Ascelia Pharma is making steady progress in the ongoing pivotal Phase 3 SPARKLE study with its lead compound Orviglance (former working name Mangoral). Nevertheless, the Covid-19 pandemic continues to substantially impact healthcare systems globally, including the conduct of clinical trials. Especially in the U.S., an important country in the SPARKLE study, the increasing infection rates are impacting clinical study activities. In this context, the company expects that the recruitment timeline could be extended up to 6 months into H1 2022 (previously H2-2021).
“Covid-19 has continued to be a challenge for clinical research globally since the outbreak early 2020. Some patients cannot or are unwilling to visit hospitals for clinical tests. Our SPARKLE study is no exception. We have adapted our operational procedures including adding more study sites and made good progress despite the pandemic. However, the continued high infection rates in countries where SPARKLE is ongoing are negatively impacting study sites’ ability and recruitment pace to conduct clinical research and patient enrollment as planned. Our team, together with our study sites, continue to assess and implement possible mitigations to accelerate patient recruitment”, said Carl Bjartmar, Chief Medical Officer at Ascelia Pharma.
“The medical need for a safe and effective liver specific contrast agent is strong and the value that Orviglance can provide to patients and the healthcare system is significant. We are committed to bringing Orviglance to the patients in need and we have a strong cash position well into 2023 providing a solid foundation”, said Magnus Corfitzen, CEO of Ascelia Pharma.
Following the completion of the SPARKLE study, Ascelia Pharma plans to submit a New Drug Application to the FDA with a subsequent launch expected in H2 2023.