https://www.cidrap.umn.edu/news-perspective/2022/09/news-scan-sep-22-2022
News Scan for Sep 22, 2022
Antibiotic licensing agreement;
Pathogen research draft recommendations
Filed Under:
Antimicrobial Stewardship;
Biosecurity Issues;
Dual-Use Research
Spero, GSK to partner on oral carbapenem for complicated UTIs
Biopharmaceutical company Spero Therapeutics announced today that it has entered into a licensing agreement with GSK for the antibiotic tebipenem pivoxil hydrobromide (HBr).
Under the agreement, GSK will receive an exclusive license to develop and commercialize the novel oral carbapenem, which is being developed for treatment of complicated urinary tract infections, in all territories except Japan and certain other Asian countries.
"There is a high unmet medical need for a novel oral antibiotic as an alternative to intravenous hospital therapy for drug-resistant complicated urinary tract infections," Luke Miels, MBA, Chief Commercial Officer for GSK, said in a press release.
In April, the Food and Drug Administration (FDA) told Spero that its review of the New Drug Application for tebipenem HBr had identified issues in the phase 3 trial results for the drug and that the data may not support approval. Following that meeting, the company announced that it was stopping all commercialization activities for tebipenem HBr and would reduce its workforce.
The FDA recently told Spero, however, that positive results from an additional phase 3 trial supported by confirmatory nonclinical evidence of efficacy could be sufficient to support approval. The company says it expects to start the trial in 2023.
"Spero's agreement with GSK provides a critical step towards fully realizing the value tebipenem HBr can potentially provide to physicians, payors, and patients," said Spero Chief Executive Officer Ankit Mahadevia, MD.
Sep 22 Spero Therapeutics press release
May 4 CIDRAP News scan
NSABB proposes tighter oversight of certain pathogen research
A federal group that advises the National Institutes of Health (NIH) on biosecurity issues met yesterday to review draft recommendations on experiments with potentially dangerous viruses and other pathogens, which call for tighter scrutiny, according to the Washington Post.
In January, the National Science Advisory Board for Biosecurity (NSABB) met for the first time since 2020, during which the NIH asked the group to review government policies for work on potentially dangerous pathogens. The NIH asked the panel to look at both gain-of-function (GOF) studies and dual-use research of concern—or studies that could be used for both good or ill. In taking on the task, the NSABB formed two working groups and held listening sessions.
According to the Post, advisers in their draft report urge the government to broaden its definition of the kinds of experiments that require special review and safety measures to include pathogens that are a public health or national security threat. Current policies more narrowly focus on deadlier pathogens. Though the report doesn't single out SARS-CoV-2, the broader focus would include disruptive but less deadly threats.
Finalized recommendations aren't expected for the next several months. In 2012, the NSABB was instrumental in making recommendations about publishing controversial H5N1 avian flu transmission GOF studies. Then in 2016, the White House asked the group to recommend guidance on assessing and funding GOF studies.
Sep 21 Washington Post story
NSABB draft recommendations
News Scan for Sep 22, 2022
Antibiotic licensing agreement;
Pathogen research draft recommendations
Filed Under:
Antimicrobial Stewardship;
Biosecurity Issues;
Dual-Use Research
Spero, GSK to partner on oral carbapenem for complicated UTIs
Biopharmaceutical company Spero Therapeutics announced today that it has entered into a licensing agreement with GSK for the antibiotic tebipenem pivoxil hydrobromide (HBr).
Under the agreement, GSK will receive an exclusive license to develop and commercialize the novel oral carbapenem, which is being developed for treatment of complicated urinary tract infections, in all territories except Japan and certain other Asian countries.
"There is a high unmet medical need for a novel oral antibiotic as an alternative to intravenous hospital therapy for drug-resistant complicated urinary tract infections," Luke Miels, MBA, Chief Commercial Officer for GSK, said in a press release.
In April, the Food and Drug Administration (FDA) told Spero that its review of the New Drug Application for tebipenem HBr had identified issues in the phase 3 trial results for the drug and that the data may not support approval. Following that meeting, the company announced that it was stopping all commercialization activities for tebipenem HBr and would reduce its workforce.
The FDA recently told Spero, however, that positive results from an additional phase 3 trial supported by confirmatory nonclinical evidence of efficacy could be sufficient to support approval. The company says it expects to start the trial in 2023.
"Spero's agreement with GSK provides a critical step towards fully realizing the value tebipenem HBr can potentially provide to physicians, payors, and patients," said Spero Chief Executive Officer Ankit Mahadevia, MD.
Sep 22 Spero Therapeutics press release
May 4 CIDRAP News scan
NSABB proposes tighter oversight of certain pathogen research
A federal group that advises the National Institutes of Health (NIH) on biosecurity issues met yesterday to review draft recommendations on experiments with potentially dangerous viruses and other pathogens, which call for tighter scrutiny, according to the Washington Post.
In January, the National Science Advisory Board for Biosecurity (NSABB) met for the first time since 2020, during which the NIH asked the group to review government policies for work on potentially dangerous pathogens. The NIH asked the panel to look at both gain-of-function (GOF) studies and dual-use research of concern—or studies that could be used for both good or ill. In taking on the task, the NSABB formed two working groups and held listening sessions.
According to the Post, advisers in their draft report urge the government to broaden its definition of the kinds of experiments that require special review and safety measures to include pathogens that are a public health or national security threat. Current policies more narrowly focus on deadlier pathogens. Though the report doesn't single out SARS-CoV-2, the broader focus would include disruptive but less deadly threats.
Finalized recommendations aren't expected for the next several months. In 2012, the NSABB was instrumental in making recommendations about publishing controversial H5N1 avian flu transmission GOF studies. Then in 2016, the White House asked the group to recommend guidance on assessing and funding GOF studies.
Sep 21 Washington Post story
NSABB draft recommendations