Eradivir, a clinical-stage small molecule immunotherapy biotech company, announced it has begun a Phase 2 challenge study with its antiviral therapeutic, EV25. The study will provide safety and efficacy data gathered from otherwise healthy participants infected with influenza then later treated with EV25.
EV25 was built on a platform created in Philip Low's lab. Low is the Presidential Scholar for Drug Discovery and the Ralph C. Corley Distinguished Professor of Chemistry in Purdue University's College of Science. Low is Eradivir's chief scientific officer and on its board of directors.
The European Medicines Agency and Belgium's Federal Agency for Medicines and Health Products approved the Phase 2 challenge study after the successful completion of a Phase 1 study on EV25. Based on the preliminary Phase 1 safety results, a safety review committee comprising study staff and independent physicians concluded the compound was well tolerated by participants.
Martin Low, CEO of Eradivir, said the company is moving quickly to the challenge study because of its confidence in EV25.
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. 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. Our preclinical research was recently published in the peer-reviewed Nature Communications and Proceedings of the National Academy of Sciences."
Martin Low, CEO of Eradivir
Up to 60 people will be tested in the Phase 2 challenge study, which will provide preliminary data on EV25's efficacy against influenza and confirm its safety. Data from both the Phase 1 and Phase 2 challenge studies will be available in September.
Pending the results of the challenge study, a Phase 2b patient study will begin in the U.S. and Europe this fall at the beginning of the 2025-26 flu season. This larger study will include about 375 participants.
Purdue connections
Philip Low is on the faculty of the Purdue Institute for Drug Discovery and the Purdue Institute for Cancer Research. Low's research supports Purdue's One Health mission, which drives innovation at the intersection of human, animal and plant health.
Eradivir is a Purdue Strategic Ventures portfolio company.
Bovine H5N1 influenza shows potential for human adaptation through key mutations