HanAll Biopharma Announces Results from Phase 3 Randomized Dual Mask Active Controlled VELOS-3 Trial Evaluating Tanfanercept 0.25% for the Treatment of Dry Eye Disease

  • Tanfanercept compared to vehicle improved either the primary endpoint of improved central corneal staining score (CCSS) or improved eye dryness score (EDS) assessed at 8 weeks in patients with dry eye disease (DED) did not show statistical significance either. .
  • However, tanfanercept showed a highly statistically significant improvement in one of the secondary outcome measures, the Schirmer test of tear volume.
  • Tanfanercept showed a similar safety profile compared to vehicles, consistent with results from previous VELOS-1 (Phase II) and VELOS-2 (Phase III) trials.
  • HanAll will continue to investigate VELOS-3 data as well as aggregate data across all tanfanercept trials to refine the design of upcoming studies.

Rockville, Maryland and Seoul,Korea , May 19, 2023 /PRNewswire/ — HanAll Biopharma Co., Ltd. (KRX: 009420. KS), a global biopharmaceutical company committed to the discovery and development of innovative medicines for patients, has announced that it has Presented results from the Phase 3 VELOS-3 trial evaluating Tanfanercept is a novel topical anti-inflammatory therapeutic being investigated for the treatment of moderate-to-severe dry eye disease (DED) in subjects diagnosed with it.

The Phase 3 VELOS-3 trial did not demonstrate statistical significance for either of the two primary efficacy endpoints. improvement from baseline in central corneal staining score (CCSS) and improvement from baseline in visual analogue scale (VAS) eye dryness score. Subject with dry eye disease (DED) at her 8th week (compared to vehicle).

However, VELOS-3 did not perform well in the secondary efficacy endpoint of the non-anesthetic Schirmer trial, which quantified changes from baseline in tear volume in the tanfanercept-treated group compared with the vehicle group assessed at week 8. demonstrated a statistically significant improvement (p<0.001).

In addition, further analysis of VELOS-3 Schirmer data showed that the proportion of subjects with Schirmer test improvement of 10 mm or more from baseline at the 8-week assessment was statistically significant in the tanfanercept-treated group (15%). was (p<0.001). To vehicle arm (4%).

Similarly, a post-hoc analysis of the VELOS-2 data (previous phase III study) showed statistical significance (p<0.05) for improvement in the Schirmer test data when testing a subset of subjects meeting the VELOS-3 inclusion criteria. fulfilled. in subjects in the tanfanercept group compared to subjects in the vehicle control group, assessed at week 8.

Worth noting is the statistical difference between the proportion of patients achieving an increase of 10 mm or more in Schirmer tears as an acceptable primary efficacy endpoint option according to the FDA’s 2020 Draft Guidance for Dry Eye Therapeutic Drug Development. The FDA lists measures of significant difference in test score. This is in contrast to one of the other efficacy endpoint options listed by the FDA. This option not only seeks at least one objective pre-specified symptom of dry eye, but additionally requires at least one subjectively pre-specified symptom of dry eye.

Overall, tanfanercept was well tolerated and the safety findings for VELOS-3 were consistent with those of previous studies, with no serious new adverse events observed.

“Analysis of the Schirmer trial results from both Phase 3 trials is very encouraging regarding its potential impact on patients with dry eye disease and provides a compelling rationale for further development of tanfanercept. We would like to thank all our patients and healthcare workers for their cooperation,” said Dr. Sean John, MD, MBA, CEO of HanAll Biopharma. “HanAll intends to continue evaluating tanfanercept, and our future clinical program will build on key findings from the past three studies. We are researching potential and additional indications, and we are planning our next study.” intend to do something. “

Research data will be shared at an upcoming academic conference.

HanAll Biopharma and Daewoong Pharmaceutical are co-developing tanfanercept therapy and hold global rights to tanfanercept excluding mainland China. Hong Kongand Taiwan.

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

VELOS-3 (NCT05109702) is a US-based multicenter randomized controlled trial designed to evaluate the safety and efficacy of tanfanercept 0.25% in the treatment of adults with moderate to severe DED This is a double mask vehicle-controlled phase 3 trial. The two primary endpoints were change from baseline in central corneal staining score (CCSS) after 8 weeks and change from baseline in dry eye score (EDS) assessed by Visual Analogue Scale after 8 weeks. .

VELOS-2 (NCT03846453) is a US-based, multicenter, randomized, double-mask vehicle-controlled study designed to evaluate the safety and efficacy of tanfanercept 0.25% in the treatment of adults with dry eye. It is a Phase 3 trial. Co-primary endpoint is change from baseline to week 8 in inferior corneal fluorescein staining score (Ora before and after his CAE) ® dry eye challenge model utilizing a controlled adverse environment) and change from baseline to week 8 (Pre-CAE) in ocular discomfort scores.

Dry eye disease is a chronic, multifactorial disease characterized by inflammation and damage to the ocular surface, which can lead to vision impairment and symptoms that significantly impact quality of life. (1,2). DED is a very common condition, with an estimated prevalence of 14.5% in the US population. (3).

(1) Wolfsohn JS, Alita R, Chalmers R, Jalilian A, Dogru M, Dumbleton K, Gupta PK, Karpecchi P, Razreg S, Palto H, Sullivan BD, Tomlinson A, Tong L, Villani E, Yoon KC. , Jones L, Craig JP. “TFOS DEWS II Diagnostic Methodology Report”. surface of the eye. 2017 Jul;15(3):539-574.

(2) Farrand, Kimberly F, et al. “Prevalence of Diagnosed Dry Eye Disease usa Between adults over the age of 18. American Journal of Ophthalmology, 2017, 182:90-98.

(3) Paulsen AJ, Cruickshanks KJ, Fischer ME, et al. Dry eye in beaver dam progeny studies: prevalence, risk factors, and health-related quality of life. American Journal of Ophthalmology. 2014 Apr;157(4):799-806.


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Source: HanAll Biopharma

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