AN2 Therapeutics Inc.’s decision to pause enrollment in the phase III portion of its phase II/III testing epetraborole in treatment-refractory Mycobacterium avium complex lung disease, citing potentially lower-than-expected efficacy from a blinded aggregate analysis of the phase II portion, left analysts and investors with little to do but speculate on the program’s viability going forward.
GSK plc has announced it has stopped early two pivotal phase III trials of its urinary tract infection drug, gepotidacin, for efficacy and is preparing regulatory filings for what could be the first new oral antibiotic for the disease in more than 20 years.
Spero Therapeutics Inc. has come out swinging after a U.S. FDA rejection for its oral antibiotic, tebipenem Hbr, picking up a potential $600 million licensing deal with pharma giant GSK plc after agreeing on a plan with the regulator to revive the drug.
Spero Therapeutics Inc.’s oral antibiotic, tebipenem Hbr, has been rejected by the U.S. FDA for adults with complicated urinary tract infection, after the regulator said a further trial is needed for approval.
Executives of Spero Therapeutics Inc. evaded analysts’ attempts to clarify “deficiencies” noted by the U.S. FDA in its ongoing review of the company’s NDA seeking approval of oral carbapenem antibiotic tebipenem HBr for complicated urinary tract infections (cUTIs), emphasizing instead that they have three months to work with the regulator ahead of a June 27 PDUFA date assigned to the application.
Anti-infective drugs approved over the last two decades were able to get through the clinical development and FDA approval processes substantially faster than other drugs, according to a new report from the Tufts Center for the Study of Drug Development.
Two phase III stumbles of Iterum Therapeutics plc’s sulopenem have cast the company’s future in doubt. The latest problem is the failure of the penem anti-infective compound, with oral and I.V. formulations, failing to achieve statistical noninferiority relative to ertapenem in treating complicated urinary tract infection (cUTI).
The public attention that COVID-19 has received has spilled over to antibiotics companies, and the BioWorld Infectious Diseases index has grown 14% in value since the beginning of the year.
There has been a flurry of news flowing from companies developing new antibiotics during the month and the BioWorld Infectious Diseases index, after languishing for the past several months, is tracking up 5% for October. The activity comes against the backdrop of the completion of the AMR Challenge.