Sanofi’s progress in research and development (R&D) has been adversely impacted by the COVID-19 pandemic. As of late August, six of Sanofi’s clinical trials, which were being conducted in 31 countries, have been disrupted, with most of the disruptions being in Phase II and III – including two pivotal trials. These delays will impact regulatory decisions for Sanofi, says GlobalData.

According to GlobalData’s clinical trials database, six trials have been disrupted due to trial delay or slower enrollment issues, and two Phase III pivotal trials testing sarilumab (SAPHYR, TAPERR) for non-COVID-19 indications have been suspended. Out of the six clinical trials disrupted by the COVID-19 pandemic, one is terminated, three are suspended, one trial stopped enrollment, and one is still planned.

Johanna Swanson, Product Manager at GlobalData, comments, “Both of Sanofi’s COVID-19 vaccine candidates are lagging in development when compared to others such as Moderna and Pfizer/BioNTech. However, Sanofi is expecting approvals for its recombinant vaccine in H1 2021 and for its mRNA vaccine in H2 2021.”

Sanofi’s sarilumab is in Phase III development for the treatment of cytokine release syndrome in severe COVID-19 patients. Sanofi/Regeneron is still testing sarilumab in four clinical trials worldwide for COVID-19 treatment, two of which are currently enrolling patients. Sanofi has continued to trial sarilumab despite the discontinuation of the low-dose/severe group and it failing to meet primary and secondary endpoints in ‘critical illness’ patients who require mechanical ventilation.

Swanson concludes, “Sarilumab may also face issues as it is likely to be more expensive than traditional antivirals and could become obsolete as more (more cost-effective) vaccines become available. Sarilumab has projected peak global sales of $856m in 2026, mostly from the US. It is still possible, though unlikely, that sarilumab may be approved for COVID-19 by the end of 2020.”