Study Demonstrates EV25’s Safety, Tolerability and Efficacy in Reducing Viral Load and Symptoms
WEST LAFAYETTE, Ind.–(BUSINESS WIRE)–Eradivir Inc., a clinical-stage biotechnology company that targets the power of the immune system to treat disease, today announced the successful completion of its Phase 2a clinical trial for EV25, a therapy for the treatment of influenza. The study demonstrated that EV25 is safe, well-tolerated and significantly reduces viral loads and influenza symptoms, paving the way for a larger Phase 2b trial.
The First-In-Human (FIH), Phase I/2a, placebo-controlled, randomized, double-blind, single-center, single ascending dose (SAD) study evaluated the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of EV25. The study consisted of two parts: Part 1 involved healthy adult participants, and Part 2 involved healthy adult participants inoculated with an attenuated H3N2 influenza virus. Key findings included:
- FLU-PRO© Symptom Score Reduction: Treatment with a single 300 mg dose of EV25 demonstrated a significant reduction in total influenza symptom duration and severity as measured by AUC of FLU-PRO total scores, as well as a significant impact on peak total score and body/systemic scores. It also demonstrated a significant decrease in the number of participants with lower respiratory tract infection (35.7% in 300 mg EV25 vs 85.7% in the placebo group, p=0.0065), and a decrease in body/systemic symptom severity.
- Reduction in Viral Loads: A 300 mg single dose of EV25 significantly decreased the amount of infectious and total attenuated H3N2 influenza virus, with a 98% decrease in median viral load AUC compared to placebo. This large difference occurred early in the disease time course, suggesting EV25 has a rapid impact on the disease.
- Safety and Tolerability: EV25 was generally safe and well-tolerated with no dose dependent safety trends.
- Pharmacokinetics: EV25 was quickly absorbed via a liquid intranasal spray. The exposures were linear between doses and well predicted by preclinical models. The PK profiles measured are supportive of a single dose therapy for treating influenza.
“We are thrilled that the Phase 2a results showed that EV25 was well tolerated and demonstrated significant reduction in both viral loads and influenza symptoms,” said Martin Low, Eradivir Chief Executive Officer. “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 2b trial to further evaluate its efficacy.”
Eradivir will conduct EV25’s Phase 2b study in both the United States and Europe in conjunction with the 2026-2027 influenza season. This larger study is expected to include up to 375 participants and further evaluate EV25’s efficacy and dosing.
EV25 was built on Eradivir’s BAiT (Bispecific Antigenic immuno-Therapy) platform that combines the simplicity of small molecules with the efficacy of antibodies. Eradivir’s technology recruits endogenous antibodies to target virus and infected cells to clear the disease. By altering the targeting portion of the molecule, the platform can be leveraged to treat a myriad of diseases.
In addition to EV25, the company is currently evaluating other candidates for the treatments of Respiratory Syncytial Virus (RSV), and Dengue Fever.
ABOUT ERADIVIR
Eradivir Inc. is a privately held, clinical-stage biotechnology company that focuses the power of the immune system to treat viral infections and other diseases. Its proprietary BAiT platform (Bispecific Antigenic immuno-Therapy) combines the simplicity of small molecule therapies with the efficacy of antibody therapies to facilitate rapid and selective diseased cell destruction. Eradivir’s lead antiviral therapeutic EV25 recently completed a successful Phase 2a study and will enter a Phase 2b study in the Fall of 2026. Eradivir’s second drug EV148, a therapy for RSV, is planned for entry into the clinic at the end of 2026. For more information about the company and its latest news, visit www.eradivir.com.
Contacts
Media and Partner Contact
Martin Low
martin.low@eradivir.com