Exposure biomarker in clinical Phase II trial?
Q: Could you explain more about the exposure biomarker mentioned in your Press Release on May 27, 2020 on the first patient treated with SCO-101?
A: SCO-101 was previously investigated in 4 different clinical Phase I trials in healthy volunteers. The primary objective in these trials was to analyze safety and phamarkokinetics of SCO-101. These investigations showed that SCO-101 was well tolerated and had very good pharmacokinetics (T1/2 around 15 hours). However, it was also noticed that SCO-101 induced an increase in a blood parameter (unconjugated bilirubin). This effect was fully reversible and quickly dropped back to normal levels after dosing of SCO-101 was stopped. The exposure biomarker in the current SCO-101 Phase II study is unconjugated bilirubin, and the levels changed as it was expected based on the clinical Phase I data. The Phase II study is a combination of chemotherapy (FOLFRI) and SCO-101 and the changes in the exposure biomarker demonstrates that SCO-101 is reaching different parts of the body and is exerting its biological effect here.