Eradivir, a clinical-stage biotech company focused on small molecule immunotherapy, has commenced a Phase 2 challenge study for its promising antiviral therapeutic EV25 against influenza. The study, approved by the European Medicines Agency and Belgium's Federal Agency for Medicines and Health Products, will assess both safety and efficacy in healthy volunteers deliberately infected with influenza.
The advancement to Phase 2 follows successful completion of a Phase 1 study where a safety review committee, comprising study staff and independent physicians, determined that EV25 was well-tolerated by participants.
"We have conducted over 150 preclinical studies with EV25, which demonstrated its ability to quickly eliminate the virus in the lungs even when taken 96 hours postinfection," said Martin Low, CEO of Eradivir. "These studies have also shown EV25's ability to treat several flu strains, including pandemic strains and those resistant to current flu drugs. We have been able to positively differentiate EV25 across several other parameters from currently available therapies."
Novel Mechanism of Action
EV25 was developed using the BAiT platform (Bispecific Antigenic immuno-Therapy) created in the laboratory of Philip Low, Presidential Scholar for Drug Discovery and Ralph C. Corley Distinguished Professor of Chemistry at Purdue University. Low serves as Eradivir's chief scientific officer and sits on its board of directors.
The BAiT platform leverages small molecules to tether a patient's immune cells specifically to diseased cells, facilitating their rapid and selective destruction. This approach represents a potentially significant advancement over existing influenza therapies by harnessing the body's own immune system to target infected cells.
Study Design and Timeline
The Phase 2 challenge study will involve up to 60 healthy participants who will be deliberately infected with influenza and subsequently treated with EV25. This controlled environment allows researchers to precisely measure the therapeutic's impact on viral load, symptom duration, and overall safety profile.
Data from both the Phase 1 and Phase 2 challenge studies are expected to be available in September 2025. Pending positive results, Eradivir plans to initiate a larger Phase 2b patient study in the United States and Europe coinciding with the 2025-26 flu season, which will include approximately 375 participants.
Addressing Unmet Needs in Influenza Treatment
Influenza remains a significant global health burden, causing an estimated 3-5 million cases of severe illness and 290,000-650,000 respiratory deaths worldwide annually. Current antiviral treatments for influenza, such as neuraminidase inhibitors and polymerase inhibitors, face challenges including limited efficacy when not administered early in infection and emerging viral resistance.
The preclinical research for EV25, recently published in Nature Communications and Proceedings of the National Academy of Sciences, suggests potential advantages over existing therapies. Notably, EV25 demonstrated efficacy even when administered 96 hours after infection—a significant improvement over current treatments that must typically be given within 48 hours of symptom onset to be effective.
Additionally, EV25 has shown activity against multiple influenza strains, including pandemic variants and those resistant to current antiviral medications, potentially addressing a critical gap in the treatment landscape.
Purdue University Connection
Eradivir represents a successful technology transfer from academic research to clinical development. The company is a Purdue Strategic Ventures portfolio company, with the foundational technology emerging from research at Purdue University.
Philip Low's research at Purdue supports the university's One Health mission, which drives innovation at the intersection of human, animal, and plant health. Low holds positions at both the Purdue Institute for Drug Discovery and the Purdue Institute for Cancer Research.
Future Directions
Beyond influenza, Eradivir is developing additional therapies based on the BAiT platform for other viral infections, including respiratory syncytial virus (RSV). EV25 represents the company's first drug candidate to enter human clinical trials.
The results of the current Phase 2 challenge study will be closely watched by infectious disease specialists and the pharmaceutical industry as a potential new approach to treating viral respiratory infections, particularly those with pandemic potential.
