AstraZeneca’s first-in-class biologic, tozorakimab, has posted a double Phase III win in chronic obstructive pulmonary disease (COPD), which analysts say could position the drug to capture a significant patient share as an add-on therapy.
Tozorakimab’s success was observed in the OBERON (NCT05166889) and TITANIA (NCT05158387) trials, which are pitting a 300mg dose plus standard of care (SoC) inhaled maintenance therapy against placebo and SoC. All patients enrolled on these studies have a history of moderate-to-severe exacerbations while receiving SoC treatment.
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In both trials, tozorakimab significantly diminished the rate of moderate-to-severe annualised COPD exacerbations over placebo across all patient groups – including former and current smokers. Tozorakimab’s exacerbation-reducing efficacy also extended to those with all blood eosinophil and lung function levels.
The exacerbation-prone COPD population also generally tolerated tozorakimab well, with the drug demonstrating a “favourable safety profile” in both studies.
While AstraZeneca did not share specific efficacy or safety data from either trial, the UK-Swedish pharma plans to present the full results of both at an upcoming medical meeting.
Tozorakimab acts by inhibiting interleukin 33 (IL-33) – an alarmin cytokine which contributes to the inflammation and harmful excess mucus production seen in COPD. By blocking IL-33’s signalling capacity in both its reduced and oxidised forms, the drug aims to diminish exacerbations and improve symptoms.
To further explore the potential of this subcutaneous therapy, AstraZeneca is conducting two additional Phase III studies on tozorakimab in COPD. This includes the open-label PROSPERO trial (NCT05742802), which is recruiting patients from the OBERON and TITANIA studies, as well as the MIRANDA study (NCT06040086), which is also evaluating tozorakimab in patients prone to COPD exacerbations.
COPD market sees a fundamental shift
In recent years, the COPD market has undergone a notable change, with multiple blockbuster biologics like Sanofi’s Dupixent (dupilumab) and GSK’s Nucala (mepolizumab) breaking into the adjuvant setting alongside SoC inhaled therapies.
According to Vinie Varkey, associate director of research & analysis at GlobalData, tozorakimab’s ability to target both ST2-dependent inflammatory and mucus production pathways potentially explains the drug’s efficacy across heterogeneous COPD populations regardless of eosinophil levels.
“Tozorakimab’s efficacy across eosinophil levels expands the eligible population substantially, differentiating this therapy from Dupixent, which is restricted to the eosinophilic population,” Varkey added.
This differentiation, Varkey says, gives tozorakimab the potential to capture “a significant patient share” as an add-on therapy, addressing patients ineligible for eosinophil-restricted therapies.
Tozorakimab is not the only IL-33 blocker looking to make its COPD market debut, as Sanofi and Regeneron are currently evaluating the potential of their co-developed biologic, itepekimab. However, the drug did run into a roadblock when it demonstrated mixed Phase III results in 2025. The pair are yet to file for itepekimab’s approval in COPD.
GSK is also looking to expand its COPD legacy with IL-33 inhibitor, GSK3862995B, which is currently in a Phase I trial (NCT06154837) in healthy participants.
If tozorakimab were to secure the regulatory go-ahead in COPD, it would join a market that GlobalData, parent company of Clinical Trials Arena, estimates will grow to $30.8bn in value in 2032.
