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ASLAN Pharmaceuticals Announces Positive Data Conclusively Establishing Proof of Concept for ASLAN004 in Atopic Dermatitis
- Topline data from multiple-ascending-dose study supports a potentially differentiated safety and efficacy profile
- ASLAN004 achieved a statistically significant improvement (p<0.0251) versus placebo in the primary efficacy endpoint of percent change from baseline in EASI with significant improvements in other efficacy endpoints
In March 2021, ASLAN announced interim data from three dose escalation cohorts, then continued to enroll and treat an additional 27 patients in an expansion cohort at the highest dose (600mg). The results announced today compare results from all patients receiving 600mg to all receiving placebo (n=39). The Intent to Treat (ITT) population (n=38) comprised patients from 10 sites and represented all patients dosed excluding one patient that discontinued from the study prematurely due to COVID-19 restrictions.
ASLAN004 achieved a statistically significant improvement (p<0.0251) versus placebo in the primary efficacy endpoint of percent change from baseline in the Eczema Area Severity Index (EASI), and also showed significant improvements (p<0.051) in other key efficacy endpoints: EASI-50, EASI-75, peak pruritus and the Patient-Oriented Eczema Measure (POEM).
Following discussions with the Data Monitoring Committee prior to unblinding, a Revised ITT population (RITT, n=29) was defined to exclude one study site at which all patients enrolled in the study appeared atypical of moderate-to-severe AD patients based on biomarkers, such as TARC, and patient medical history2. In the RITT population, which is more comparable to other published studies3 in moderate-to-severe AD, ASLAN004 also achieved a statistically significant improvement (p<0.0251) versus placebo in percent change from baseline in EASI and showed a greater improvement over placebo in the key efficacy endpoints versus the ITT population.
Key study results
Dr Ken Kobayashi, Chief Medical Officer, ASLAN Pharmaceuticals, commented: “We’re delighted to report such positive data on ASLAN004. The data from the study wholly support our view that ASLAN004’s novel mechanism could represent a new treatment option for patients suffering with moderate-to-severe AD, with the potential to deliver best-in-class efficacy and best-in-class safety. We look forward to building upon this strong data set as we initiate the Phase 2b study in the coming weeks and explore monthly dosing regimens that could provide additional convenience to patients.”
Dr Steven Thng, Principal Investigator, said: “Atopic dermatitis is one of the most common dermatological diseases worldwide and presents with a range of symptoms that have a tremendous negative impact on a patient’s quality of life. Patients, especially those with moderate-to-severe disease, are still in great need of novel treatment options that are safe, efficacious and convenient to use to overcome the limitations of options currently available to them. The findings from the study show the potential benefit that ASLAN004 could offer patients in achieving almost completely clear skin and relief from the burden of atopic dermatitis on daily life.”
ASLAN is initiating a global Phase 2b study of ASLAN004 for the treatment of AD and is on track to enroll the first patient in 4Q 2021. ASLAN will host a KOL event on ASLAN004 in AD for investors in 4Q 2021. The full data from the MAD study will be submitted for presentation at a future scientific congress.
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About ASLAN Pharmaceuticals
ASLAN Pharmaceuticals (Nasdaq:ASLN) is a clinical-stage immunology focused biopharmaceutical company developing innovative treatments to transform the lives of patients. ASLAN is currently evaluating ASLAN004, a potential first-in-class antibody targeting the IL-13 receptor, in atopic dermatitis, and ASLAN003, a potent oral inhibitor of DHODH, which is being developed for autoimmune disease. ASLAN has a team in Menlo Park, California, and in Singapore. For additional information, please visit www.aslanpharma.com or follow ASLAN on LinkedIn.
ASLAN004 is a novel, potential first-in-class monoclonal antibody that targets the IL-13 receptor α1 subunit
About the study
The Phase 1 study was a multiple ascending dose study designed to deliver proof of concept and evaluated three doses of ASLAN004 (200mg, 400mg and 600mg) delivered subcutaneously compared to a placebo arm. Patients were dosed weekly for eight weeks to determine the safety and tolerability of ASLAN004, and to assess a number of secondary efficacy outcome measures. In total, 53 patients were randomized in the MAD study from 10 sites in the United States, Australia and Singapore.
This release contains forward-looking statements. These statements are based on the current beliefs and expectations of the management of ASLAN Pharmaceuticals Limited and/or its affiliates (the "Company"). These forward-looking statements may include, but are not limited to, statements regarding the Company’s business strategy and clinical development plans; the Company’s plans to develop and commercialize ASLAN004; the safety and efficacy of ASLAN004, including its potential to be best-in-class; the Company’s plans and expected timing with respect to clinical trials, clinical trial enrolment and clinical trial results for ASLAN004; and the potential for ASLAN004 as a first-in-class treatment for atopic dermatitis. The Company’s estimates, projections and other forward-looking statements are based on management's current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and inherently involve significant known and unknown risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of many risks and uncertainties, which include, unexpected safety or efficacy data observed during preclinical or clinical studies; clinical site activation rates or clinical trial enrolment rates that are lower than expected; the impact of the COVID-19 pandemic on the Company’s business and the global economy; general market conditions; changes in the competitive landscape; and the Company’s ability to obtain sufficient financing to fund its strategic and clinical development plans. Other factors that may cause actual results to differ from those expressed or implied in such forward-looking statements are described in the Company’s US Securities and Exchange Commission filings and reports (Commission File No. 001-38475), including the Company’s Annual Report on Form 20-F filed with the US Securities and Exchange Commission on April 23, 2021. All statements other than statements of historical fact are forward-looking statements. The words “believe,” “view,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan,” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes are intended to identify estimates, projections, and other forward-looking statements. Estimates, projections, and other forward-looking statements speak only as of the date they were made, and, except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement.
1 One-sided p-value. Study was powered to assess statistical significance in the primary efficacy endpoint at the one-sided 5% level.