Policy & Regulation
Ascelia Pharma's SPARKLE study timelines affected due to COVID-19 pandemic
21 May 2020 -

Ascelia Pharma AB (STO:ACE), an oncology-dedicated orphan drug development company, announced on Wednesday the updated timelines for the completion and top line results of the pivotal phase 3 study SPARKLE with the lead compound Mangoral, which are now expected in H2 2021, instead of the prior communicated H1 2021.

Reportedly, this addition of three to six months to the study reflects the impact of the COVID-19 pandemic.

According to Ascelia Pharma, it is making good progress towards making Mangoral available to physicians and patients as a safe and effective imaging drug used in liver MRI for patients with severe kidney insufficiency or acute kidney injury. However, the COVID-19 pandemic is impacting the pace of the patient inclusion-rate in the SPARKLE study.

Also, related to the COVID-19 pandemic, one of the clinical research organisations (CRO) contracted for the study is experiencing liquidity challenges, and Ascelia Pharma is currently working to find a constructive and sustainable solution to mitigate any possible negative impact on the SPARKLE study.

In light of these consequences of the COVID-19, the timeline of SPARKLE is estimated to be delayed by three to six months.