Eradivir has concluded its Phase IIa clinical trial of EV25 indicating the therapy is well-tolerated and safe, while also significantly alleviating influenza symptoms and reducing viral loads.
These encouraging findings pave the way for a Phase IIb study.
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The first-in-human, double-blind, randomised, placebo-controlled, single ascending dose trial assessed the efficacy, pharmacokinetics, pharmacodynamics, tolerability and safety of EV25.
Part one of the study involved healthy adult subjects, while part two included healthy adults who were inoculated with an attenuated H3N2 influenza virus.
Treatment with a single 300mg dose of EV25 resulted in a marked reduction in the severity and duration of total influenza symptoms, as assessed by the area under the curve (AUC) of FLU-PRO total scores.
Additionally, the treatment had a significant effect on the peak total score and body/systemic scores.
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By GlobalDataEV25 also led to a notable decrease in the number of subjects experiencing lower respiratory tract infections, with 35.7% in the 300mg EV25 group compared to 85.7% in the placebo group, alongside a reduction in the severity of body/systemic symptoms.
A single 300mg dose resulted in a substantial reduction in both infectious and total attenuated H3N2 influenza virus, achieving a 98% decrease in median viral load AUC when compared to the placebo group.
This effect was observed early in the progression of the disease, indicating that EV25 has a rapid influence on the infection.
EV25 was generally well-tolerated and demonstrated a good safety profile, with no observable dose-dependent safety trends.
Eradivir CEO Martin Low said: “We are thrilled that the Phase IIa results showed that EV25 was well tolerated and demonstrated significant reduction in both viral loads and influenza symptoms.
“These results are encouraging and support the continued development of EV25 as a potential treatment for influenza. We look forward to advancing EV25 into a larger Phase IIb trial to further evaluate its efficacy.”
Eradivir will carry out EV25’s Phase IIb study in Europe and the US during the 2026–27 influenza season.
