A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SPR720 as Compared With Placebo for the Treatment of Participants With Mycobacterium Avium Complex (MAC) Pulmonary Disease

• Status: Not yet recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate

1. The microbiological response and clinical efficacy of SPR720 compared with placebo in participants with nontuberculous mycobacteria pulmonary disease (NTM-PD).

2. The safety and tolerability of SPR720 in a participants population with NTM- PD

3. The pharmacokinetic (PK) of SPR719, active moiety, following orally (po) administered prodrug SPR720 in a participant population with NTM-PD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spero Therapeutics

Criteria

Inclusion Criteria:

1. Has a prior diagnosis of NTM-PD due to MAC

2. Has at least one prior positive culture (sputum or bronchoalveolar lavage) for MAC in the previous 6 months

3. Has an induced sputum culture at screening positive for MAC by at least one of the following methods performed by the microbiological laboratory: quantitative culture on solid agar or growth on liquid media using Mycobacteria Growth Indicator Tubes (MGIT)

4. Is either treatment naïve and has not received any prior treatment for MAC, OR if previously treated for MAC and meets all of the following criteria:

1. Has a history of successful treatment with culture conversion

2. Has recent culture evidence of persistent, recurrent, or relapsed disease and

3. Has been off therapy for at least 3 months

5. Has clinical signs and symptoms within the 6 weeks prior to consent that are consistent with NTM-PD

6. Has a measured forced expiratory volume in 1 second (% predicted forced expiratory volume in 1 second [FEV1]) ≥30% on pulmonary function test within 3 months prior to consent

Exclusion Criteria:

1. In the opinion of the Investigator, is not a candidate for a 4-month delay in initiation of standard multidrug therapy in order to participate in a placebo-controlled clinical trial or observation (e.g., severe symptoms, extensive disease burden).

2. Has disseminated or extrapulmonary NTM.

3. Has end-stage NTM-PD or treatment-refractory NTM-PD.

4. Has isolation on sputum cultures of any species of Mycobacterium other than a species included in MAC within the past 6 months.

5. Has any other condition or prior therapy, which, in the opinion of the Investigator, would make the participant unsuitable for this study, including compliance with all study assessments and adherence to the protocol schedule.

6. Prior exposure to SPR720. Participants who are unable to comply with the requirements of the study or who in the opinion of the Investigator should not participate in the study are not eligible.

• Other inclusion and exclusion criteria as per protocol may apply.