The FDA granted AnaptysBio’s (NASDAQ:ANAB) imsidolimab orphan drug designation for the treatment of generalized pustular psoriasis (GPP).
GPP is a rare, chronic, life-threatening disease characterized by the development of widespread pustules. With no currently approved therapies, this systemic inflammatory disease can result in death from cardio-pulmonary failure, exhaustion or infection.
Imsidolimab is an anti-interleukin-36 receptor (IL-36R) antibody designed to regulate inflammation in GPP patients. The drug candidate is being evaluated in a Phase 2 clinical trial, with data expected in the second half of 2020.
“Receiving orphan drug designation for the treatment of GPP is an important milestone for our wholly-owned imsidolimab program,” Hamza Suria, AnaptysBio’s president and CEO, said in a statement.
“We look forward to advancing clinical development of imsidolimab in GPP, palmoplantar psoriasis and additional clinical indications that may be driven by dysregulated IL-36R signaling,” he added.
