SemBioSys reports positive results from recombinant human insulin study

SemBioSys Genetics, a Canadian biotechnology company, has reported positive preliminary results of its first ‘in-man’ clinical study of SBS-1000, a recombinant human insulin manufactured using its proprietary platform. The trial demonstrated that SBS-1000 was bioequivalent to a recombinant human insulin with the expected safety profile.

In this single administration, double blind trial, 23 healthy volunteers were administered the same dose of SBS-1000, Humulin R (recombinant human insulin marketed in the US by Eli Lilly) and Humulin S (recombinant human insulin marketed in the UK by Eli Lilly) in a three way cross-over study. This euglycemic clamp study coupled insulin administration with glucose infusion to maintain the volunteers’ blood sugars at baseline levels.

In this study, both SBS-1000 and Humulin R were bioequivalent to Humulin S with respect to total insulin exposure, maximum concentration of insulin and total glucose infused.

According to SemBioSys, the only anomalous result from this trial relates to some of the Humulin S data. Neither SBS-1000 nor Humulin R was bioequivalent to Humulin S with respect to the maximum glucose infusion rate. This difference between the two reference standards (Humulin R and Humulin S) was not expected in such a trial and relates, at least in part, to random outliers that occurred in the Humulin S arm and higher overall variability for this endpoint in the trial.

Maurice Moloney, chief scientific officer and founder of SemBioSys, said: This is the first time one of our plant-derived recombinant proteins has been studied in humans and we were gratified to see that SBS-1000 performed in an equivalent manner to marketed recombinant human insulin with respect to pharmacologic activity and tolerability. We would anticipate that full results of this trial will be submitted to a future scientific conference once all data have been analyzed.