FDA clears investigational new drug application for ICP-332

Key takeaways:

• ICP-332’s investigational new drug application was accepted by the FDA.
• ICP-332 is a TYK2 inhibitor that has achieved multiple efficacy endpoints for atopic dermatitis.

The FDA has cleared InnoCare Pharma’s investigational new drug application for ICP-332, according to a press release.

ICP-332 is a tyrosine kinase 2 (TYK2) inhibitor that has achieved multiple efficacy endpoints in a China phase 2 study for the treatment of patients with moderate to severe atopic dermatitis. According to the release, the drug demonstrated an excellent efficacy and safety profile, outperforming other classes of medication.

Currently, there are no TYK2 inhibitors that have obtained marketing approval for the treatment of AD in any country. According to Jasmine Cui, PhD, co-founder, chairwoman and CEO of InnoCare, the company is pursuing this goal.

“InnoCare is dedicated to targeting the global frontier in autoimmune therapy by focusing on B-cell and T-cell pathways,” Cui said in the release. “We are committed to accelerating clinical development and look forward to our innovative drugs benefiting patients with autoimmune diseases as early as possible.”