Eradivir, a clinical-stage immunotherapy company, launched a Phase 2 challenge study for its antiviral therapeutic, EV25, to evaluate its safety and efficacy against influenza in healthy participants. The study follows a successful Phase 1 trial indicating the drug is well-tolerated. Developed in the lab of Philip Low, Purdue University professor and Eradivir’s chief scientific officer, EV25 is based on a platform technology leveraging small molecules to enhance the immune system’s ability to target and eliminate diseased cells.
This Phase 2 trial is a critical step towards addressing the persistent need for effective influenza treatments. Current antiviral options are limited, and the emergence of drug-resistant strains underscores the urgency for novel approaches. EV25’s potential to address multiple influenza strains, including pandemic and drug-resistant variants, positions it as a promising candidate in the fight against this prevalent and often severe respiratory illness. This advancement could significantly improve patient outcomes by providing a broader spectrum therapeutic.
The Phase 2 challenge study will enroll up to 60 participants. Results from this study, along with the preceding Phase 1 trial, are expected in September. Preclinical studies have shown EV25 to be effective in eliminating the virus in the lungs, even when administered 96 hours post-infection. Eradivir plans to initiate a larger Phase 2b patient study in the U.S. and Europe this fall, contingent on the Phase 2 challenge study results. This subsequent trial will involve approximately 375 participants during the 2025-26 flu season.
Positive results from the Phase 2 study would pave the way for larger clinical trials and potential regulatory approval, bringing EV25 closer to market. This would represent a significant advancement in influenza treatment, potentially offering a more effective and versatile approach to combating the virus. The successful development of EV25 could also validate Eradivir’s BAiT platform, opening doors for the development of similar therapies targeting other viral diseases, including RSV.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
