ASLAN Pharmaceuticals Announces Scientific Collaboration With Dr Emma Guttman-Yassky on Identification of ASLAN004-Specific Biomarkers
ASLAN Pharmaceuticals (Nasdaq: ASLN) announced a collaboration with Dr. Emma Guttman-Yassky to enhance research on ASLAN004 in treating moderate-to-severe atopic dermatitis (AD). Dr. Guttman-Yassky will evaluate biomarkers linked to inflammation in AD, aiming to uncover the treatment mechanisms of ASLAN004. Previous Phase 1b trial results indicated that ASLAN004 successfully met primary and secondary endpoints, showcasing its potential as a novel therapy for AD. The company expects to enroll the first patient in its Phase 2b study within the fourth quarter of 2021.
- ASLAN004 met primary and secondary endpoints in the Phase 1b trial, establishing proof of concept.
- Demonstrated statistically significant improvements in key efficacy endpoints, including EASI and POEM.
- ASLAN004 was well-tolerated across all doses, with no emerging safety concerns.
- None.
MENLO PARK, Calif. and SINGAPORE, Oct. 22, 2021 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals (Nasdaq: ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced a collaboration with renowned inflammatory skin disease expert Dr Emma Guttman-Yassky, MD PhD, to conduct research that will continue throughout ASLAN’s Phase 2b program to identify and characterize the effects of ASLAN004 on disease-associated skin and serum-biomarkers in adults with moderate-to-severe atopic dermatitis (AD).
Dr Guttman-Yassky is Chair of the Department of Dermatology at the Icahn School of Medicine at Mount Sinai and a world leader on inflammatory skin diseases. Her research has led to significant breakthroughs in the understanding of the immunologic basis of AD, providing the scientific community with greater clarity on the pathophysiology of the disease, which is complex and multifactorial.
In the study, Dr Guttman-Yassky and her team will be evaluating a complex cadre of skin and serum biomarkers, including those from the T helper (Th) 2 and Th22 inflammatory pathways, known to play a critical role in the inflammation that is characteristic of AD. The study aims to provide insight into the cellular and molecular mechanisms of ASLAN004 that may correlate with clinical efficacy, by identifying the key biomarkers and pathways altered by ASLAN004 during the treatment period.
Dr Guttman-Yassky, Chair, Department of Dermatology, Icahn School of Medicine at Mount Sinai Hospital, commented: “After the robust, early-stage, proof-of-concept data announced recently by ASLAN, I’m excited to be working with the ASLAN clinical team on employing biomarker strategies that will advance our understanding of ASLAN004 as a pathway-specific molecule in AD. There is a significant unmet need in this disease, and existing standards of care do not work for all patients, many of whom have different therapeutic needs or treatment preferences. I look forward to building upon the recent data set supportive of ASLAN004 as a potentially novel, differentiated treatment option for these patients.”
Dr Guttman-Yassky has developed comprehensive molecular maps of AD, defining skin differentiation and immune-circuits characterizing this disease. She has established the reversibility of the AD phenotypes and defined a series of disease-specific, response-dependent biomarkers that are now accelerating testing of novel immune, pathway-specific drugs in this disease. Her research is the first to identify in humans a distinct population of T-cells that independently produce IL-22, conceptualizing AD as a Th2/Th22-polarized disease.
Dr Karen Veverka, Vice President, Medical, ASLAN Pharmaceuticals, said: “We are fortunate to be collaborating with Dr Guttman-Yassky and her team for our Phase 2b trial of ASLAN004 in moderate-to-severe AD patients and we expect to enroll the first patient in this study later this quarter. Advancing our knowledge about the effects of ASLAN004 in patients, while developing a deeper understanding of its differentiation versus other pathway-specific treatments, is an important next step in our development of ASLAN004 as a potential best-in-class, novel treatment option.”
Media and IR contacts
| Emma Thompson Spurwing Communications Tel: +65 6206 7350 Email: ASLAN@spurwingcomms.com | Ashley R. Robinson LifeSci Advisors, LLC Tel: +1 (617) 430-7577 Email: arr@lifesciadvisors.com |
Summary of recently announced key study results on ASLAN004
Data released last month from a Phase 1b MAD trial demonstrated that the key primary and secondary endpoints were met and conclusively established proof of concept, supporting the potential of ASLAN004 as a differentiated, novel treatment for AD.
In the ITT population, ASLAN004 achieved a statistically significant improvement versus placebo in the primary efficacy endpoint of percent change from baseline in Eczema Area Severity Index (EASI) and showed a greater improvement over placebo in the key efficacy endpoints. ASLAN004 also showed statistically significant improvements in other key efficacy endpoints: EASI-50, EASI-75, peak pruritus and the Patient-Oriented Eczema Measure (POEM). Importantly, ASLAN004 was shown to be well-tolerated across all doses with no emerging safety concerns.
ASLAN is on track to enroll the first patient in its global, 300-patient Phase 2b study of ASLAN004 for the treatment of AD in 4Q 2021.
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.
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