.25% dose of tanfanercept or a placebo, twice a day for 8 weeks.
What were the primary endpoints?
The VELOS-3 trial set out to investigate primary efficacy endpoints including improvement from baseline in central corneal staining score (CCSS) and from baseline in Eye Dryness Score via Visual Analog Scale (VAS) at week 8.
And the findings?
The company reported that tanfanercept did not demonstrate a statistical significance for both primary efficacy endpoints.
However, the drug candidate did meet its secondary objectives, which included a statistically significant improvement in Schirmer testing of tear volume from baseline to week 8.
Any other positive data?
The proportion of patients whose Schirmer test improved from baseline by 10 mm or more (evaluated at week 8) was statistically significant (p < 0.001) for tanfanercept-treated patients (15%) versus placebo (4%).
How did this data compare to prior trials?
The latest findings are consistent with data from the phase 3 VELOS-2 study (NCT03846453), where tanfanercept-treated patients also exhibited statistically significant improvement (p < 0.05) for Schirmer testing from baseline to week 8.
Similarly, no significant adverse events were observed.
And what does it mean for the future of tanfanercept?
HanAll noted that the FDA’s 2020 guidelines for dry eye drug development indicates a statistically significant difference between the patient percentage achieving a 10 mm or more increase in Schirmer’s tear test scores is considered an acceptable replacement for primary efficacy endpoints.
So what’s next?
According to HanAll CEO Sean Jeong, MD, MBA, the company plans to continue evaluating tanfanercept at higher concentrations and 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,” he stated.