ASLAN Pharma Takes on Full License of Atopic Dermatitis Drug in $775 Million-Plus Deal
Published: May 31, 2019
By Mark Terry
Singapore-based ASLAN Pharmaceuticals amended its global license agreement with CSL Limited to gain full rights to ASLAN004 for all indications. The compound is a fully human monoclonal antibody targeting the IL-13 receptor alpha1 subunit (IL-13Ra1) and is being developed for atopic dermatitis and other inflammatory diseases.
Under the terms of the new deal, ASLAN will pay CSL $30 million once it starts a Phase III trial of the drug. CSL will be eligible for up to $95 million in regulatory milestones, $655 million in sales milestones, and tiered royalties on any net sales between mid-single digits and 10%.
In the original deal, ASLAN handled development of ASLAN004 through proof-of-concept and the identification of a partner to take the project through Phase III and into commercialization. CSL was to receive between 40% and 50% of all revenues of ASLAN004, including any monies from out-licensing agreements.
“We are very excited by the recent data we have generated on ASLAN004 and we believe that it has the potential to be a best-in-class treatment for atopic dermatitis and other inflammatory indications with a differentiated profile,” stated Carl Firth, ASLAN’s chief executive officer. “The amendment of our agreement with CSL is an important achievement in our strategy to gain greater commercial control and retain more value from our pipeline programs. We look forward to reporting further data on ASLAN004 in atopic dermatitis and investigating its potential in other inflammatory indications.”
ASLAN004 is currently in a Phase I clinical trial in healthy patients as a treatment for atopic dermatitis. On March 29, the company announced it had finished the first part of the single ascending dose (SAD) study. It was conducted at one location in Singapore and demonstrated the drug was safe and well tolerated at all intravenous doses in healthy volunteers. In addition, analysis of downstream mediators, such as phosphorylation of STAT6 (pSTAT6), associated with allergic inflammation, showed complete inhibition within one hour of dosing. It stayed effective for more than 29 days, which suggests that a once-a-month dose might be possible.
A subcutaneous formulation is being tested in the second part of the SAD study. In the second half of this year, the company plans to launch a multiple ascending dose trial in moderate to severe atopic dermatitis patients.
At the time, Mark McHale, Head of Research & Development for ASLAN, stated, “ASLAN is the only company with a therapeutic antibody targeting IL-13Ra1, and ASLAN004 is only the second drug after dupilumab [Sanofi/Regeneron’s Dupixent] to target the receptor complex, blocking signaling of both IL-4 and IL-13. Targeting this receptor complex has been shown to be highly effective in atopic dermatitis and, in contrast to ligand blockade, has also been successful in other allergic disease indications, such as asthma. Although there are several drugs in development for atopic dermatitis, no one has yet demonstrated once-monthly dosing with efficacy comparable or superior to dupilumab.”
Atopic dermatitis affects about 200 million people worldwide, noted by red inflamed skin and severe itching. It is the most common dermatological disease.
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