Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc)

Phase 2 Completed 66 enrolled Paratek Pharmaceuticals Inc

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of oral omadacycline as compared to placebo in the treatment of adults with Nontuberculous Mycobacterial (NTM) pulmonary disease caused by Mycobacterium abscessus complex (MABc)

Timeline

Start: 2021-10-15
Primary completion: 2024-06-17
Completion: 2024-07-17

Outcome

Mixed primary results

registry Omadacycline 300 mg vs Placebo; p = 0.2182; Difference in response rates 14.15; Chi-squared; NCT04922554 ↗

registry Omadacycline 300 mg vs Placebo; p = 0.0460; Difference in response rates 22.15; Chi-squared; NCT04922554 ↗

Publications

Jahanbakhsh S, Howland J, Ndayishimiye Uwineza MO, Thwaites MT, Pillar CM, Serio AW, Anastasiou DM, Hufnagel DA. Evaluation of omadacycline against intracellular Mycobacterium abscessus in an infection model in human macrophages. JAC Antimicrob Resist. 2023 Sep 15;5(5):dlad104. doi: 10.1093/jacamr/dlad104. eCollection 2023 Oct.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Omadacycline	Small molecule	300 mg	Oral