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Details:
SPR994 (tebipenem pivoxil hydrobromide) is an oral antibiotic which is under phase 3 clinical development for the treatment of patients with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP).
Lead Product(s): Tebipenem Pivoxil Hydrobromide
Therapeutic Area: Infections and Infectious Diseases Product Name: SPR994
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 02, 2024
Details:
SPR994 is Spero’s novel late-stage development asset, an oral formulation tablet of tebipenem pivoxil hydrobromide, a carbapenem antibiotic of the β-lactam class.
Lead Product(s): Tebipenem Pivoxil Hydrobromide
Therapeutic Area: Infections and Infectious Diseases Product Name: SPR994
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 31, 2023
Details:
Under the terms of the agreement, Spero is responsible for the execution and costs of Phase 3 trial of tebipenem HBr (tebipenem pivoxil hydrobromide), an investigational drug, is being developed as the potentially first oral carbapenem antibiotic for the treatment of cUTI.
Lead Product(s): Tebipenem Pivoxil Hydrobromide
Therapeutic Area: Infections and Infectious Diseases Product Name: Tebipenem HBr
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: GSK
Deal Size: $591.0 million Upfront Cash: $66.0 million
Deal Type: Licensing Agreement November 08, 2022
Details:
Under the licence agreement, Spero will be responsible for the execution and costs of the remaining phase III trial of tebipenem HBr. GSK will be responsible for the execution and costs of additional clinical development, including regulatory submission and commercialisation.
Lead Product(s): Tebipenem Pivoxil Hydrobromide
Therapeutic Area: Infections and Infectious Diseases Product Name: SPR994
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: GSK
Deal Size: $816.0 million Upfront Cash: $66.0 million
Deal Type: Licensing Agreement September 22, 2022
Details:
FDA feedback indicates positive results from a single additional Phase 3 clinical trial in patients with complicated urinary tract infection (cUTI), with supportive confirmatory evidence of efficacy could support approval of SPR994 (tebipenem HBr).
Lead Product(s): Tebipenem Pivoxil Hydrobromide
Therapeutic Area: Infections and Infectious Diseases Product Name: SPR994
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 06, 2022
Details:
Spero’s lead product candidate, tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994), is being developed as the first oral carbapenem antibiotic for use in cUTI, including pyelonephritis.
Lead Product(s): Tebipenem Pivoxil Hydrobromide
Therapeutic Area: Infections and Infectious Diseases Product Name: SPR994
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 28, 2021
Details:
Spero intends to use the proceeds from the agreement for launch of tebipenem HBr, for a complicated urinary tract infection (cUTI) indication as well as to support the continued clinical development of SPR720 and SPR206.
Lead Product(s): Tebipenem Pivoxil Hydrobromide
Therapeutic Area: Infections and Infectious Diseases Product Name: SPR994
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: HealthCare Royalty Partners
Deal Size: $125.0 million Upfront Cash: Undisclosed
Deal Type: Financing September 30, 2021
Details:
Presentations will showcase in vitro and in vivo studies of tebipenem HBr for treatment of adults with complicated urinary tract infection (cUTI) and acute pyelonephritis (AP) and highlight additional research on the epidemiology and management of cUTI.
Lead Product(s): Tebipenem Pivoxil Hydrobromide
Therapeutic Area: Infections and Infectious Diseases Product Name: SPR994
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 16, 2021
Details:
Pivotal Phase 3 clinical trial of oral tebipenem HBr met primary endpoint, demonstrating statistical non-inferiority versus intravenous ertapenem in patients with complicated urinary tract infection and acute pyelonephritis.
Lead Product(s): Tebipenem Pivoxil Hydrobromide
Therapeutic Area: Infections and Infectious Diseases Product Name: SPR994
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 08, 2020
Details:
Phase 3 clinical trial, ADAPT-PO, is evaluating tebipenem HBr for the treatment of complicated urinary tract infection (cUTI) and acute pyelonephritis (AP).
Lead Product(s): Tebipenem Pivoxil Hydrobromide
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 05, 2020
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