Isotechnika Inc announced that its Essence phase-3 trial of voclosporin in moderate to severe psoriasis patients successfully met the primary endpoint of superiority to placebo in the proportion of patients achieving a score of 'clear' or 'almost clear' in the Static Physician's Global Assessment (SPGA) at 12 weeks of treatment. The data will be presented in more detail at the upcoming Canadian Dermatology Association 84th Annual Conference in Vancouver, Canada on July 1 to 5, 2009.
In the voclosporin arm 35 per cent of patients achieved a 'clear' or 'almost clear' SPGA score at 12 weeks compared to 6 per cent of patients receiving placebo (p (less than) 0.001). Another widely used measure of efficacy for psoriasis treatments is the reduction in the Psoriasis Area and Severity Index (PASI). In the voclosporin arm 43 per cent of patients at 12 weeks and 46 per cent of patients at 60 weeks achieved a 75 per cent reduction in PASI (PASI-75) and 67 per cent of patients at 12 weeks and 68 per cent of patients at 60 weeks achieved a 50 per cent reduction in PASI (PASI-50).
In addition to the placebo control, the study also included an active comparator arm, cyclosporine. The secondary endpoint of non-inferiority to cyclosporine, which had a score of 'clear' or 'almost clear' in SPGA in 53 per cent of patients, was not met.
"While we would have liked to have seen 'non-inferiority', we are pleased with the risk-benefit of voclosporin and consider it a valuable treatment option. This is true particularly in light of the reported lower 12 week PASI-75 scores of the market leading treatment, etanercept," explains Dr Foster, president & CEO of Isotechnika.
"The results from the Essence study confirm the safety profile of voclosporin," stated Dr Wayne Gulliver, one of the Canadian Principal Investigators for Essence. "The efficacy seen with voclosporin combined with a reduced number of risk factors for cardiovascular disease fills an unmet need for patients and should be readily adopted."
Voclosporin demonstrated positive outcomes on other pre-specified secondary endpoints at 24 weeks reported in a descriptive manner. In each of these safety parameters, the advantages observed in the voclosporin arm at week 24 versus the cyclosporine arm were maintained through to week 60 of the study. In particular, the cardiorenal risk associated with voclosporin appears to be reduced as the incidence of triglyceride elevation, hypertension and renal adverse effects were all lower than for cyclosporine. In addition, voclosporin showed clear improved safety over cyclosporine with regards to headache, pareasthesia, and hirsutism.
"Essence has confirmed the previous safety and efficacy data from our Canadian phase-3 trial," explains Dr Foster. "We believe that it provides an essential addition to the armamentarium of Dermatologists to treat this debilitating disease. Our objective was to show that voclosporin is of significant value to patients and physicians and provides a serious treatment alternative."
Edmonton-based Isotechnika is a biopharmaceutical company focused on the discovery and development of novel immunosuppressive therapeutics that are designed to offer advantages over other currently available treatments.
Voclosporin is a next generation calcineurin inhibitor, which recently completed a phase-2b North American trial for the prevention of kidney rejection following transplantation.