The therapy is developed as a potential treatment for both pandemic avian and seasonal influenza A infections. Credit: Yurii_Yarema / Shutterstock.

Cocrystal Pharma has announced its intent to extend enrolment for its Phase IIa human challenge trial of the oral influenza polymerase basic 2 (PB2) inhibitor, CC-42344, following unpredictable low infection rates among participants, especially challenged with the strain of Influenza A Virus (H3N2).

The randomised, placebo-controlled trial, conducted at a single site in the UK, aims to assess the therapy’s tolerability, safety, antiviral activity, clinical measurements, and pharmacokinetics.

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Being developed as a potential treatment for both pandemic avian and seasonal influenza A infections, CC-42344 claims to have demonstrated ‘excellent’ in vitro antiviral activity against a range of influenza A strains, including those resistant to existing treatments such as Xofluza and Tamiflu.

In December 2023, the company reported the enrolment of the first subject in this trial, with a complete enrolment of 78 participants announced last May. Its ‘structure-based drug discovery platform’ technology was instrumental in the discovery of CC-42344.

Cocrystal Pharma president and co-CEO Sam Lee said: “While CC-42344 showed a favourable safety and tolerability profile, we’re disappointed by the low infectivity rate of the challenge influenza strain used in this study.

“We are working with the clinical research organisation to prepare a protocol amendment for approval by the UK MHRA in order to extend enrolment in this study, and to ensure necessary infection rates among enrolled study subjects.”

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The Phase I study outcomes from Australia, reported in late 2022, were ‘favourable’, leading to the initiation of the Phase IIa human challenge study last month after the authorisation receipt from the Medicines and Healthcare Products Regulatory Agency (MHRA).

As per the in vitro study findings disclosed by the company last June, the therapy inhibited the activity of the PB2 protein in a newly detected highly pathogenic avian influenza A (H5N1) strain in humans.

Cocrystal’s platform technology allows for detailed three-dimensional structures of inhibitor complexes, which provides immediate insights for ‘Structure Activity Relationships’ and facilitates the quick turnaround of structural information.

In May 2023, the Australian Human Research Ethics Committee (HREC) granted approval to the company to commence the Phase I trial of CDI-988 for Covid-19 treatment.