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

NCT05496374 | Completed Phase 2 FDA Drug

• 1 other identifier: SPR720-202
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 28

Brief Summary

The purpose of the study is to evaluate

1. 1.The microbiological response and clinical efficacy of SPR720 compared with placebo in participants with nontuberculous mycobacteria pulmonary disease (NTM-PD).
2. 2.The safety and tolerability of SPR720 in participants with NTM- PD
3. 3.The pharmacokinetic (PK) of SPR719, active moiety, following orally (po) administered prodrug SPR720 in participants with NTM-PD.

Conditions

Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD)

Keywords

Mycobacterium avium Complex; MAC; Pulmonary disease

Outcome Measures

Primary Outcomes (1)

• Slope of the Weekly Sputum Log10 Colony Forming Units Per Millilitre (CFU/mL) Change From Day 1 Through 56 in micro-Intent to Treat (m-ITT) Population

  Days 1 through 56 (end of the treatment [EOT])

Secondary Outcomes (20)

• Slope of the Weekly Sputum Log10 CFU/mL Change From Days 1 Through 28 in micro-ITT Population

  Days 1 through 28

• Slope of the Time to Positivity (TTP) using Mycobacteria Growth Indicator Tube (MGIT) on Samples of Induced Sputum From Days 1 Through 56 (EOT) in micro-ITT Population

  Days 1 through 56 (EOT)

• Change from Baseline in the Sputum Log10 CFU/mL in the micro-ITT Population

  Days 1 through 56 (EOT)

• Change from Baseline in the Sputum TTP Using MGIT in micro-ITT Population

  Days 1 through 56 (EOT)

• Time to Negative Sputum Culture in micro-ITT Population

  Days 1 through 56 (EOT)

Study Arms (5)

Investigator Blind: Placebo

PLACEBO COMPARATOR

Participants received SPR720 matching-placebo capsules, orally, once daily (QD) for 56 days.

Drug: Placebo

Investigator Blind: SPR720 500 mg

EXPERIMENTAL

Participants received SPR720 500 mg (250 mg × 2) capsules along with 2 SPR720 matching- placebo capsules, orally, QD for 56 days.

Drug: SPR720 500 mg

Investigator Blind: SPR720 1000 mg

EXPERIMENTAL

Participants received SPR720 1000 mg (250 mg × 4) capsules, orally, QD for 56 days.

Drug: SPR720 1000 mg

Open-label: SPR720 1000 mg

EXPERIMENTAL

Participants received SPR720 1000 mg (250 mg × 4) capsules, orally, QD for 56 days.

Drug: SPR720 1000 mg

Open-label: SPR720 500 mg

EXPERIMENTAL

Participants received SPR720 500 mg (250 mg × 2) capsules, orally, twice daily (BID) for 56 days.

Drug: SPR720 500 mg

Interventions

Placebo DRUG

Placebo-matching capsules was administered orally.

Investigator Blind: Placebo

SPR720 500 mg DRUG

SPR720 500 mg (250 mg × 2 capsules) was administered orally.

Investigator Blind: SPR720 500 mg; Open-label: SPR720 500 mg

SPR720 1000 mg DRUG

SPR720 500 mg (250 mg × 4 capsules) was administered orally.

Investigator Blind: SPR720 1000 mg; Open-label: SPR720 1000 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has a prior diagnosis of NTM-PD due to MAC according to American Thoracic Society (ATS) criteria
• Has at least one prior lower respiratory culture (sputum or bronchoalveolar lavage \[BAL\]) positive for MAC in the 12 months prior to consent
• Has an induced sputum culture at Screening positive for MAC by quantitative culture on solid agar
• 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:
• Has a history of successful treatment with sputum culture conversion to negative
• Has recent sputum or BAL culture evidence of recurrent or relapsed disease and
• Has been off therapy for at least 3 months prior to consent
• Has clinical signs and symptoms within the 6 weeks prior to consent that are consistent with NTM-PD with ≥2 of the following:
• chronic cough
• fatigue
• frequent throat clearing
• shortness of breath (dyspnea)
• coughing up of blood (hemoptysis)
• excessive mucus (sputum) production
• fever (temperature \>38ºC or \>100.4ºF)

You may not qualify if:

• In the opinion of the Investigator, is not a candidate for a 5-month delay in initiation of standard multidrug therapy to participate in a placebo-controlled clinical trial (e.g., participant has severe symptoms or, extensive disease burden)
• Has disseminated or extrapulmonary NTM disease
• Has end-stage NTM-PD or treatment-refractory NTM-PD
• Has isolation on lower respiratory (sputum or BAL) cultures of any Mycobacterium species other than those included in MAC within the 6 months prior to consent
• 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 of assessment
• 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

Sponsors & Collaborators

• Spero Therapeutics: lead

Study Sites (28)

Medical Facility

Birmingham, Alabama, 35233, United States

Location

Medical Facility

Fresno, California, 93701, United States

Location

Medical Facility

Los Angeles, California, 90033, United States

Location

Medical Facility

Newport Beach, California, 92663, United States

Location

Medical Facility

Northridge, California, 91324, United States

Location

Medical Facility

Santa Clarita, California, 91355, United States

Location

Medical Facility

Washington D.C., District of Columbia, 20007, United States

Location

Medical Facility

Kissimmee, Florida, 34746-4654, United States

Location

Medical Facility

Loxahatchee Groves, Florida, 33470, United States

Location

Medical Facility

Miami, Florida, 33136, United States

Location

Medical Facility

Sebring, Florida, 33870, United States

Location

Medical Facility

Tampa, Florida, 33606, United States

Location

Medical facility

Atlanta, Georgia, 30342, United States

Location

Medical Facility

Iowa City, Iowa, 52242, United States

Location

Medical Facility

Kansas City, Kansas, 66103, United States

Location

Medical Facility

New Bedford, Massachusetts, 02740, United States

Location

Medical Facility

Rochester, Minnesota, 55905, United States

Location

Medical Facility

Lebanon, New Hampshire, 03756, United States

Location

Medical Facility

New Hyde Park, New York, 11042, United States

Location

Medical Facility

Chapel Hill, North Carolina, 27599, United States

Location

Medical Facility

Winston-Salem, North Carolina, 27103, United States

Location

Medical Facility

Cleveland, Ohio, 44106, United States

Location

Medical Facility

Portland, Oregon, 97239, United States

Location

Medical Facility

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical Facility

Charleston, South Carolina, 29425, United States

Location

Medical Facility

Denison, Texas, 75020, United States

Location

Medical Facility

Sherman, Texas, 75090, United States

Location

Medical Facility

Tyler, Texas, 75708, United States

Location

MeSH Terms

Conditions

Mycobacterium avium-intracellulare Infection; Lung Diseases

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Diseases

Study Officials

• Xilla Ussrey, MD

  Spero Therapeutics Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 11, 2022
• Study Start: December 14, 2022
• Primary Completion: October 8, 2024
• Study Completion: December 2, 2024
• Last Updated: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (28)