AstraZeneca's Triple-Combination Therapy Breztri Hits Primary Goals In Two Pivotal Studies For Asthma
On Friday, AstraZeneca Plc (NASDAQ:AZN) reported topline data from Phase 3 KALOS and LOGOS trials in patients with uncontrolled asthma.
KALOS and LOGOS trials assessed the efficacy and safety of Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF) compared with two fixed-dose, dual-combination therapies of budesonid (an ICS) and formoterol fumarate (LABA) and Symbicort pressurized metered-dose inhaler (pMDI).
KALOS and LOGOS included approximately 4,400 randomized patients.
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The trials met all primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in lung function compared with dual-combination inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) medicines.
No new safety or tolerability signals were identified for Breztri in KALOS or LOGOS.
Full results from the two Phase 3 trials will be shared with regulatory authorities and presented at an upcoming medical meeting.
Breztri is an inhaled triple-combination therapy approved for chronic obstructive pulmonary disease (COPD) in adults in more than 80 countries worldwide, including the US, EU, China, and Japan.
In addition to the two registrational trials (KALOS and LOGOS), two qualifying trials, LITHOS and VATHOS, also met their primary endpoints. LITHOS and VATHOS included approximately 1,000 randomized patients.
In April, Sanofi SA (NASDAQ:SNY) reported preliminary results from the TIDE-Asthma phase 2 study of amlitelimab and its efficacy in heterogeneous inflammatory asthma.
- The primary endpoint of the annualized exacerbation rate at week 48 was not met at the highest dose level, leading to nominal significance at the medium and low doses.
- Treatment with amlitelimab led to nominally significant and clinically meaningful reductions in asthma exacerbations at the medium dose tested and a numerically greater reduction in exacerbations at the high dose at week 60.
- A nominally significant and clinically meaningful improvement in secondary endpoints of lung function and asthma control was evident.
- In a patient subgroup, amlitelimab showed nominally significant and clinically meaningful improvements in exacerbations (with a reduction of more than 70%), lung function, and asthma control at week 60.
AstraZeneca announced in its first-quarter presentation (PDF) on Tuesday that it had stopped working on a phase 1 Alzheimer's disease drug and two phase 2 programs for migraine and osteoarthritis pain and painful diabetic neuropathy.
On Tuesday, the European pharma giant reported first-quarter 2025 sales of $13.59 billion, up 7% year over year (+10% at constant currency), slightly missing the consensus of $13.71 billion, driven by double-digit growth in oncology and biopharmaceuticals.
Price Action: AZN stock is up 1.52% at $71.58 at the last check Friday.
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