AstraZeneca PLC / Pieris Pharmaceuticals, Inc.

Severe Asthma (Type 2 inflammation)

$7.8B Global asthma biologics market 2024

Disease Overview

Severe asthma — predominantly the type 2-high endotype driven by IL-4, IL-5 and IL-13 — affects roughly 5-10% of the 25M Americans with asthma and is responsible for the majority of exacerbations, hospitalizations and asthma-related healthcare costs. The biologics market has been transformed since 2015 by injectable monoclonal antibodies, but a meaningful share of severe patients remain inadequately controlled or intolerant of injection regimens.

Competitive Landscape

When AstraZeneca licensed Pieris's PRS-060 / elarekibep in May 2017, severe asthma biologics were dominated by Xolair (omalizumab, anti-IgE), Nucala (mepolizumab, anti-IL-5), Cinqair (reslizumab) and Fasenra (benralizumab, anti-IL-5R). Sanofi/Regeneron's Dupixent (dupilumab, anti-IL-4Rα) had just been approved in atopic dermatitis and was advancing rapidly in asthma — making PRS-060 a direct mechanistic competitor to Dupixent but with a differentiated inhaled delivery via dry powder inhaler, theoretically allowing local lung targeting without systemic biologic exposure. Dupixent went on to become a >$10B franchise and the standard-of-care anti-IL-4Rα therapy. AstraZeneca/Amgen's own Tezspire (tezepelumab, anti-TSLP) launched in 2022 as the first biologic for all severe asthma regardless of phenotype, and GSK's depemokimab received FDA approval in 2024. In June 2023 AstraZeneca discontinued elarekibep after a 13-week non-clinical toxicology study revealed inflammation-mediated lung tissue damage incompatible with chronic dosing — Pieris stock fell 58% pre-market and the company restructured. The other four undisclosed Anticalin respiratory programs in the original deal have not advanced publicly, leaving the $2.1B milestone structure essentially unrealized.