Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SPR720 · 3 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Investigator Blind: Placebo | PLACEBO_COMPARATOR | Participants received SPR720 matching-placebo capsules, orally, once daily (QD) for 56 days. |
| 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. |
| Investigator Blind: SPR720 1000 mg | EXPERIMENTAL | Participants received SPR720 1000 mg (250 mg × 4) capsules, orally, QD for 56 days. |
| Open-label: SPR720 1000 mg | EXPERIMENTAL | Participants received SPR720 1000 mg (250 mg × 4) capsules, orally, QD for 56 days. |
| Open-label: SPR720 500 mg | EXPERIMENTAL | Participants received SPR720 500 mg (250 mg × 2) capsules, orally, twice daily (BID) for 56 days. |
| SPR720 1000 mg | EXPERIMENTAL | Healthy participants will receive SPR720 1000 milligrams (mg), orally, once daily (QD) for 7 days. |
| Azithromycin 500 mg | EXPERIMENTAL | Healthy participants will receive azithromycin 500 mg, orally, QD for 7 days. |
| Ethambutol 800 mg | EXPERIMENTAL | Healthy participants will receive ethambutol 800 mg, orally, QD for 7 days. |
| SPR720 1000 mg + Azithromycin 500 mg + Ethambutol 800 mg | EXPERIMENTAL | Healthy participants will be co-administered SPR720 1000 mg, azithromycin 500 mg, and ethambutol 800 mg, orally, QD for 7 days. |
| Azithromycin 500 mg + Ethambutol 800 mg | EXPERIMENTAL | Healthy participants will be co-administered azithromycin 500 mg, and ethambutol 800 mg, orally, QD for 7 days. |
| SPR720 | EXPERIMENTAL | Healthy participants will receive SPR720 1000 mg capsule, orally, for 7 days. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo-matching capsules was administered orally. |
| SPR720 500 mg | DRUG | SPR720 500 mg (250 mg × 2 capsules) was administered orally. |
| SPR720 1000 mg | DRUG | SPR720 500 mg (250 mg × 4 capsules) was administered orally. |
| SPR720 | DRUG | Multiple oral doses of SPR720 capsules. |
| Azithromycin | DRUG | Multiple oral doses of azithromycin. |
| Ethambutol | DRUG | Multiple oral doses of ethambutol. |
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 ...
SPR720 is an investigational small molecule being studied for the treatment of Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD), specifically Mycobacterium Avium Complex (MAC) pulmonary disease. It has also been evaluated in healthy volunteers for pharmacokinetic studies. SPR720 is not approved and remains in clinical development.
SPR720 is being developed by Spero Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker SPRO. The company is conducting clinical trials to evaluate the drug's efficacy, safety, and pharmacokinetics in patients with NTM-PD and in healthy volunteers.
SPR720 has completed Phase 1 and Phase 2 clinical trials. The Phase 2 study evaluated its efficacy and safety in patients with MAC pulmonary disease, while Phase 1 studies assessed pharmacokinetics in healthy volunteers. SPR720 is investigational and has not received FDA approval.
SPR720 has been studied in three completed trials: NCT05496374 (Phase 2, efficacy and safety in MAC pulmonary disease, 25 participants), NCT05955586 (Phase 1, intrapulmonary pharmacokinetics in healthy volunteers, 33 participants), and NCT05966688 (Phase 1, drug interaction study in healthy volunteers, 39 participants).
SPR720 is a small molecule that targets bacterial DNA gyrase, an enzyme essential for bacterial DNA replication. By inhibiting this target, SPR720 aims to treat infections caused by Mycobacterium Avium Complex. This mechanism is being evaluated in clinical trials for NTM-PD.