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ASLAN Pharmaceuticals submits clinical trial authorisation application for first in man studies for ASLAN004

Published 05 July 2018

ASLAN Pharmaceuticals has submitted a clinical trial authorisation application with the Singapore Health Sciences Authority (HSA) to initiate a phase 1 trial of ASLAN004.

The single ascending dose study will recruit healthy volunteers and the multiple ascending dose study will recruit patients with atopic dermatitis.

ASLAN004 is a fully human monoclonal antibody that targets the IL-13 receptor α1 subunit (IL-13Rα1) and potently inhibits interleukin 4 (IL-4) and interleukin 13 (IL-13). IL-4 and IL-13 are central to triggering symptoms of allergy in atopic dermatitis, such as redness and itching of the skin.

By targeting IL-13Rα1, ASLAN004 has the potential to offer both a lower dose and dosing frequency than currently available treatments for atopic dermatitis which target the same pathways. ASLAN004’s selective binding may also offer a more favourable side effect profile.

ASLAN Pharmaceuticals CEO Dr Carl Firth said: “We believe that ASLAN004 has the potential to be a best-in-class therapy, offering the potential for reduced injection frequency and greater convenience for patients than current treatment options for atopic dermatitis.”

Atopic dermatitis is the most common dermatological disease, affecting over 200 million patients worldwide1, characterised by red inflamed skin and severe daytime and night time itching, which can severely impact patients’ quality of life. Up to one-third of adult atopic dermatitis patients are considered moderate-to-severe2, for which currently available therapeutics are limited and management is challenging in the majority of cases.

ASLAN004 is a fully human monoclonal antibody that targets the IL-13 receptor α1 subunit, or IL-13Rα1, with potential to be a best-in-class therapy. ASLAN004 is currently in preclinical development. By targeting IL-13Rα1, ASLAN004 potently inhibits signalling of both interleukin 4, or IL-4, and interleukin 13, or IL-13.

IL-4 and IL-13 are central to triggering symptoms of allergy in atopic dermatitis, such as redness and itching of the skin, as well as asthma symptoms such as shortness of breath, wheezing and coughing.

ASLAN Pharmaceuticals is a clinical-stage oncology-focused biopharmaceutical company developing novel therapeutics for global markets. ASLAN targets diseases that are both highly prevalent in Asia and orphan indications in the United States and Europe.

 Led by a senior management team with extensive experience in global and regional development and commercialisation, ASLAN is headquartered in Singapore and has offices in Taiwan and China.

Source: Company Press Release