AnaptysBio Announces Orphan Drug Designation of Imsidolimab For Treatment of Generalized Pustular Psoriasis

• Additional Data and Regulatory Strategy Update From Generalized Pustular Psoriasis (GPP) Phase 2 GALLOP Trial Anticipated During H2 2020
• Palmoplantar pustulosis (PPP) Phase 2 POPLAR Trial Top-Line Data Anticipated in H2 2020
• Company Plans To Expand Clinical Development of Imsidolimab To Additional Indications During H2 2020  

SAN DIEGO, July 08, 2020 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for imsidolimab, the company’s proprietary anti-interleukin-36 receptor (IL-36R) antibody, for the treatment of patients with GPP. 

The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the U.S.  Orphan drug designation may provide certain benefits to AnaptysBio, including market exclusivity upon regulatory approval, if received, exemption of FDA application fees and tax credits for qualified clinical trials. 

“Receiving orphan drug designation for the treatment of GPP is an important milestone for our wholly-owned imsidolimab program,” said Hamza Suria, president and chief executive officer of AnaptysBio. “We look forward to advancing clinical development of imsidolimab in GPP, PPP and additional clinical indications that may be driven by dysregulated IL-36R signaling.”

GPP is a chronic, life-threatening, rare disease with no currently approved therapies. This systemic inflammatory disease is characterized by the development of widespread pustules marked by exacerbations. In severe cases, GPP patients can die from cardio-pulmonary failure, exhaustion and/or infection subsequent to occurrences of pustular flares. Patients with GPP suffer without robust therapeutic options because currently approved psoriasis management therapies have not demonstrated clear efficacy in the treatment of this condition. In addition, these therapies, including high-dose cyclosporine, methotrexate and retinoids, are often tapered or discontinued due to toxicity. Studies have shown that GPP is associated with uncontrolled signaling through the IL-36R, which in some patients can be mediated by genetic mutations. We estimate GPP affects approximately 3,000 patients in the United States.