A report yesterday in the New England Journal of Medicine details detection of highly pathogenic H5N1 avian flu virus in wastewater from 10 Texas cities during the same time period the virus was detected in Texas cattle herds.

The study was conducted by researchers primarily from the University of Texas Health Science Center at Houston (UTHealth Houston) and Baylor College of Medicine. Before March 2024, H5N1 had not been detected in 1,337 wastewater samples analyzed by the team, a press release from UTHealth Houston said. 

From March 4 to July 15 of this year, H5N1 was detected as part of the virome (collection of viruses present in wastewater sample) in 10 of 10 cities, 22 of 23 sites (96%), and 100 of 399 samples (25%). 

"The abundance of H5N1 sequences identified has not correlated with influenza-related hospitalizations, which declined in Texas during the spring of 2024," the authors wrote. 

Overall risk still low 

Texas was the first state this year to confirm an H5N1 case, which involved an agricultural worker on March 28. The case-patient, who presented with conjunctivitis, among other mild symptoms, was exposed to symptomatic cattle. Since that detection, 13 other human US cases have been recorded, and all patients have made recoveries. 

"The widespread detection of influenza A(H5N1) virus in wastewater from 10 U.S. cities is troubling," the authors concluded. "Although the exact origin of the signal is currently unknown, the lack of clinical burden along with genomic information suggests multiple animal sources."

The lack of clinical burden along with genomic information suggests multiple animal sources.

Despite the findings, the risk to human health without direct contact with infected cattle like remains low, the authors said. 

Emergent BioSolutions today announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services, has awarded the company a research and development option worth $41.9 million to its existing contract to further the development and scale-up of its monoclonal antibody treatment for Ebola virus infection.

The 10-year contract for the drug known as Ebanga (ansuvimab-zykl or mAb114) was initially awarded by BARDA in August 2023. 

According to a company statement, the contract option will cover drug substance engineering and scale-up process validation, long-term stability, and commercial readiness in support of its ongoing program for Ebanga. The US Food and Drug Administration (FDA) approved the drug, given as a single infusion, in December 2020 for the treatment of Ebola Zaire virus disease. 

The BARDA activities are part of plan to deploy treatments that can be deployed in outbreaks. The drug was initially developed by Ridgeback Biotherapeutics with support from BARDA. Ridgeback and Emergent signed an agreement that allows Emergent to make and distribute the drug in the United States and Canada.

UK-based biopharmaceutical company F2G today announced a $100 million financing round to advance late-stage development and commercialization of olorofim, a novel oral antifungal therapy for invasive aspergillosis and other invasive fungal infections.

Olorofim is the leading candidate from the orotomide class of antifungals, which work through a different mechanism of action than existing antifungal medications. It's currently being investigated in a phase 2b study in patients who have limited treatment options for rare and difficult-to-treat invasive fungal mold infections such as azole-resistant aspergillosis. Olorofim has received orphan drug status from the European Medicines Agency and the US Food and Drug Administration (FDA) and has been granted Qualified Infectious Disease Product designation by the FDA.

"This is a pivotal period for the company as we conclude the final stages of development and preparation for commercialization of olorofim in the US and elsewhere," F2G CEO Francesco Maria Lavino, MBA, said in a company press release. "If approved, olorofim is expected to be the first of a new class of antifungal agents with a novel, differentiated mechanism of action and will address genuine unmet needs in conditions with high morbidity and mortality."

An 'urgently needed' therapy

The financing round is being led by the AMR Action Fund, which was launched in 2020 with the aim of investing $1 billion to bring new antibiotics and antifungals to the market. AMR Action Fund CEO Henry Skinner, PhD, will join the F2G board of directors.

"For decades, clinicians have relied on a handful of antifungal classes, with few mechanisms of action and significant limitations due to spectrum of activity, drug toxicities, or drug-drug interactions," Skinner said. "These therapies are increasingly failing in patients. We are thrilled to support F2G’s team as they develop this urgently needed therapy and seek regulatory approval."