In March 2020, after consultation with global investigators, advocacy leadership, and healthcare experts, and in an abundance of caution for the health and safety of people with Pompe disease, Spark Therapeutics decided to voluntarily suspend enrollment into SPK-GAA-100 (seroprevalence study in participants with late-onset Pompe disease (LOPD)) and SPK-GAA-101 (Phase 1/2 gene transfer study, RESOLUTE℠, for LOPD). This voluntary suspension was solely related to the COVID-19 (SARS CoV-2) pandemic and by suspending enrollment we aimed to minimize the risk of exposure to COVID-19 for participants who would have been traveling to and from investigational sites.
After carefully reviewing the emerging data and ongoing measures in place to minimize and prevent the spread of COVID-19 (SARS CoV-2), consulting the recent US FDA-issued guidance for clinical trial conduct during the COVID-19 public health emergency, and discussing with clinicians and scientists with extensive Pompe disease and immunology experience, Spark Therapeutics has restarted enrollment into both studies mentioned above in August 2020.
Spark has thoroughly reviewed and is continuing to evaluate additional aspects of the protocols and study conduct that may also be impacted by COVID-19. The schedule of assessments currently included in the study protocols have been carefully evaluated to minimize visits to study sites. Clinical site personnel are being instructed to conduct any and all COVID-19 related screening procedures that may be mandated by the health care system in which a clinical trial is being conducted. Additional safety measures may be initiated, as per the judgment of the Investigator, per institutional guidelines and in consultation with the Sponsor Medical Monitor.
As a leader in the field of gene therapy, Spark Therapeutics has always placed patient safety first and foremost in our research and remains committed to the investigation of a potential gene therapy for Pompe disease and to safely restarting the seroprevalence study and RESOLUTE℠.
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