AnaptysBio Announces Clearance of U.S. IND and U.K. CTA for ANB020

Dec 13, 2016

Regulatory Clearances Support Initiation of Phase 2a Trials for the Treatment of Adult Peanut Allergy and Atopic Dermatitis

SAN DIEGO, California — AnaptysBio, Inc., a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation, today announced that the United States Food and Drug Administration has cleared the company's investigational new drug application (IND) for ANB020, a proprietary anti-interleukin-33 antibody, for the treatment of adults with severe peanut allergy, a condition that can result in systemic life-threatening anaphylaxis. In addition, AnaptysBio announced that the United Kingdom Medicines and Healthcare Products Regulatory Agency has cleared the company's clinical trial authorisation (CTA) for ANB020 for the treatment of adults with moderate-to-severe atopic dermatitis, a challenging type of skin inflammation.

"These regulatory milestones represent important steps forward in the development of ANB020, which we believe has the potential to treat a number of atopic diseases, including severe adult peanut allergy and moderate-to-severe adult atopic dermatitis," said Hamza Suria, president and chief executive officer of AnaptysBio. "The recently announced topline data from the Phase 1 trial of ANB020 in healthy volunteers demonstrate favorable safety and ex vivo pharmacodynamics of ANB020. We look forward to initiating Phase 2a clinical trials designed to assess the therapeutic potential of ANB020 for the many patients living with atopic conditions."

AnaptysBio plans to initiate a U.S. Phase 2a trial of ANB020 in adult patients with severe peanut allergy and a U.K. Phase 2a trial in adult patients with moderate-to-severe atopic dermatitis in the first quarter of 2017, and expects to complete both trials during the second half of 2017. In addition, during the first half of 2017, the company plans to seek regulatory clearance to initiate a Phase 2a clinical trial in adult patients with severe eosinophilic asthma, a chronic respiratory disease.