- First patient first-dose achieved in the US in the second Phase 3 clinical trial
- Novel biologic treatment that aims to relieve inflammation, the primary cause of Dry Eye Disease
- To meet the needs of the ever-increasing number of DED patients due to ageing, use of smart phones, etc., it is crucial to develop different treatment options
HanAll Biopharma (KRX: 009420.KS) announced today that it has initiated dosing of HL036 (tanfanercept) in its second Phase 3 clinical trial (VELOS-3). HL036 is a novel biologic drug being co-developed with Daewoong Pharmaceutical in the US. It is noteworthy for its novel approach to treat the underlying causes such as inflammation of dry eye disease (DED) by inhibiting tumor necrosis factor (TNF) alpha, which plays an important role in inflammation.
In the first Phase 3 (VELOS-2), HL036 demonstrated statistically significant improvements in central corneal staining score (CCSS) and total corneal staining score (TCSS) compared to placebo. The VELOS-3 study will evaluate 300 patients with DED at 9 clinical sites in the US and mainly aims to replicate the improvement in CCSS.
Ageing is one of the main causes of DED, but with the excessive use of smart phones by the modern population as well as environmental factors such as air pollution, DED has become one of the most common ophthalmologic diseases. The size of the elderly population in particular is continuing to increase worldwide, so the number of patients is also projected to increase even more. DED patients with mild symptoms use over-the-counter treatments such as artificial tears, but they only provide temporary relief and fundamental treatment cannot be expected. Patients with severe symptoms tend to seek prescription medicines.
HL036 shows promise as a more fundamental treatment through a mechanism of action significantly strengthening the TNF neutralization ability by utilizing Resistein, HanAll Biopharma’s protein engineering technology. In addition, in the results of VELOS-2 announced last year, the level of discomfort was similar to that of artificial tears and the placebo treatment, providing hope to patients seeking dry eye medications that are comfortable to use.
The DED market is expected to grow quickly. According to the market research institute ResearchAndMarkets, the global DED market is anticipated to grow at a CAGR of 7% from 2020 through 2030 to over $6 billion. Moreover, Statista, a global market research institution, announced its findings that 117.45 million Americans, or 35% of the population, use artificial tears, indicating that the potential market could be huge for tanfanercept.
“HanAll Biopharma has dedicated the full extent of its clinical development capability for the VELOS-3 trial; it is expected to provide hope to patients around the world suffering from DED with the novel biologic treatment,” said Sean Jeong, M.D., Chief Executive Officer of HanAll Biopharma.
HL036 (INN: tanfanercept), jointly developed by HanAll Biopharma and Daewoong Pharmaceutical, is a novel, topical biologic treatment under development to treat inflammatory eye diseases by inhibiting TNF, which is involved in ocular inflammation. The first Phase 3 clinical trial (VELOS-2) for dry eye disease was completed in the U.S. last year. It is being developed in Phase 3 in China by Harbour BioMed, HanAll’s out-licensing partner for the greater China region.
The VELOS-3 study is a Phase 3, multicenter, randomized, double-blind, and placebo-controlled study evaluating the efficacy and safety of tanfanercept ophthalmic solution 0.25% compared to placebo in subjects with dry eye disease.
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