COVID-19 causes Moderna to pause a clutch of clinical trials

Stephane Bancel
Moderna CEO Stéphane Bancel (Moderna)

Moderna has become the latest company to hit pause on clinical trials in response to the COVID-19 pandemic. The biotech, which is leading efforts to develop a COVID-19 vaccine, is pausing enrollment in some infectious and rare disease trials while continuing to try to add patients to its cancer studies.

Before it became the poster child for biotech’s fightback against COVID-19, Moderna was focused on a clutch of clinical trials designed to assess the application of its mRNA platform to a range of rare diseases, infectious diseases and cancers. As is happening across the drug development industry, the pandemic and efforts to contain it are negatively impacting Moderna’s studies outside of COVID-19.

Moderna has stopped enrolling new patients in two phase 1 trials that were testing mRNA-3704 and mRNA-3927 in, respectively, methylmalonic acidemia and propionic acidemia. The biotech is yet to dose a patient in either trial. Moderna also hit pause on an age de-escalation trial of its pediatric respiratory vaccine mRNA-1653. 

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In explaining the decision, Moderna pointed to “the special concerns for the safety and health of pediatric patients and their caregivers, and the risks of disruption to the integrity of trials from COVID-19.”

The site enrolling patients in a trial of Moderna’s chikungunya virus antibody mRNA-1944 has also stopped taking on new subjects, and even studies that are fully enrolled may face disruption. Prior to the COVID-19 disruption, Moderna completed enrollment in its cytomegalovirus and Zika trials. Yet, with some participants yet to receive all scheduled doses of the vaccines, Moderna warned that it may be impossible to administer the shots on time, if at all.

That raises the risk that the trials and their findings may be compromised. Moderna is evaluating the impact of the disruption on the integrity of the clinical trials.

Elsewhere, Moderna is trying to push programs forward but is butting up against the difficulties of studying drugs during a pandemic. The biotech’s cancer trials are still enrolling patients, and Moderna is evaluating the initiation of new sites. However, Moderna said “COVID-19 related challenges are leading to delays in enrollment.” 

Moderna’s history of big deals and financing rounds means it is better placed than many biotechs to ride out delays caused by the pandemic. The biotech ended February with access to close to $2 billion in capital. With COVID-19 lowering spending in some areas and Moderna seeking funding for its pandemic vaccine, the biotech thinks it has “several years of cash to fund the business.”

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