A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MTPS9579A in Patients With Asthma Requiring Inhaled Corticosteroids and a Second Controller

Summary

This is a Phase IIa, randomized, placebo-controlled, double-blind, multicenter, two-arm study to evaluate the efficacy, safety, and pharmacokinetics of MTPS9579A as an add-on therapy in patients with uncontrolled moderate to severe asthma who are receiving daily ICS therapy and at least one of the following additional controller medications: long-acting beta-agonist (LABA), leukotriene modulator (leukotriene modifier \[LTM\] or leukotriene receptor antagonist \[LTRA\]), long-acting muscarinic antagonist (LAMA), or long-acting theophylline preparation.

Timeline

Start

2019-10-31

Primary completion

2022-05-19

Completion

2022-05-19

Outcome

Missed primary endpoint

paper MTPS9579A did not meet the primary endpoint (hazard ratio = 0.90; 95% CI: 0.55-1.47; p = 0.6835); PMID 39250147 ↗

Publications

• Rhee H, Henderson LM, Bauer RN, Wong K, Staton TL, Choy DF, Banerjee P, Poon V, Yoshida K, Chen C, Long K, Sperinde G, Laing ST, Jones NS, Glickstein SB, Dayal P, Fong A, Dash A, Pulka G, Leaker B, Singh D, Bradding P. Airway tryptase levels inform the lack of clinical efficacy of the tryptase inhibitor MTPS9579A in asthma. Allergy. 2024 Nov;79(11):2993-3004. doi: 10.1111/all.16309. Epub 2024 Sep 9.

Drugs

Indications