▎WuXiEdited by the Kant Content Team

Amgen and AstraZeneca announced their "first-in-class" monoclonal antibody Tezspire (tezepelumab)InUseFor the treatment of moderate to very severe chronic obstructive pulmonary disease(COPD) patientsThe 2Phase a Clinical TrialThe Result。The trial enrolled patients regardless of the presence of emphysema, chronic bronchitis, or smoking history, and their baseline blood eosinophil count (BEC) ranged widely. Subgroup analysis showed that,Tezepelumab can reduce the incidence of moderate or severe COPD exacerbations.Currently, the two companies are planning a Phase 3 trial to evaluate the efficacy of tezepelumab in patients with COPD.

Preliminary results showed that, at Week 52, treatment with tezepelumab numerically reduced the annual rate of moderate or severe COPD exacerbations by 17% compared to placebo, but this was not statistically significant (90% CI: -6, 36; one-sided p-value = 0.1042). However,Importantly, this proof-of-concept study showed that, in patients with BEC ≥150 cells/µL, tezepelumab numerically reduced the rate of moderate or severe COPD exacerbations by 37% compared to placebo.Studies show that approximately 65% of COPD patients have a BEC ≥150 cells/μL.In patients with BEC ≥300 cells/μL, tezepelumab numerically reduced the rate of moderate or severe COPD exacerbations by 46%.

▲TEzepelumab Improves COPD Exacerbation (Image Source: Reference [1])

In addition,Tezepelumab treatment also enabled patients toBefore Using BronchodilatorsAn improvement trend was observed in forced expiratory volume in one second (FEV1) and the total score of St. George's Respiratory Questionnaire (SGRQ).Compared with placebo, the FEV1 of patients in the BEC ≥150 and ≥300 cells/μL groups improved by 63 mL and 146 mL, respectively, and the SGRQ scores improved by 4.2 points and 9.5 points, respectively. The SGRQ questionnaire is an indicator that measures patient-reported health-related quality of life improvement.

▲TEzepelumab Improves Patients' Lung Capacity and Quality of Life (Image Source: Reference [1])

In terms of safety, the safety and tolerability profile of tezepelumab is consistent with its previously approved indications; the most commonly reported (>10%) adverse events for tezepelumab are COPD exacerbations (12.1%) and COVID-19 infection events (14.5%).

Tezepelumab is a “first-in-class” human-derived, targeted anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody.TSLP is an epithelial cell factor located at the top of many inflammatory cascades, capable of triggering excessive immune responses to allergic, eosinophilic, and other types of airway inflammation. This therapy received approval from the U.S. FDA in December 2021.ApprovalUsed as an additional maintenance therapy to treat severe asthma in children aged 12 years and older and adults. In addition to severe asthma, tezepelumab is also being developed for the treatment of other potential indications, including chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, and eosinophilic esophagitis.

▲TSLP affects immune responses in various immune cells (Image source: Reference [2])