Germany-based Atriva Therapeutics is set to conduct a Phase II clinical trial of its oral small molecule, ATR-002, for the treatment of moderate to severe Covid-19 patients requiring hospitalisation.

The multi-national, double-blind, randomised trial is scheduled to launch in July. It will compare ATR-002’s efficacy to that of placebo in hospitalised patients.

In preclinical studies, ATR-002 was found to inhibit viral propagation of SARS-CoV-2, along with an immunomodulatory effect that reduced cytokine and chemokine release.

This dual mechanism of action with antiviral activity and immunomodulation is expected to make the drug a promising therapeutic candidate.

Preclinical studies were conducted at Tübingen and Münster universities using virus strains from recent outbreaks in Germany.

Atriva Therapeutics co-founder and CEO Dr Rainer Lichtenberger said: “ATR-002 could be a game changer in the current pandemic as we see high potential for a patient-friendly oral medication that fundamentally impacts Covid-19 outcomes.

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“To develop ATR-002 for Covid-19 is therefore a logical step in these times and possibly vital for national health systems, patients and families.”

ATR-002 is designed for the treatment of respiratory viral infections via the inhibition of MEK, a host cell factor involved in the replication of different RNA viruses, such as influenza and SARS-CoV-2.

The drug candidate completed a Phase I clinical trial last year. Data showed a promising safety and tolerability profile in healthy volunteers.

Atriva Therapeutics chief medical officer Dr Martin Bauer said: “From the earliest stages of development, it has been our ambition to provide a powerful antiviral to treat influenza and other severe respiratory viral infections.

“At this point, finding an effective therapy to treat moderate to severe cases of Covid-19 is essential for national healthcare systems as we anticipate pandemic infections to remain on the public health agenda.”

As part of a long-term alliance with Atriva, German-based specialty chemicals firm Evonik Industries acts as the development and manufacturing partner for producing  ATR-002 for the Phase II trial.