ASLN - ASLAN Pharmaceuticals Provides Year-End Update on Its Eblasakimab and Farudodstat Programs | Benzinga
- Following the successful TREK-AD Phase 2b study of eblasakimab in moderate-to-severe atopic dermatitis, process is underway to identify potential partners.
- Recruitment in TREK-DX, studying eblasakimab in dupilumab-experienced patients, using updated criteria based on findings from TREK-AD, has commenced at US sites, with additional sites in Europe expected to open in the first half of 2024.
- Review of blinded safety data emerging from FAST-AA study of farudodstat in alopecia areata shows no emerging liver or other safety concerns, supporting the broadening of enrollment criteria to include less severe patients. Topline interim data readout is now expected mid-2024.
- Translational work demonstrating eblasakimab's potential in COPD, with head-to-head data suggesting possible benefits over dupilumab, support potential of eblasakimab to address a wide range of AD comorbidities.
SAN MATEO, Calif. and SINGAPORE, Dec. 12, 2023 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals Ltd. (NASDAQ:ASLN), a clinical-stage, immunology focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today provided a business update and updates related to its programs, eblasakimab and farudodstat.
"Throughout 2023, ASLAN made major progress on multiple fronts – advancing both of our lead programs, eblasakimab and farudodstat in Phase 2 testing, and establishing business development collaborations to further the development and utilization of eblasakimab," said Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals. "The results from the TREK-AD study demonstrated eblasakimab's potential to deliver a monthly dosing regimen in atopic dermatitis, AD, without compromising on efficacy, and become a leading therapy in AD. In addition, we are very encouraged by data from head-to-head translational studies that demonstrate eblasakimab's unique mechanism of action targeting the IL-13 receptor elicits a different response and cytokine profile compared to dupilumab. This provides a basis for eblasakimab's differentiated clinical profile and suggests that it could be efficacious in patients that do not experience an adequate response to dupilumab – something we are testing in our TREK-DX trial. Excitingly, in head-to-head experiments using a human COPD lung model, we have observed eblasakimab deliver stronger effects compared to dupilumab, and we look forward to publishing further data from these studies next year.
"In 2024, we will continue advancing farudodstat as a novel treatment for alopecia areata, or AA," Dr Firth continued. "Unlike other DHODH inhibitors, we have not seen emerging liver or other safety concerns in our review of the blinded safety data from the FAST-AA study. We believe that having an effective drug without the safety liabilities of the JAK inhibitors could provide a valuable treatment option for patients. On this basis, we have broadened the enrollment criteria to include less severe AA patients, who we believe could also benefit but may not be eligible for current approved systemic treatments or other ongoing trials. Finally, as part of our efforts to reduce our cash burn in 2024, we recently amended the terms of our loan agreement with K2 HealthVentures to substantially reduce the total payments due over the next 12 months."
Eblasakimab update
ASLAN is conducting clinical trials of its lead program, eblasakimab, in adult, moderate-to-severe AD patients. In July, ASLAN announced positive topline results from a Phase 2 TREK-AD study that demonstrated eblasakimab's potential as the first biologic in moderate-to-severe AD to demonstrate a competitive efficacy profile with once-monthly dosing from initiation. In October, new data was presented from an analysis of patients with severe disease (baseline Eczema Area and Severity Index [EASI] score at least 21), showing a marked widening in placebo-adjusted efficacy. ASLAN has engaged Seth J. Orlow, MD PhD, of the specialist firm, Pharus, with deep and extensive industry relationships in dermatology, to advise on global partnership discussions for eblasakimab.
ASLAN is also evaluating eblasakimab in the Phase 2 TREK-DX study in dupilumab-experienced, moderate-to-severe AD patients. 63% of dupilumab-treated patients fail to achieve clear or nearly clear skin (Investigator's Global ...