Viriom plans to extend a Phase I trial investigating its influenza pill AV5124, according to chief science officer Dr David Pauza.
The US-based company announced the completion of the Phase I trial last month. However, the study was conducted by a drug development partner outside of the US.
Viriom wants to do additional research to extend the dose range before committing to a final dose, Pauza told Clinical Trials Arena. The trial is likely to recruit 20-40 healthy volunteers and open sites in Australia.
The data generated from the Phase I trial will lead to an investigational new drug (IND) application with the US Food and Drug Administration (FDA). The company plans to prepare for the Phase II trial during the second quarter of the year and be ready for the flu season in 2024.
AV5124 is a novel inhibitor of influenza virus replication. Laboratory studies have demonstrated that the candidate has a potent suppression of all tested influenza A and influenza B viruses, including drug-resistant variants.
The pill is also a potent inhibitor of highly pathogenic avian influenza viruses circulating in nature. Pauza explained that AV5124’s wild influenza panel even includes circulating variants in dolphins.
Recently, the World Health Organization (WHO) has advised a reversion to trivalent (three-strain) influenza vaccines for the 2024 southern hemisphere influenza season. However, there is a lot of uncertainty for vaccine manufacturers as most produce quadrivalent influenza vaccines.
Entry into Covid-19 arena
Viriom said it also plans to initiate a Phase I trial to investigate its unnamed Coronavirus 3CL protease inhibitor. The study will take place in Australia and will be conducted in Q1 2024.
The Phase I trial will generate dose-ranging information, which will inform plans for a proof-of-concept study, which will likely take place in the US. Due to the unpredictability of the virus, the trial will be located wherever Covid-19 cases are most prevalent at that time, Pauza explained.
Even though the US announced the end of the Covid-19 emergency in February 2023, which was followed by a WHO declaration in May, the clinical trial pipeline for this virus is still very active. Last month, Junshi published new Phase III trial data for its pill VV116, which is already approved in China.
In October, Moderna announced that it will progress its flu and Covid-19 combination vaccine into a Phase III trial, following positive Phase I/II trial data.
