Drugs / SPR720
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05966688 | Aug 2023 → Jan 2024 | — | Spero Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT05955586 | Aug 2023 → Feb 2024 | — | Spero Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03796910 | Dec 2018 → Sep 2019 | — | Spero Therapeutics | Completed | No outcome recorded |
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT05496374 | Dec 2022 → Oct 2024 | pulmonary non-tuberculous mycobacterial infection | Spero Therapeutics | Completed | Missed primary |
| Phase 2 | NCT04553406 | Dec 2020 → Jan 2021 | Mycobacterium avium complex disease, pulmonary non-tuberculous mycobacterial infection | Spero Therapeutics | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2024-10-29 | Sperotx | Results Spero Therapeutics Announces SPR720 Phase 2a Interim Results and Provides a Business Update sperotx.com ↗
Phase 2a proof-of-concept study of SPR720 for the treatment of Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD) did not meet its primary endpoint, based on planned interim analysis of 16 patients |
| 2024-10-16 | Sperotx | Results Spero Therapeutics Announces Presentation of SPR719 (Active Moiety of SPR720) In Vitro Data Demonstrating Low Propensity for the Development of Resistance at IDWeek 2024 sperotx.com ↗
The data presented at ID Week 2024 confirm the high potency of SPR719 against both macrolide susceptible and resistant MAC strains, with a low propensity for the spontaneous development of resistance mechanisms. |
| 2024-10-02 | Sperotx | Results Spero Therapeutics Announces Publication of SPR720 Phase 1 Lung Exposure Data in Antimicrobial Agents and Chemotherapy sperotx.com ↗
The results of this Phase 1 study suggest that SPR719 (the active moiety of SPR720) had significant lung uptake and enhanced concentrations in these compartments. |
| 2022-01-04 | Sperotx | Regulatory Spero Therapeutics Announces Lifting of FDA Clinical Trial Hold on SPR720 sperotx.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Phase 2 trial of SPR720, Spero's investigational oral product candidate being developed for nontuberculous mycobacterial (NTM) disease. |
| 2021-02-05 | Sperotx | Regulatory Spero Therapeutics Provides Update on SPR720 Phase 2a Clinical Trial sperotx.com ↗
Spero received verbal notification of the clinical hold for the SPR720 Phase 2a trial but has not yet received written notice from the FDA. |
| 2020-08-31 | Sperotx | Regulatory Spero Therapeutics Announces FDA Acceptance of IND Application for SPR720 sperotx.com ↗
today announced the acceptance by the U.S. Food and Drug Administration (FDA) of Spero's Investigational New Drug application (IND) for SPR720, Spero's oral antimicrobial agent in development for the treatment of nontuberculous mycobacterial (NTM) pulmonary disease. |
| 2020-03-11 | Sperotx | Regulatory Spero Therapeutics Receives FDA Orphan Drug Designation for SPR720 for the Treatment of Nontuberculous Mycobacterial (NTM) Infection sperotx.com ↗
"We are happy to receive this important designation from the FDA, which highlights the critical unmet need that SPR720 is being developed to address," said Ankit Mahadevia, M.D., CEO of Spero Therapeutics. |
| 2019-12-04 | Sperotx | Results Spero Reports Preliminary Findings from Phase 1 Clinical Trial of SPR720 and Announces Plans to Advance Program into Proof-of-Concept Clinical Trial in Patients with NTM Pulmonary Disease sperotx.com ↗
Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multi-drug resistant (MDR) bacterial infections and rare diseases, today announced preliminary findings from a Phase 1 first-in-human clinical trial of SPR720, its oral antimicrobial agent in development for the treatment of nontuberculous mycobacterial (NTM) pulmonary disease. |
| 2019-02-26 | Sperotx | Regulatory Spero Therapeutics Receives QIDP Designation from the U.S. FDA for the Development of SPR720 sperotx.com ↗
We are pleased that the FDA has acknowledged the promise of SPR720 for the treatment of NTM and TB, by granting QIDP status for the compound, |
All press releases naming this drug 14 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SPR720 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05966688 ↗ |
| Action | Inhibit | “bacterial DNA gyrase (GyrB) inhibitor” PMID 34491803 ↗ Sep 2021 |
| Modality | Small molecule | “SPR720 (phosphate prodrug of SPR719) is a novel aminobenzimidazole bacterial DNA gyrase (GyrB) inhibitor” PMID 34491803 ↗ Sep 2021 |
| Route | Oral | “SPR720 administered orally in healthy volunteers” NCT03796910 ↗ |