Aslan Pharmaceuticals is ready to hit go on decentralized clinical trials after the uncertainty of the COVID-19 pandemic forced it into pausing one of its trials for about four months. Now, three months after reporting data from the restarted phase 1 trial for its Dupixent rival hopeful, the biotech is partnering with IQVIA Biotech to handle logistics related to decentralized trials.
In those early days of the pandemic, Aslan pressed pause on a study of its CSL-licensed antibody, ASLAN004, in moderate to severe atopic dermatitis. Aslan first secured a stake in the drug in 2014 and then took on the global rights from CSL in May 2019 in a deal that included a $30 million payment once the treatment enters phase 3.
In August 2020, Aslan resumed the phase 1 multiple ascending-dose study it halted.
The results came in for the phase 1 study in September, and Aslan liked what it saw: The eight-week trial showed (PDF) the treatment had a statistically significant improvement change from baseline on an eczema severity score compared to placebo. The drug is being queued up as a potential contender to Regeneron and Sanofi's blockbuster Dupixent.
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Now, Aslan is teaming up with clinical research organization IQVIA to conduct a decentralized trial for the treatment, the company said Monday (PDF). The pair will also work together on clinical development of ASLAN003, which is being tested in inflammatory bowel disease.
For the 300-patient phase 2b ASLAN004 trial in adults with moderate to severe atopic dermatitis, the CRO will help with patient recruitment, clinical monitoring, medical writing and biostatistics. That study is slated to begin this quarter and will be conducted at sites across the U.S., Canada, Europe and Asia.
A phase 2 of ASLAN003 will begin in the first half of next year, the biotech said on its website.