Chiesi Discontinues COPD Drug Tanimilast After Phase III Trial Failure
核心洞察
Chiesi Group (搜索) has discontinued development of tanimilast, an inhaled PDE4 (搜索) inhibitor for COPD (搜索) and asthma (搜索), following failure of the Phase III PILASTER study to meet primary endpoints.
The 52-week trial failed to demonstrate reduction in moderate-to-severe COPD (搜索) exacerbations, with no significant impact on time to first exacerbation or annual severe exacerbation rates.
The setback affects Chiesi's respiratory portfolio, though the company continues global Phase III studies for its existing BDP/FF/GB and BDP/FF combination therapies.
Chiesi Group (搜索) has terminated development of tanimilast, its late-stage chronic obstructive pulmonary disease (COPD (搜索)) and asthma (搜索) candidate, following disappointing results from the Phase III PILASTER study. The Italian pharmaceutical company announced on November 3 that the inhaled phosphodiesterase-4 (搜索) (PDE4 (搜索)) inhibitor failed to meet its primary endpoint of reducing moderate-to-severe COPD exacerbations during a 52-week treatment period.
Trial Results and Clinical Impact
The Phase III PILASTER study (NCT04636801) evaluated tanimilast's efficacy in COPD (搜索) patients over 52 weeks but failed to demonstrate clinical benefit. Beyond missing the primary endpoint, tanimilast also fell short on secondary measures, showing no significant impact on patients' time to first moderate or severe exacerbation and no notable reduction in the annual rate of severe exacerbations.
Chiesi acknowledged in its statement that while the trial outcome was "disappointing," it reflects the complexities of respiratory disease and the associated challenges of developing COPD (搜索) drugs. The failure represents a significant setback for the company's respiratory disease pipeline.
Impact on Chiesi's Portfolio
The discontinuation affects Chiesi's respiratory portfolio, which currently includes two combination treatments for COPD (搜索) and asthma (搜索): BDP/FF/GB (beclomethasone dipropionate/formoterol fumarate/glycopyrronium bromide) and BDP/FF alone. Both formulations are currently approved only for use in the European Union.
Despite the tanimilast setback, Chiesi continues to advance its existing assets through two global Phase III studies evaluating the efficacy and safety of both BDP/FF/GB and BDP/FF combinations. These trials could potentially secure approval for the treatments in the United States and other key global markets.
Competitive COPD Landscape
The COPD (搜索) market has seen significant activity with new targeted therapies becoming available to patients. Sanofi's Dupixent (dupilumab) made history in 2024 as the first biologic to receive FDA approval for COPD treatment. GlobalData analysts forecast Dupixent's COPD sales will reach $6.57 billion for Sanofi and Regeneron by 2033, representing a 600% increase from the projected $928 million in 2025.
Key opinion leaders interviewed by GlobalData analysts expressed optimism about Dupixent's potential to dominate the COPD (搜索) market. However, competition is emerging from GSK's Nucala (mepolizumab), which received FDA approval for COPD in May 2025 after establishing itself in severe asthma (搜索) since 2015.
Healthcare analyst Asiyah Nawab from GlobalData noted that key opinion leaders "indicated confidence" in Nucala's potential, reflecting "a level of trust" with the therapy that will likely translate to other indications. GlobalData's patient-based forecast predicts Nucala will generate $3.45 billion in COPD (搜索) revenue by 2033.
The evolving COPD (搜索) treatment landscape underscores both the significant unmet medical need in this indication and the challenges pharmaceutical companies face in developing effective therapies for this complex respiratory condition.