Date
2023-05-19- Tanfanercept did not demonstrate statistical significance in either of the primary outcome measures of improvement in central corneal staining score (CCSS) or in improvement in Eye Dryness Score (EDS) assessed at week 8 in subjects with dry eye disease (DED), compared to vehicle.
- However, tanfanercept did demonstrate a highly statistically significant improvement on one of the secondary outcome measures, Schirmer testing of tear volume.
- Tanfanercept demonstrated a similar safety profile compared to vehicle, consistent with the findings of the previous VELOS-1 (Phase II) and VELOS-2 (Phase III) trials.
- HanAll will continue to examine the VELOS-3 data as well as aggregate data across all tanfanercept trials to refine the design for the next study.
Rockville, MD, Seoul, KR – May 19, 2023
HanAll
Biopharma Co., Ltd. (KRX: 009420. KS), a global biopharmaceutical company
committed to discovering and developing innovative medicines for patients,
announced results from the Phase III VELOS-3 trial evaluating the safety and
efficacy of tanfanercept, a novel, topical anti-inflammatory treatment being
studied for the treatment of dry eye disease (DED) in subjects diagnosed with
moderate to severe DED.
The Phase
III 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
in improvement from baseline in Eye Dryness Score via Visual Analogue Scale
(VAS) assessed at week 8 in subjects with dry eye disease (DED), relative to
vehicle.
However, VELOS-3
did demonstrate statistically significant improvement (p<0.001) in the
secondary efficacy endpoint of unanesthesized Schirmer testing to quantify
change from baseline in tear volume in tanfanercept treatment arm relative to
vehicle arm assessed at week 8.
Additionally,
further analysis of Schirmer data in VELOS-3 revealed that the proportion of
subjects whose Schirmer test improved from baseline by 10mm or greater as
assessed at week 8 was statistically significant (p<0.001) in the
tanfanercept treated arm (15%) relative to vehicle arm (4%).
Correspondingly,
in a post hoc analysis of VELOS-2 data (a previous phase III study), when the
subset of subjects that met VELOS-3 inclusion criteria are examined, data from
Schirmer testing also meets statistical significance (p<0.05) for
improvement in subjects in the tanfanercept arm relative to subjects in vehicle
control arm as assessed at week 8.
It is
notable that per the FDA’s 2020 Draft Guidance on dry eye drug development, as
an acceptable primary efficacy endpoint option, the FDA lists the measurement
of a statistically significant difference between the percentage of patients
achieving a 10-millimeter increase or more in Schirmer’s tear test scores. This is in contrast to one of the other efficacy
endpoint options listed by the FDA which includes pursuing not only at least
one objective prespecified sign of dry eye but additionally requires at least
one subjective prespecified symptom of dry eye.
Overall,
tanfanercept was well tolerated and the safety findings from VELOS-3 were
consistent with those of the previous studies without any significant new
adverse events observed.
“The
analyses of the Schirmer results for both phase III trials are highly
encouraging for the impact it may have for dry eye disease patients and provides a compelling rationale for further development
of tanfanercept. We
would like to thank all the patients and healthcare professionals for their
support and participation,” stated Sean Jeong, M.D., MBA, CEO of HanAll Biopharma.
“HanAll intends to continue its
evaluation of tanfanercept, and our future clinical program will build on the
important learnings from the past three studies. Also, HanAll is exploring
tanfanercept’s further potential at higher concentrations as well as 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.”
The study
data will be shared at upcoming scientific meetings.
HanAll Biopharma and
Daewoong Pharmaceutical are co-developing tanfanercept therapies and hold
global rights for tanfanercept except for within Mainland China, Hong Kong, and
Taiwan.
Tanfanercept
is a novel, potentially first-in-class topical anti-inflammatory treatment
targeting tumor necrosis factor alpha (TNF-α) 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.
VELOS-3
(NCT05109702) is a US-based multicenter, randomized, double-masked,
vehicle-controlled Phase 3 study designed to evaluate the safety and efficacy
of tanfanercept 0.25% for the treatment of adults with moderate to severe DED.
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.
VELOS-2
(NCT03846453) is a US-based multicenter, randomized, double-masked, vehicle-
controlled Phase 3 study designed to evaluate the safety and efficacy of
tanfanercept 0.25% for the treatment of adults with dry eye. The coprimary endpoints
are change from baseline in
inferior corneal fluorescein staining score to week 8 (Pre- to Post-Ora’s CAE ® Dry
Eye Challenge Model which utilizes a controlled adverse environment) and change from baseline in ocular discomfort score to week 8
(Pre-CAE).
Dry eye
disease is a chronic multifactorial disease characterized by ocular surface
inflammation and damage, which can lead to visual impairment and symptoms
significantly impacting quality of life (1,2). DED is a very common condition with prevalence estimation of
14.5% for the US population (3).
(1) Wolffsohn JS, Arita R, Chalmers R, Djalilian
A, Dogru M, Dumbleton K, Gupta PK, Karpecki P, Lazreg S, Pult H, Sullivan BD,
Tomlinson A, Tong L, Villani E, Yoon KC, Jones L, Craig JP. “TFOS DEWS II
Diagnostic Methodology report.” Ocular Surface. 2017 Jul; 15(3):539-574.
(2) Farrand, Kimberly F et al. “Prevalence of
Diagnosed Dry Eye Disease in the United States Among Adults Aged 18 Years and
Older.” American journal of ophthalmology. 2017; vol. 182: 90-98.
(3) Paulsen AJ, Cruickshanks
KJ, Fischer ME, et al. Dry eye in the Beaver Dam Offspring Study: Prevalence,
Risk Factors, and Health-related Quality of Life. American Journal of
Ophthalmology. 2014 Apr; 157(4):799-806.
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 ranging from endocrine, circulatory, and urologic diseases for more than 50 years.
HanAll has also expanded its focus to ophthalmology, immunology, oncology and neurology 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 3 and Phase 2 trials across the world for the treatment of autoimmune diseases including myasthenia gravis (MG), thyroid eye disease (TED), chronic inflammatory demyelinating polyneuropathy (CIDP), and Graves’ disease (GD). Another main asset, HL036 (INN: tanfanercept), a TNF-alpha inhibitor protein, is being evaluated in Phase 3 clinical studies in the US and China for the treatment of dry eye disease. For further information connect with us on linkedin. For any media inquiries, please contact HanAll PR/IR (pr@hanall.com, ir@hanall.com).
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