• HanAll has initiated a Phase III VELOS-4 study to evaluate the efficacy and safety of tanfanercept in dry eye based on the findings from the previous Phase III VELOS-3 study.
• Tanfanercept demonstrated statistically significant improvement on the secondary outcome measure, Schirmer testing of tear volume, from the previous Phase III study.
• The top-line data for the Phase III VELOS-4 study is expected in the second half of 2025.

ROCKVILLE, Md. and SEOUL, South Korea, May 3, 2024 /PRNewswire/ -- HanAll Biopharma Co., Ltd. (KRX: 009420. KS), a global biopharmaceutical company committed to discovering and developing innovative medicines for patients, announced the initiation of a Phase III VELOS-4 trial evaluating the efficacy and safety of tanfanercept, a novel, topical anti-inflammatory treatment in participants with moderate to severe dry eye disease (DED).

Dry eye disease is a chronic multifactorial disease with a prevalence estimation of 14.5% for the US population^([1]). The available treatments for DED often prove insufficient in managing symptoms, occasionally resulting in visual impairment and ocular inflammation, alongside a low response rate that contributes to discontinuation. Thus, there is an unmet clinical need to develop mechanism-based and disease-modifying treatments.

Tanfanercept is a potentially first-in-class topical anti-inflammatory treatment targeting tumor necrosis factor (TNF) for the treatment of DED, co-developed with Daewoong Pharmaceutical. TNF is a major cytokine mediating inflammation in DED. Tanfanercept is a molecularly engineered tumor necrosis factor receptor 1 (TNFR1) fragment with strong affinity for TNF and resistance to degradation by proteinases.

The Phase III VELOS-4 trial leverages key insights from the concluded Phase III VELOS-3 study. In VELOS-3, tanfanercept showed a statistically significant improvement in the secondary efficacy endpoint of tear volume measured by unanesthesized Schirmer testing in the group of patients treated with tanfanercept compared to the vehicle group at week 8 (p=0.002). Furthermore, a post hoc analysis revealed that a noteworthy proportion of participants in the tanfanercept group (13%) exhibited a Schirmer test improvement of at least 10mm from baseline at week 8, which was also statistically significant (p=0.011) compared to the vehicle group (4%). VELOS-2, a preceding Phase III study, also demonstrated a consistent improvement in Schirmer testing in an ad hoc analysis that subset the population to be similar to that of patients studied in VELOS-3.

The 2020 FDA Draft Guidance on Dry Eye Drug Development includes the proportion of participants with a minimum 10mm increase in the Schirmer test response rate as an acceptable primary efficacy endpoint for approval.

"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," said Sean Jeong, M.D., MBA, CEO of HanAll Biopharma.

Top-line data from the Phase III VELOS-4 trial is anticipated in the second half of 2025.

About VELOS-4

VELOS-4 is a US-based multicenter, randomized, double-masked, vehicle-controlled Phase III study to evaluate the efficacy and safety of twice-daily tanfanercept ophthalmic solution (0.25%, 1.0%) for the treatment of adults with moderate to severe DED compared to vehicle. The study assesses the proportion of patients who have shown 10mm or more improvement from baseline in an unanesthetized Schirmer test at day 85.

About VELOS-3

VELOS-3 (NCT05109702) is a US-based multicenter, randomized, double-masked, vehicle-controlled Phase III study designed to evaluate the safety and efficacy of twice-daily tanfanercept (0.25%) for the treatment of adults with moderate to severe DED compared to vehicle. The two primary outcome measures are change from baseline in Central Corneal Staining Score (CCSS) at 8 weeks and change from baseline in Eye Dryness Score (EDS) Assessed by Visual Analogue Scale at 8 weeks. The trial enrolled 260 patients who were randomized in to either vehicle or tanfanercept treatment arm.

About VELOS-2

VELOS-2 (NCT03846453) is a US-based multicenter, randomized, double-masked, and vehicle-controlled Phase III study evaluating the efficacy and safety of twice-daily tanfanercept (0.25%) ophthalmic solution compared to vehicle in participants with dry eye. The study randomized 637 patients with dry eye to receive either 0.25% tanfanercept eye drops or vehicle to assess the change from baseline in Inferior Corneal Staining Score (ICSS) and Ocular Discomfort Score (ODS).

About HanAll Biopharma

HanAll Biopharma (KRX: 009420.KS) is a global biopharmaceutical company with a presence in Korea, the USA, Japan, and Indonesia with a mission of making meaningful contributions to patients' lives by introducing innovative, impactful medicines to address severe unmet medical needs. HanAll has been operating a portfolio of pharmaceutical products in the therapeutic areas of endocrine, circulatory, and urologic diseases for over 50 years.

HanAll has also expanded its focus to immunology, oncology, neurology, and ophthalmology to discover and develop innovative medicines for patients with diseases for which there are no effective treatments. Its lead pipeline asset, HL161 (INN: batoclimab), an anti-FcRn antibody, is being developed in Phase II and Phase II trials across the world for the treatment of autoimmune diseases including generalized myasthenia gravis (gMG), thyroid eye disease (TED), chronic inflammatory demyelinating polyneuropathy (CIDP), and Graves' disease (GD). Another main asset, HL036 (INN: tanfanercept), a TNF inhibitor protein, is being evaluated in Phase III clinical studies in the US and is also being evaluated in China for the treatment of dry eye disease. HL161ANS, an anti-FcRn antibody targeting multiple indications, and HL192 (ATH-399A), a Nurr1 activator currently targeting Parkinson's Disease, are also being evaluated in Phase 1 clinical studies (healthy volunteers). For further information, visit our website and connect with us on LinkedIn. For any media inquiries, please contact HanAll PR/IR (pr@hanall.com, ir@hanall.com).

Disclaimer statement 

The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements." These forward-looking statements can be identified by the use of forward-looking terminology, including the terms "believes," "estimates," "anticipates," "expects," "intends," "may," "will," or "should" and include statements HanAll (the company, we) makes concerning its 2024 business and financial 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. These may include various significant factors such as our expectations regarding the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities and regulatory approval requirements. In addition, performance may be affected by 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 of technologies and drugs, our limited operating history, and our ability to obtain additional funding for operations and to complete the development and commercialization of 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.