Dear IPA Board of Directors,
As I’m sure you are aware, the World Health Organization (WHO) has declared a pandemic in response to the COVID-19 (SARS-CoV-2) outbreak. Given this serious health situation, the US Centers for Disease Control and Prevention (CDC) guidelines consider individuals with certain serious chronic medical conditions an especially at-risk population for more severe cases of COVID-19 (SARS-CoV-2).
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 has decided to voluntarily suspend enrollment into SPK-GAA-100 (seroprevalence study) and RESOLUTE (SPK-GAA-101, the Phase I/II gene transfer study) at this time. This voluntary suspension is solely related to the COVID-19 (SARS-CoV-2) pandemic and by suspending enrollment we aim to minimize risk of exposure to COVID-19 (SARS-CoV-2) for participants who would have been traveling to and from investigational sites.
Please note that the recommendation to suspend enrollment in RESOLUTE (SPK-3006-101) is only currently applicable to investigative sites in the US, as EU sites are not yet open to enrolling. Pre-screening activities that can be handled via email or phone may continue, and remote work to ensure that sites in both the US and Europe are positioned to enroll as soon as possible is continuing. As the situation with COVID-19 (SARS-CoV-2) evolves, we will be in close communication regarding this voluntary suspension, especially when we have plans to resume enrollment.
As a leader in the field of gene therapy, we have always placed patient safety first and foremost in our research. During this unprecedented time, we feel this is the responsible way to safeguard the well-being of individuals with Pompe disease and their caregivers who were planning to join our Pompe clinical research programs. Spark Therapeutics remains committed to investigating a potential gene therapy for Pompe disease and restarting the SPK-GAA-100 study and RESOLUTE (SPK-GAA-101) as soon as safely possible for participants.
Please let me know if you have any questions. I am happy to set up a call at your convenience if you would like to discuss further. Thank you for your continued collaboration on our shared goal of supporting the Pompe community.
Amy K. Fisher, MS, CGC
Patient Advocacy Lead