Cocrystal Pharma has selected hVIVO as a contract research organisation (CRO) to carry out a Phase IIa human challenge clinical trial of its oral antiviral candidate, CC-42344, for Influenza A.
The double-blind, single-centre, placebo-controlled trial will analyse the safety, viral and clinical measures of oral CC-42344 in participants who are challenged with influenza A.
Following the United Kingdom Medicines and Healthcare Products Regulatory Agency approval, the trial is anticipated to commence in the second half of next year.
It will be conducted at the facility of hVIVO in the UK.
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Meanwhile, Cocrystal is carrying out a Phase I trial of CC-42344 in healthy participants in Australia.
The company has reported pharmacokinetic (PK) data that support once-a-day dosing of the antiviral from the single-ascending dose segment of this trial.
Subject enrolment in the multiple-ascending dose segment of the trial is underway with the complete trial data anticipated this year.
An oral inhibitor of PB2, CC-42344 hinders a key step of viral replication.
CC-42344 acts on the vital replication enzyme, influenza polymerase, which has numerous regions common to several influenza strains, including pandemic strains.
In in vitro testing, the antiviral showed robust antiviral activity against influenza A strains, including pandemic and seasonal strains with favourable pharmacokinetic and safety profiles.
Cocrystal president and co-interim CEO Sam Lee said: “We are highly encouraged by the Phase I healthy volunteer trial results received so far and are committed to rapidly advancing this programme into a human challenge Phase IIa trial in influenza A-infected subjects.”
“CC-42344 is a broad-spectrum oral PB2 inhibitor that is highly active against drug-resistant influenza A strains.
“Further clinical development of CC-42344 offers an opportunity to address the need.”