Cocrystal Pharma Extends Phase 2a Study For Influenza Drug
Cocrystal Pharma extends Phase 2a study of CDI-42344 due to low H3N2 infection rates, ensuring sufficient data.
Breaking News
Jan 01, 2025
Simantini Singh Deo
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Cocrystal Pharma, Inc. has stated its intention to extend the Phase 2a human challenge study of CDI-42344, an oral PB2 inhibitor in progress for multiple influenza strains. The extension has, therefore, been called due to low rates of influenza infection as people exposed to the H3N2 viral strain in the trial session.
The study is a randomized, double-blind, placebo-controlled study conducted at a single centre in the United Kingdom with the objectives of evaluating the safety, tolerability, pharmacokinetic pattern, antiviral efficacy and clinical efficacy of CDI-42344. This drug candidate will be useful as a pill for pandemic avian and seasonal influenza A infections.
Cocrystal began the trial in December of 2023 and later reported in May of 2024 that 78 subjects were enrolled for the trial. However, the relatively low infection rates in the population have led the firm to expand the study to achieve a sufficient sample for assessment.
Sam Lee, Ph.D., Cocrystal’s President and co-CEO, said in a statement, “While CC-42344 showed a favorable safety and tolerability profile, we’re disappointed by the low infectivity rate of the challenge influenza strain used in this study. The establishment of robust influenza infection in healthy, uninfected study subjects is critical to determine clinical endpoints for evaluating antiviral molecules. The low infectivity obtained in this study hindered antiviral data analysis. We remain optimistic about CC-42344 due to its unique mechanism of action with a high barrier to developing resistance, which could render it a best-in-class antiviral treatment for pandemic and seasonal influenza infections.”
He also commented, “We are also encouraged by CC-42344’s favourable safety and tolerability profile from the Phase 2a study to date, with no SAEs and no drug-related discontinuations by study participants. We are working with the clinical research organization to prepare a protocol amendment for approval by the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) in order to extend enrollment in this study and to ensure necessary infection rates among enrolled study subjects.”