1. Scrip
  2. >>R&D
  3. >>Clinical Trials

Entasis Anticipates First FDA Approval Of Pathogen-Specific Antibacterial

 
• By Joseph Haas

With Phase III data showing non-inferiority to colistin, as well as nephrotoxicity superiority, Entasis thinks sulbactam/durlobactam will provide a new standard of care and succeed where Achaogen’s Zemdri failed.

Antibiotic-resistant-bacteria
Entasis tested its combo antibacterial against colistin

Entasis Therapeutics Holdings Inc. thinks the Phase III data for its combination anti-infective therapy SUL-DUR against carbapenem-resistant Acinetobacterbaumannii infections will position it to earn the first pathogen-specific indication for an antibiotic and enable it to succeed where Achaogen, Inc.’s Zemdri (plazomicin) failed several years earlier.

Entasis, which spun out from AstraZeneca PLC in 2015, reported top-line Phase III data on 18 October showing non-inferiority...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

Biogen Lays Out Cadence For Felzartamab Data In Kidney Diseases

 
• By Jessica Merrill

The first Phase III data for the CD38-targeting antibody is expected in 2027 in antibody-mediated rejection in kidney transplant patients, followed by other indications.

In Brief: Gilead HIV Trials On Hold Over Safety Signal

 
• By Sushmita Panda

The FDA has paused Gilead’s HIV trials of GS-1720 and GS-4182 over safety concerns. The company’s upcoming PrEP PDUFA looks to be unaffected.

Spain’s SpliceBio Secures Sanofi and Roche Support In $135m Financing

 
• By Kevin Grogan

Series B cash will be used to advance its Stargardt disease gene therapy.

In Brief: PolyPid’s D-PLEX100 Aces Phase III Trial, US Partner, Submission Eyed

 
• By Sushmita Panda

PolyPid's D-PLEX100 meets Phase III endpoints this time around, significantly reducing surgical point infections in abdominal colorectal surgery, and is set for a US approval submission early next year.

More from R&D

In Brief: PolyPid’s D-PLEX100 Aces Phase III Trial, US Partner, Submission Eyed

 
• By Sushmita Panda

PolyPid's D-PLEX100 meets Phase III endpoints this time around, significantly reducing surgical point infections in abdominal colorectal surgery, and is set for a US approval submission early next year.

Insmed’s PAH Data Indicate Potential To Surpass Established Therapies

 
• By Joseph Haas

Insmed’s inhaled treprostinil exceeded goals for reducing pulmonary vascular resistance and improving six-minute walk test distance in Phase IIb data.

NewAmsterdam’s CETP Inhibitor Improves Alzheimer’s Biomarkers

 
• By Mandy Jackson

Data from the BROADWAY trial testing LDL-C reduction in adults with ASCVD showed that obicetrapib improved Alzheimer’s disease biomarkers, including tau and amyloid. Analysts think the data could differentiate obicetrapib against competitors in the cholesterol market.