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SPR720

Phase 2

Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD) | Small molecule | Infectious Disease |Spero Therapeutics, Inc.|Last Updated: Oct 9, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05496374A 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 DiseasePHASE2 COMPLETED 25Dec 14, 2022Dec 2, 2024Oct 9, 202528 United States
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Study Endpoints
Primary Endpoints
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 Endpoints
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)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Investigator Blind: PlaceboPLACEBO_COMPARATORParticipants received SPR720 matching-placebo capsules, orally, once daily (QD) for 56 days.
Investigator Blind: SPR720 500 mgEXPERIMENTALParticipants received SPR720 500 mg (250 mg × 2) capsules along with 2 SPR720 matching- placebo capsules, orally, QD for 56 days.
Investigator Blind: SPR720 1000 mgEXPERIMENTALParticipants received SPR720 1000 mg (250 mg × 4) capsules, orally, QD for 56 days.
Open-label: SPR720 1000 mgEXPERIMENTALParticipants received SPR720 1000 mg (250 mg × 4) capsules, orally, QD for 56 days.
Open-label: SPR720 500 mgEXPERIMENTALParticipants received SPR720 500 mg (250 mg × 2) capsules, orally, twice daily (BID) for 56 days.
Interventions
NameTypeDescription
PlaceboDRUGPlacebo-matching capsules was administered orally.
SPR720 500 mgDRUGSPR720 500 mg (250 mg × 2 capsules) was administered orally.
SPR720 1000 mgDRUGSPR720 500 mg (250 mg × 4 capsules) was administered orally.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites28

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 ...

Countries:United States
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