Eradivir Inc., a clinical-stage biotechnology company leveraging the immune system to treat infectious diseases, today announced the successful completion of its Phase 2a clinical trial evaluating EV25, a novel therapy for influenza. The trial demonstrated that EV25 is safe, well-tolerated, and highly effective at reducing both viral loads and influenza symptoms, setting the stage for a larger Phase 2b study to further evaluate its clinical potential.
The first-in-human (FIH), Phase I/2a trial was a placebo-controlled, randomized, double-blind, single-center, single ascending dose (SAD) study designed to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of EV25. The study consisted of two parts:
- Part 1: Healthy adult participants received escalating doses of EV25 to assess safety and PK.
- Part 2: Healthy adults were inoculated with an attenuated H3N2 influenza virus to evaluate EV25’s impact on viral replication and symptom progression.
Key Findings
1. Symptom Reduction Measured by FLU-PRO©
Treatment with a single 300 mg dose of EV25 significantly reduced the duration and severity of influenza symptoms. Key observations included:
- Significant improvement in total FLU-PRO scores, which capture both overall and body/systemic symptom severity.
- A reduction in peak symptom scores compared to placebo.
- Lower incidence of lower respiratory tract infections: 35.7% in the EV25 group versus 85.7% in the placebo group (p=0.0065).
- Marked decrease in body/systemic symptom severity, highlighting the therapy’s potential to improve patient quality of life during influenza infection.
2. Reduction in Viral Load
A single 300 mg dose of EV25 demonstrated a rapid and profound reduction in viral replication:
- 98% decrease in median viral load AUC compared to placebo.
- Early suppression of infectious and total attenuated H3N2 virus, indicating fast-acting antiviral activity.
3. Safety and Tolerability
EV25 was well-tolerated at all tested doses, with no dose-dependent safety trends observed. Adverse events were mild and transient, supporting the therapy’s favorable safety profile for potential single-dose administration.
4. Pharmacokinetics
EV25, delivered via a liquid intranasal spray, was rapidly absorbed, with linear exposures observed across dosing ranges. The PK profile aligns with preclinical predictions and supports the feasibility of a single-dose therapeutic approach for influenza.
“We are thrilled that the Phase 2a results showed EV25 is not only well tolerated but also significantly reduces both viral loads and influenza symptoms,” said Martin Low, CEO of Eradivir. “These findings reinforce our confidence in the potential of EV25 and provide strong rationale for advancing into a Phase 2b trial, where we will further evaluate its efficacy and optimize dosing.”
Next Steps: Phase 2b Clinical Trial
Eradivir plans to initiate the Phase 2b trial during the 2026–2027 influenza season, with study sites in both the United States and Europe. The trial is expected to enroll up to 375 participants and will further assess:
- Efficacy in reducing influenza symptoms across multiple virus strains.
- Optimal dosing for maximal antiviral activity.
- Safety and tolerability in a larger, diverse population.
EV25 and the BAiT Platform
EV25 is built on Eradivir’s proprietary BAiT (Bispecific Antigenic immuno-Therapy) platform, which combines the simplicity of small molecules with the precision and efficacy of antibodies. The platform recruits endogenous antibodies to target viral particles and infected cells, promoting rapid viral clearance. Its modular design allows the platform to be adapted to multiple infectious diseases by modifying the targeting portion of the molecule.
This innovative mechanism positions EV25 as a potential first-in-class treatment for influenza, offering rapid symptom relief, reduced viral shedding, and decreased risk of complications associated with severe infection.
Broader Pipeline
In addition to EV25, Eradivir is advancing other programs targeting highly prevalent viral infections, including:
- Respiratory Syncytial Virus (RSV): Leveraging the BAiT platform to develop treatments for both pediatric and adult populations.
- Dengue Fever: Developing therapies aimed at controlling viral replication and reducing disease severity.
These programs highlight Eradivir’s commitment to immune-targeted, broad-spectrum antiviral therapeutics that address significant unmet medical needs.
Strategic Implications
The success of the Phase 2a trial represents a milestone for Eradivir, validating both the safety and mechanism of action of the BAiT platform. If subsequent trials confirm efficacy, EV25 could provide a new standard of care for influenza, particularly in populations at high risk for severe disease, including the elderly and immunocompromised patients.
By combining rapid symptom relief, viral load reduction, and a favorable safety profile, EV25 addresses critical gaps in current influenza therapy. Moreover, the intranasal route of administration offers a patient-friendly and convenient alternative to existing oral or injectable antivirals.
Conclusion
Eradivir’s Phase 2a results demonstrate that EV25 is a promising therapeutic candidate for influenza, with strong antiviral activity, rapid symptom relief, and a favorable safety and PK profile. The company’s plans to advance into a larger Phase 2b trial during the 2026–2027 flu season will provide critical data to support regulatory discussions and future commercialization.
With the versatility of the BAiT platform, Eradivir is well-positioned to expand its pipeline to other viral diseases, potentially transforming the landscape of immune-based antiviral therapies and improving outcomes for patients worldwide.
