ASLAN Pharmaceuticals Announces Financial Results and Corporate Updates for Q4 and Full-year 2023

April 12, 2024 by No Comments

In a preliminary review of blinded data from the ongoing TREK-DX study, 45% (10/22) of patients achieved at least a 90% reduction in their EASI score (EASI-90) after 16 weeks. 56% (5/9) of patients with prior inadequate response to dupilumab achieved EASI-90 and 56% (5/9) of patients achieved a vIGA score of 0 or 1 (clear or almost clear skin) after 16 weeks. Topline, unblinded data from the full dataset expected at the end of 2024.
Phase 2 proof-of-concept trial of farudodstat in alopecia areata (the FAST-AA study) has recruited close to 75% of patients; topline data readout expected in Q3 2024.
Positive opinion received from European Patent Office on new patent application of farudodstat with potential to extend protection until at least 2043.
SAN MATEO, Calif. and SINGAPORE, April 12, 2024 — ASLAN Pharmaceuticals (Nasdaq: ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided an update on recent corporate activities.
“2023 marked a significant year for ASLAN, most notably because of the announcement of positive topline results from the TREK-AD Phase 2b study of eblasakimab in patients with moderate-to-severe atopic dermatitis (AD), and also a number of other advancements across our clinical pipeline. We initiated the FAST-AA clinical study of farudodstat in alopecia areata, and generated compelling translational data on eblasakimab that demonstrated the differentiated effects of targeting IL-13R versus IL-4R in the treatment of AD and supports the potential of eblasakimab as a biologic therapy for COPD,” said Dr Carl Firth, CEO, ASLAN Pharmaceuticals.
“The blinded data we recently disclosed from the ongoing TREK-DX study of eblasakimab in dupilumab-experienced AD patients supports the potential of eblasakimab to treat AD patients that do not achieve an optimal response to dupilumab, a significant and underserved population with limited safe and long-term alternative treatment options. We look forward to the topline readout of the full, unblinded dataset from TREK-DX and the topline interim data from the FAST-AA study later this year.”
Fourth quarter 2023 and recent business highlights
Q4 and recent clinical developments
In October 2023, positive topline data from TREK-AD Phase 2b study of eblasakimab in moderate-to-severe AD presented in late-breaker oral presentation.
New data from the Phase 2b TREK-AD study of eblasakimab for the treatment of moderate-to-severe AD was presented in a late-breaking oral presentation at the 32nd Annual European Congress of Dermatology and Venereology.
In October 2023, hosted a key opinion leader (KOL) event on the changes in the clinical trial and treatment landscape in AD.
ASLAN co-hosted an investor event with a leading Clinical Research Organization and KOLs, Jonathan Silverberg, MD PhD MPH (The George Washington University School of Medicine and Health Sciences), and April W. Armstrong, MD MPH (UCLA).
In new analyses of more severe patients (baseline EASI 18 or higher) from the TREK-AD study presented at the event, 55.6% of patients treated with 600mg eblasakimab once every 4 weeks saw at least a 75% reduction in their EASI score (EASI-75) versus 15.4% of patients on placebo, and 30.6% of patients achieved a validated Investigator Global Assessment (vIGA) score of 0 or 1 (clear or almost clear skin) versus 8.0% on placebo.
A replay is available.
In November 2023, data presented in an indication beyond AD for eblasakimab for the first time.
At the Dermatology Drug Development Summit, ASLAN demonstrated the potential utility of eblasakimab in an indication beyond AD via a human translational model of chronic obstructive pulmonary disease (COPD).
The data showed that eblasakimab was effective in reducing IL-4 and IL-13 driven airway hyperresponsiveness.
In December 2023, blinded safety data from the ongoing Phase 2a FAST-AA study of farudodstat in alopecia areata (AA) was disclosed.
The data showed no liver or other major safety concerns to date in patients enrolled, supporting farudodstat’s improved safety profile compared to the first-generation of approved dihydroorotate dehydrogenase (DHODH) inhibitors.
Farudodstat, a highly selective, oral DHODH inhibitor, has the potential to be a first-in-class treatment for AA.
The FAST-AA study has now recruited close to 75% of patients and topline interim data from the study is expected to be available in Q3 2024.
In February 2024, received a favorable opinion from the European Patent Office (EPO) on composition of matter patent application for farudodstat.
The EPO is acting as the International Examiner on a polymorph patent application for farudodstat, which, if granted in the national stages, will extend effective patent protection for farudodstat until at least 2043.
In March 2024, announced positive translational data from a head-to-head study of eblasakimab versus dupilumab in a human tissue model of COPD.
In the study, eblasakimab performed better than dupilumab in improving airway function and enhancing bronchodilation at the same concentrations, providing further support for the potential of eblasakimab as a biologic therapy for COPD.
The data has been submitted for presentation at an upcoming scientific conference.
In March 2024, announced preliminary blinded data from the TREK-DX study.
In a review of data from 22 patients treated in the TREK-DX study, 45% (10/22) of patients saw at least a 90% reduction in their EASI score (EASI-90) and 50% (11/22) of patients achieved a vIGA score of 0 or 1 after