Voclosporin and Psoriasis As I reviewed in a previous post on uveitis - an indication that continues in clinical trial and for reasons discussed in that post - psoriasis remains a viable indication for voclosporin. In fact it is a personal interest in psoriasis that drew my interest in ISA several years ago. in truth I am a very small investor and what little I have invested in ISA has been wiped out - my holdings now might buy me a reliable second hand used Ford. I've taken a small bath financially as have many who post here. But that's the risk we all took. Still, I remain positive on the longer term prospects for this drug because the science is good and the clinical trials have been promising and the drug itself cannot help but make it to the marketplace - there is simply nothing else out there that rivals voclosporin - if the safety issues are fully resolved. Safety here is everything, for uveitis, psoriasis, stents, and of course for transplant. So, what about psoriasis? The 2008 Lancet publication on voclosporin (then still called ISA247) concluded that ISA 247 "was safe and effective in the treatment of patients with moderate to severe psoriasis during 24 weeks, with the highest dose providing the best efficacy. The strong correlation between ISA247 concentrations and efficacy might allow for accurate dosing of patients compared with existing calcineurin inhibitors." Antoninus has asked what heppened to uveitis and psoriasis, etc. The simple answer is that until longer term clinical studies are done none of these indications will hit the market. We simply must do clinical studies. The statement of Limitations on the ISA psorisis study published in J Am Acad Dermatol. 2006 Mar;54(3):472-8. Epub 2006 Jan 23, says it all: "current oral calcineurin inhibitors for the treatment of psoriasis is limited by toxicity." That was good news for ISA in 2006 and it remains good news. BUT, as the study in that same publication states: "Longer-term studies are needed to evaluate the effect of ISA247 on renal function." So, there we have it. Voclosporin will never get market approval until longer term studies are done. Why have they not been done? Well, they are proceeding for uveitis but not psoriasis. Why not? It too expensive and the psoriasis market is too crowded. However, clinical trials will probably be done for transplant - and that is exactly what all the fuss is about right now in Korea with Iljin and in China with 3SBIO and in Switzerland with Vifor Pharma. ISA needs to cobble together a significant phase 3 Clinical trial for transplant to finally settle this issue of safety. Once that is done the largest indication - transplant - get get underway. Then we will be off to the races. After that those other indications would follow. I hear a lot of concerns expressed here about mismanagement and missed opportunity. I'm not convinced that ISA has not followed the prudent path since the Roche deal fell though. Pursuing uveitis and psoriasis and stents, etc., would have been folly after Roche - not because those indications were not promising, but simply because it would have been unwise to spend a king's ransom on clinical trials for a minor indication. The transplant indication is huge. ISA is following that one because it is huge, and they have the transplant field all to themselves. Yes, it's frustrating. Yes, it's disappointing. Yes, it will take much longer than any of us ever wanted. But it's the only sane path that ISA can follow right now and that's where they are headed. Stay tuned.