Eradivir, Inc., a clinical-stage biotech company developing antibody-recruiting small molecules to treat disease, today announced the dosing of the first patient with influenza in a Phase 2 study evaluating EV25 in adults with naturally occurring influenza infection in Bangladesh. The safety lead-in portion of the study was completed last month, with EV25 being well tolerated across all cohorts. The study marks the first evaluation of EV25 in patients with naturally occurring (wild type) influenza infection.
The randomized, double-blind Phase 2 study is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of a single subcutaneous dose of EV25 in adults with uncomplicated influenza. The study includes comparisons of three dose levels of EV25 to placebo and oseltamivir and is designed to assess the impact of treatment in patients presenting up to 72 hours post symptom onset, with an exploratory arm treating patients who present at later timepoints.
According to the World Health Organization, seasonal influenza causes an estimated one billion infections annually, including three to five million cases of severe illness and up to 650,000 respiratory deaths worldwide. While antiviral treatments are available, many patients seek care after symptoms have already progressed, highlighting the need for new treatment options that may remain effective later in the course of infection.
Eradivir is conducting the study in collaboration with icddr,b, an international health research institute based in Bangladesh, with extensive experience in influenza, surveillance, infectious disease research, and clinical trials. The study is being conducted with the support of relevant health and regulatory authorities in Bangladesh.
“This study marks an important step in evaluating EV25 in patients with naturally occurring influenza infection,” said Martin Low, Chief Executive Officer of Eradivir. “By working with icddr,b, we are able to evaluate EV25 in a real-world setting where seasonal influenza remains an important public health challenge, which we believe will provide important insights for future clinical development, especially as it relates to treating later stage infection.”
ABOUT ERADIVIR
Eradivir, Inc. is a privately held, clinical-stage biotech company developing antibody-recruiting small molecules to treat disease. Using its proprietary BAiT™ (Bispecific Antigenic immuno-Therapy) platform, the company is advancing a pipeline of investigational antibody-recruiting small molecules, including lead therapeutic EV25 for influenza and EV148 for RSV, with additional candidates in the pipeline targeting multiple diseases. For more information about the company and its latest news, visit www.eradivir.com.
ABOUT EV25
EV25 was developed on Eradivir’s proprietary Bispecific Antigenic immuno-Therapy (BAiT™) platform. In previous clinical studies, EV25 was generally well tolerated and showed significant reductions in viral load and symptoms in a controlled human influenza challenge study. Unlike conventional antivirals that directly inhibit viral replication, EV25 is designed to bind to infected cells and virions and recruit existing circulating antibodies, triggering rapid and targeted natural antibody immune clearance. Because this antibody-recruiting mechanism works independently of viral replication, EV25 has the potential to treat both early- and late-stage infections.
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