GB001 in Adult Subjects With Moderate to Severe Asthma

Summary

A randomized, double-blind, placebo-controlled, dose-ranging, multi-center study to evaluate the efficacy and safety of GB001 when added to standard-of care (SOC) asthma maintenance therapy in adults with moderate to severe asthma and an eosinophilic phenotype with respect to asthma worsening at the end of 24 weeks of treatment.

Timeline

Start

2018-10-22

Primary completion

2020-07-23

Completion

2020-08-18

Outcome

Missed primary endpoint

paper Although GB001 did not significantly reduce the odds of asthma worsening, reductions favoring GB001 were observed. PMID 35248549 ↗

registry analysis (superiority test); Placebo vs GB001 20 mg; p = 0.1425; Odds Ratio (OR) 0.674 (95% CI 0.398 to 1.142); Regression, Logistic NCT03683576 ↗

Publications

• Moss MH, Lugogo NL, Castro M, Hanania NA, Ludwig-Sengpiel A, Saralaya D, Dobek R, Ojanguren I, Vyshnyvetskyy I, Bruey JM, Osterhout R, Tompkins CA, Dittrich K, Raghupathi K, Ortega H; LEDA Investigators. Results of a Phase 2b Trial With GB001, a Prostaglandin D2 Receptor 2 Antagonist, in Moderate to Severe Eosinophilic Asthma. Chest. 2022 Aug;162(2):297-308. doi: 10.1016/j.chest.2022.02.038. Epub 2022 Mar 3.
• Ortega H, Fitzgerald M, Raghupathi K, Tompkins CA, Shen J, Dittrich K, Pattwell C, Singh D. A phase 2 study to evaluate the safety, efficacy and pharmacokinetics of DP2 antagonist GB001 and to explore biomarkers of airway inflammation in mild-to-moderate asthma. Clin Exp Allergy. 2020 Feb;50(2):189-197. doi: 10.1111/cea.13524. Epub 2019 Nov 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GB001	Peptide	20 mg	Oral
Subject	GB001	Peptide	40 mg	Oral
Subject	GB001	Peptide	60 mg	Oral

Indications