AMR

Promising C. difficile drug ridinilazole has failed in Phase 3, CARB-X grantee Summit Therapeutics announced Monday.

The Massachusetts-based company said the study showed that the investigational drug resulted in a higher observed Sustained Clinical Response rate than current standard-of-care vancomycin “but did not meet the study’s primary endpoint for superiority.”

The company did see a “meaningful reduction in recurrence,” however, which Summit Therapeutics linked to the…

The Access to Medicine (AtM) Foundation has released its 2021 antimicrobial resistance benchmark report evaluating 17 of the industry’s most active players in the AMR space.

GSK maintained its lead among multinational corporations, although Pfizer leaped from sixth to a close second place after making “significant strides” in stewardship, waste management, drug access, R&D and data sharing. The AtM Foundation praised Pfizer as the only major multinational making its raw data…

What role can vaccines play in combatting antimicrobial resistance? A public-private partnership seeks to answer that question through an open-source, web-based analytic platform, Germany’s European Vaccine Initiative (EVI) announced last week.

The PrIMAVeRa project—coordinated by EVI and backed by $10.3 million from the Brussels-based Innovative Medicines Initiative—joins GSK, Janssen and Pfizer with 16 academic and SME partners across the E.U., Russia and the U.K.

The five-year…

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Venatorx Pharmaceuticals announced Monday that it has entered into a licensing agreement with Roche to advance drug treatments for infections caused by carbapenem-resistant Enterobacterales (CRE) bacteria.

Boston University-led nonprofit CARB-X gave the Pennsylvania-based company $15 million between 2019 and 2020 to develop a new class of oral antibiotics to treat infections caused by multidrug-resistant N. gonorrhoeae.

Entasis Therapeutics’ investigational sulbactam-durlobactam (SUL-DUR) antibiotic was non-inferior versus standard colistin at preventing 28-day all-cause mortality in people with carbapenem-resistant A. baumannii infections, the Massachusetts-based biotech announced Monday, citing new Phase 3 data. The topline results also showed that SUL-DUR patients had higher clinical cure rates and lower rates of nephrotoxicity compared to those receiving the last-resort polymyxin-class antibiotic, per…

The Lancet Microbe published an article last week by European academics arguing that funding for antibiotic innovation remains “insufficient to address the scale of antibiotic resistance.” As an alternative, the authors proposed a “mission-oriented” antibiotic trials infrastructure to protect new drugs from commercial failure.

Through the so-called Networked Institute Model (NIM), a collection of public institutes would conduct all stages of antibiotic clinical trials, negotiate…

A therapy for the prevention of recurrent C. difficile infection (CDI) in high-risk patients has met the primary endpoint in a Phase 2 trial, Vedanta Biosciences announced Tuesday. The Massachusetts-based company’s VE303, an orally administered live biotherapeutic, yielded a 31.7% absolute risk reduction in rate of recurrence versus placebo, according to a press release.

Based on the Phase 2 data, the U.S. Biomedical Advanced Research and Development Authority (BARDA) exercised an…

A new nonprofit—dubbed the Incubator for Antibacterial Therapies in Europe (INCATE)—will support the European-based development of novel therapies, diagnostics and interventions to combat antimicrobial resistance. A Novo Holdings REPAIR Impact Fund director announced the incubator’s launch Sunday in a LinkedIn post.

INCATE’s support—a mix of consulting, business networking, and up to approximately $290,000 in non-dilutive funding (for selected projects)—aims to bring companies to “an…

Basilea Pharmaceutica announced Monday that the U.S. Biomedical Advanced Research and Development Authority has increased its total investment in the Swiss company’s ceftobiprole antibiotic candidate to $134.2 million.

The new tranche of $4.3 million will support a Phase 3 trial to evaluate the intravenous drug as an S. aureus bacteremia treatment, the press release said.

The Basel-based company won funding from CARB-X in May to develop a novel class of antibiotics against drug-…

Europe’s public-private Innovative Medicines Initiative (IMI) announced last week the launch of UNITE4TB—a $218 million, seven-year project to accelerate and improve the clinical evaluation of combinations of existing and novel drugs as treatment regimens for drug-resistant and drug-sensitive tuberculosis. UNITE4TB is the newest project of IMI’s AMR Accelerator.

The consortium—which involves 30 partners including academic institutions, GSK, J&J’s Janssen subsidiary, KNCV…

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