Ascelia Pharma AB (publ) (ticker: ACE) today announced that the last patient visit has been completed in the clinical study to evaluate the effect of liver impairment on the safety, pharmacokinetics and pharmacodynamics of the company’s lead drug candidate Orviglance. Preliminary results show that Orviglance was well tolerated in patients with liver impairment. The study is part of the ongoing pivotal clinical program for Orviglance and will be included in the marketing authorization package to the regulatory authorities, including FDA and EMA.
Orviglance is Ascelia Pharma’s oral investigational MRI imaging agent used in the visualization of cancer in the liver and is currently in Phase 3 development. The Hepatic Impairment Study evaluates if patients with different degrees of hepatic impairment can tolerate Orviglance since Orviglance is selectively taken up and excreted by the liver.
The study was performed at the Texas Liver Institute in the US in patients with mild, moderate and severe hepatic impairment, respectively. Each severity group had 6 volunteers which was matched to a control group with normal hepatic function. Preliminary data indicate that Orviglance was well tolerated with no serious adverse events. Final results of the Hepatic Study are expected in mid-2022.
“We are pleased to have completed the patient enrollment and it is encouraging to see preliminary results that Orviglance has been well tolerated by patients with different degrees of hepatic impairment. These data are solid step ahead in our preparations for regulatory submission and approval of Orviglance”, said Carl Bjartmar, Chief Medical Officer of Ascelia Pharma.