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

Last updated: October 7, 2025
Sponsor: Spero Therapeutics
Overall Status: Completed

Phase

2

Condition

Mac Infection (Mycobacterium Avium Complex)

Treatment

SPR720 500 mg

SPR720 1000 mg

Placebo

Clinical Study ID

NCT05496374
SPR720-202
  • Ages > 18
  • All Genders

Study 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 participants with NTM- PD

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Has a prior diagnosis of NTM-PD due to MAC according to American Thoracic Society (ATS) criteria

  2. Has at least one prior lower respiratory culture (sputum or bronchoalveolar lavage [BAL]) positive for MAC in the 12 months prior to consent

  3. Has an induced sputum culture at Screening positive for MAC by quantitative cultureon solid agar

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

  5. Has a history of successful treatment with sputum culture conversion tonegative

  6. Has recent sputum or BAL culture evidence of recurrent or relapsed disease and

  7. Has been off therapy for at least 3 months prior to consent

  8. Has clinical signs and symptoms within the 6 weeks prior to consent that areconsistent with NTM-PD with ≥2 of the following:

  9. chronic cough

  10. fatigue

  11. frequent throat clearing

  12. shortness of breath (dyspnea)

  13. coughing up of blood (hemoptysis)

  14. excessive mucus (sputum) production

  15. fever (temperature >38ºC or >100.4ºF)

  16. night sweats

  17. loss of appetite

  18. unintended weight loss

  19. wheezing

  20. chest pain

  21. Has a measured forced expiratory volume in the first second following maximalinhalation (FEV1) % predicted ≥30% within 3 months prior to consent. If prior FEV1%predicted test result is not available, obtain FEV1% predicted at Screening toconfirm eligibility

Exclusion

Exclusion Criteria:

  1. In the opinion of the Investigator, is not a candidate for a 5-month delay ininitiation of standard multidrug therapy to participate in a placebo-controlledclinical trial (e.g., participant has severe symptoms or, extensive disease burden)

  2. Has disseminated or extrapulmonary NTM disease

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

  4. Has isolation on lower respiratory (sputum or BAL) cultures of any Mycobacteriumspecies other than those included in MAC within the 6 months prior to consent

  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 allstudy assessments and adherence to the protocol schedule of assessment

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

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

Study Design

Total Participants: 25
Treatment Group(s): 3
Primary Treatment: SPR720 500 mg
Phase: 2
Study Start date:
December 14, 2022
Estimated Completion Date:
December 02, 2024

Connect with a study center

  • Medical Facility

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Medical Facility

    Birmingham 4049979, Alabama 4829764 35233
    United States

    Site Not Available

  • Medical Facility

    Fresno, California 93701
    United States

    Site Not Available

  • Medical Facility

    Los Angeles, California 90033
    United States

    Site Not Available

  • Medical Facility

    Newport Beach, California 92663
    United States

    Site Not Available

  • Medical Facility

    Northridge, California 91324
    United States

    Site Not Available

  • Medical Facility

    Santa Clarita, California 91355
    United States

    Site Not Available

  • Medical Facility

    Fresno 5350937, California 5332921 93701
    United States

    Site Not Available

  • Medical Facility

    Los Angeles 5368361, California 5332921 90033
    United States

    Site Not Available

  • Medical Facility

    Newport Beach 5376890, California 5332921 92663
    United States

    Site Not Available

  • Medical Facility

    Northridge 5377985, California 5332921 91324
    United States

    Site Not Available

  • Medical Facility

    Santa Clarita 5393049, California 5332921 91355
    United States

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  • Medical Facility

    Washington, District of Columbia 20007
    United States

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  • Medical Facility

    Washington D.C. 4140963, District of Columbia 4138106 20007
    United States

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  • Medical Facility

    Kissimmee, Florida 34746-4654
    United States

    Site Not Available

  • Medical Facility

    Loxahatchee Groves, Florida 33470
    United States

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  • Medical Facility

    Miami, Florida 33136
    United States

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  • Medical Facility

    Sebring, Florida 33870
    United States

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  • Medical Facility

    Tampa, Florida 33606
    United States

    Site Not Available

  • Medical Facility

    Kissimmee 4160983, Florida 4155751 34746-4654
    United States

    Site Not Available

  • Medical Facility

    Loxahatchee Groves 4162948, Florida 4155751 33470
    United States

    Site Not Available

  • Medical Facility

    Miami 4164138, Florida 4155751 33136
    United States

    Site Not Available

  • Medical Facility

    Sebring 4172383, Florida 4155751 33870
    United States

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  • Medical Facility

    Tampa 4174757, Florida 4155751 33606
    United States

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    Atlanta, Georgia 30342
    United States

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  • Medical facility

    Atlanta 4180439, Georgia 4197000 30342
    United States

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    Iowa City, Iowa 52242
    United States

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  • Medical Facility

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Site Not Available

  • Medical Facility

    Kansas City, Kansas 66103
    United States

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  • Medical Facility

    Kansas City 4273837, Kansas 4273857 66103
    United States

    Site Not Available

  • Medical Facility

    New Bedford, Massachusetts 02740
    United States

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  • Medical Facility

    New Bedford 4945121, Massachusetts 6254926 02740
    United States

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  • Medical Facility

    Rochester, Minnesota 55905
    United States

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  • Medical Facility

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

  • Medical Facility

    Lebanon, New Hampshire 03756
    United States

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  • Medical Facility

    Lebanon 5088597, New Hampshire 5090174 03756
    United States

    Site Not Available

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    New Hyde Park, New York 11042
    United States

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  • Medical Facility

    New Hyde Park 5128514, New York 5128638 11042
    United States

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    Chapel Hill, North Carolina 27599
    United States

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    Winston-Salem, North Carolina 27103
    United States

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  • Medical Facility

    Chapel Hill 4460162, North Carolina 4482348 27599
    United States

    Site Not Available

  • Medical Facility

    Winston-Salem 4499612, North Carolina 4482348 27103
    United States

    Site Not Available

  • Medical Facility

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Medical Facility

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Site Not Available

  • Medical Facility

    Portland, Oregon 97239
    United States

    Site Not Available

  • Medical Facility

    Portland 5746545, Oregon 5744337 97239
    United States

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  • Medical Facility

    Pittsburgh, Pennsylvania 15213
    United States

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  • Medical Facility

    Pittsburgh 5206379, Pennsylvania 6254927 15213
    United States

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    Charleston, South Carolina 29425
    United States

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  • Medical Facility

    Charleston 4574324, South Carolina 4597040 29425
    United States

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    Denison, Texas 75020
    United States

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  • Medical Facility

    Sherman, Texas 75090
    United States

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  • Medical Facility

    Tyler, Texas 75708
    United States

    Site Not Available

  • Medical Facility

    Denison 4685892, Texas 4736286 75020
    United States

    Site Not Available

  • Medical Facility

    Sherman 4728328, Texas 4736286 75090
    United States

    Site Not Available

  • Medical Facility

    Tyler 4738214, Texas 4736286 75708
    United States

    Site Not Available

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