AnaptysBio Reports ANB020 Top-Line Phase 1 Clinical Trial Results

Oct 03, 2016

– Favorable Safety and Pharmacodynamic Parameters Demonstrated in Healthy Volunteers

– US IND and UK CTA Filings Submitted To Enable Multiple Phase 2 Trials

SAN DIEGO, California — AnaptysBio, Inc., a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation and immuno-oncology, today announced top-line results from a single and multiple ascending dose Phase 1 trial of ANB020, a novel anti-interleukin-33 (IL-33) therapeutic antibody.

In the double-blind, placebo-controlled Phase 1 trial, 96 healthy volunteer subjects were dosed with either a single subcutaneous or intravenous dose of ANB020 ranging between 10 mg and 750 mg, or four multiple doses of ANB020 ranging between 40 mg and 300 mg over a period of four consecutive weeks. ANB020 was well-tolerated and no dose-limiting toxicities were observed at any dose level. An ex vivo pharmacodynamic assay illustrated that a single dose of ANB020 at certain dose levels was sufficient to suppress IL-33 function for approximately three months post-dosing. AnaptysBio plans to report detailed results from this Phase 1 trial at a future scientific conference.

"We continue to be excited by ANB020's potential to treat patients suffering from IL-33-mediated inflammatory conditions," said Hamza Suria, President & CEO of AnaptysBio. "As the only known anti-IL-33 cytokine antibody in clinical development, ANB020 intervenes upstream of IL-4, IL-5 and IL-13 cytokine release and therefore has a potential mechanistic advantage for the treatment of atopic dermatitis, food allergies and asthma. We look forward to generating proof-of-concept data for ANB020 in multiple clinical indications over the upcoming 12 months."

AnaptysBio plans to conduct Phase 2 clinical trials of ANB020 in multiple patient populations, including moderate-to-severe adult atopic dermatitis, severe adult peanut allergy and uncontrolled adult eosinophilic asthma. The company recently submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) and a Clinical Trial Application (CTA) to the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) for ANB020 to enable Phase 2 trials. The aforementioned Phase 1 trial was conducted in Australia under an approved Clinical Trial Notification (CTN).

For additional information about ANB020, please click here.