How Does Voclosporin Work?
Single Ascending Dose Study Summary
| Trial Design: | The SAD trial was conducted in 46 healthy volunteers to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of trans-voclosporin in healthy volunteers. |
| Dosing Groups: | Dose group 1 - 0.25 mg/kd **Prior to commencing the next escalating dose, the results from the previous dose group were reviewed by the Sponsor (Isotechnika) and the Principal Investigator. |
| Conclusion: | The trial showed that the therapeutic window with the trans-voclosporin formulation appears to be wider than that previously observed with the original formulation. All safety endpoints of the study were achieved. |
The data confirms that the trans formulation of voclosporin (trans-voclosporin) is approximately 1.5 times more potent than the original mixture and up to 5 times more potent than cyclosporine.
The data also suggests that an even stronger correlation exists between blood drug concentration and the observed immunosuppressive effect, confirming the reduction in inter-patient and intra-patient variability with trans-voclosporin. Hence, therapeutic drug monitoring (TDM) of voclosporin will allow for optimization of clinical response while minimizing the potential for adverse events.