ASLAN Pharmaceuticals (ASLN) Announces Positive Interim Data From the Multiple Ascending Dose Study of ASLAN004 in Atopic Dermatitis
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ASLAN Pharmaceuticals (Nasdaq: ASLN), a clinical-stage immunology focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced positive interim unblinded data from the three dose cohorts of its ongoing randomised, double-blind placebo controlled multiple ascending dose study of ASLAN004 for the treatment of moderate to severe atopic dermatitis (AD). ASLAN004 was shown to be well tolerated across all doses and showed improvements compared to placebo in all efficacy endpoints, supporting its potential as a differentiated, novel treatment for AD.
The Phase 1 study evaluated three doses of ASLAN004 (200mg, 400mg and 600mg) delivered subcutaneously and is now recruiting a fourth (expansion) cohort (600mg). Patients were dosed weekly for eight weeks to determine the safety and tolerability of ASLAN004 as well as a number of secondary efficacy outcome measures. The first three cohorts randomised 25 patients from the United States, Australia and Singapore. Three patients discontinued study due to restrictions imposed in response to COVID-19. Of the remaining 22 patients, 18 completed at least 29 days of dosing and assessment and were evaluable for efficacy.
- The average baseline Eczema Area Severity Index (EASI) score of patients was 32.5 and the average Investigators Global Assessment (IGA) score was 3.4 (n=18).
- At week 8, the average reduction in EASI from baseline at therapeutic doses (400mg and 600mg cohorts) was 74% (n=9) compared to 42% (n=5) for patients on placebo.
- 89% achieved EASI-50 versus 40% on placebo;
- 67% achieved EASI-75 versus 0% on placebo;
- 56% achieved EASI-90 versus 0% on placebo.
- 22% of patients achieved IGA of 0 or 1 at therapeutic doses versus 0% on placebo.
- Peak pruritus improved after just one dose and continued to improve by an average of 46% relative to baseline at 8 weeks compared to 16% for patients on placebo.
- The proportion of patients with adverse events and treatment-related adverse events were similar across treatment and placebo arms. There were no treatment-related adverse events in the active arm that led to discontinuation.
Dr Ken Kobayashi, Chief Medical Officer, ASLAN Pharmaceuticals, commented: “These data are very encouraging and provide a strong foundation to confidently advance our plans for the global Phase 2b study we intend to initiate later this year. A robust and differentiated safety and efficacy profile is emerging for ASLAN004 and we look forward to reporting the full, unblinded data from approximately 50 patients in mid-2021. We believe the interim data demonstrate ASLAN004’s potential as a first-in-class therapeutic targeting the IL-13 receptor with a differentiated approach to treating atopic dermatitis.”
Conference call and webcast
ASLAN’s management will host a webcast and conference call at 8am ET / 9pm SGT today, 1 March 2021, to discuss these interim data. The live call may be accessed by dialing +1 855 548 1217 for domestic callers and +1 409 217 8810 for international callers and entering the conference code: 9199389. A live webcast of the call will be available using this link: https://edge.media-server.com/mmc/p/o2mdjnyx. It will also be available from the News and Events page of the Company’s website at https://ir.aslanpharma.com/webcasts-presentations and will be archived there after the live event.
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