HANALL BIOPHARMA

-      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.

 

About HL036 and VELOS-3

 

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.

 

About HanAll Biopharma Co., Ltd.

 

HanAll Biopharma (KRX: 009420.KS) is a global biopharmaceutical company founded in 1973 with a mission of making meaningful contributions to patients’ lives by introducing innovative, impactful therapies to address severe unmet medical needs. HanAll has been operating a portfolio of pharmaceutical products in areas of endocrine, circulatory, and urologic diseases for more than 48 years. HanAll is now focused on autoimmune disease, ophthalmology, oncology, and neurology to discover and develop innovative medicines for patients with diseases for which there are no effective treatments. Its leading pipeline asset, HL161 (INN: batoclimab), an anti-FcRn antibody drug, is in Phase 3 and Phase 2 trials across the world for the treatment of rare autoimmune disorders. Another main asset, HL036 (INN: tanfanercept), an anti-TNF alpha protein drug, is in Phase 3 clinical trials in the US and China for the treatment of dry eye disease.

 

For further information, please contact: 

​

HanAll IR team (ir@hanall.co.kr) or

Daewoong IR team (t_797rx@daewoong.co.kr)

 

Forward-looking Statements

 

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outlook and related plans; the therapeutic potential of its product candidates; the intended results of its strategy and the company, and its collaboration partners’, advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and expected data readouts; the design of future clinical trials and the timing and outcome of regulatory filings and regulatory approvals. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The company’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including the effects of the COVID-19 pandemic, our expectations regarding its the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities and regulatory approval requirements; our reliance on collaborations with third parties; estimating the commercial potential of our product candidates; our ability to obtain and maintain protection of intellectual property for its technologies and drugs; our limited operating history; and our ability to obtain additional funding for operations and to complete the development and commercialization of its product candidates. A further list and description of these risks, uncertainties and other risks can be found in Korea Stock Exchange (KRX) filings and reports, including in our most recent annual report as well as subsequent filings and reports filed by the company with the KRX. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. We undertake no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by Korean law and regulations.