Eblasakimab is a monoclonal antibody candidate targeting the IL-13 receptor that has the potential to deliver a differentiated efficacy and safety profile for the treatment of moderate-to-severe atopic dermatitis (AD). The treatment is currently in Phase 2 trials.
ASLAN, which has locations in California and Singapore, has developed a high concentration formulation of eblasakimab, allowing up to 400mg eblasakimab to be administered in a single subcutaneous injection and suitable for use with different devices. Thermo Fisher is set to commence manufacturing the new formulation in its commercial-scale Good Manufacturing Practices (GMP) certified manufacturing facilities this month.
“This partnership with ASLAN is an example of how our world-class development and manufacturing expertise can be used to deliver innovative formulations at scale,” said Leon Wyszkowski, Thermo Fisher’s president of pharma services commercial operations. “Our technology, including the 5,000-L Single-Use Bioreactor (SUB), will be used to manufacture the new high concentration formulation of eblasakimab and will enable larger-scale, single-use capabilities for late-stage trials and commercialization of this potential treatment for AD patients.”
The TREK-AD trial, a global randomized, double-blind, placebo-controlled, dose-ranging, Phase 2b clinical trial, is evaluating the efficacy and safety of eblasakimab in adult patients with moderate-to-severe AD. Topline data from this trial is expected in the second quarter of 2023.
ASLAN is also conducting the TREK-DX study to evaluate eblasakimab in adult patients with moderate-to-severe AD who have previously been treated with dupilumab. Topline data from the TREK-DX study is expected in the first quarter of 2024.