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.
argenx advances ARGX-119 to registrational study for congenital myasthenic syndromes
hVIVO supports Cidara Therapeutics' positive Phase 2b influenza study results
Sanofi's riliprubart receives orphan drug designation in Japan for CIDP
HUTCHMED gains China approval for ORPATHYS and TAGRISSO combination in lung cancer
Hikma Pharmaceuticals USA announces USD1bn of new US investment
UCB reports positive Phase 3 results for fenfluramine in CDKL5 deficiency disorder