Biotech Values

[iwfal]

XOMA -

EYEGUARD-A in patients with active disease is expected to read-out by year end; data from EYEGUARD-C, which is studying the effects of gevokizumab in a maintenance setting, is expected in 1Q14; and, EYEGUARD-B which is enrolling patients with Behçet's is expected to read-out last, in 2Q14. Per discussions with the FDA, the company will likely need to meet the primary endpoint in two of the three trials. The risk is that even though all three trials are in NIU, Eyeguard A and C have a different intent-to-treat population than that actually studied in the Ph2 trial. Of course, the trial for which we have the most data, Eyeguard-B, actually reads out last. However, even though the company is running three separate Ph3 trials, the trials are all in non-infectuous inveitis of which Behçet's uveitis is one of the most severe forms. As an investment, it seems logical that if Gevokizumab works in the most severe form of NIU (Eyeguard B) then it should work in the less severe forms (Eyeguard A,C) of the disease as well.

FWIW I wouldn't rate the chances of success in the same order you do - EYEGUARD B being most likely to succeed because it is Beycets, EYEGUARD A and C being less likely because they are all forms of uveitis.

My reasoning - there is a lot of data to indicate that all the different forms of non-infectious uveitis respond the same to the same treatments. Most particularly this appears to be true with anti-TNF agents for which there is boatload of data (almost all pretty mediocre - but in aggregate moderately compelling). And anti-TNFs are next door neighbors to anti-IL-1s.

As for my ranking - I think that the acute disease trial (A) has the best chance of success because the protocol is easy and well-proven in the ph i's. But the chronic treatments have potential protocol problems with confounding - e.g. doc's tapering systemic steroids to offset the benefit coming from Gev - and the fact that it may just be harder to see benefit is a less acute patient population.

BTW - on the topic of tnf agents and IL-1 agents being 'next door neighbors' it is pretty much universally true that if a tnf agent works then the IL-1 agents will probably show some benefit. Sometimes the same, sometimes less (e.g. RA). But if I had to guess I'd guess that uveitis is a disease where the IL-1's show better benefit than the TNFs. For instance, see the Humira ph i results as posted on clinical trials - a much less stringent definition of response and yet they only got a 2/3 response. And the other clinical data in the TNFs all says about the same - about 50% or a little more. That said, there is still a lot of uncertainty on that kind of comparison across trials. (Another interesting case is the case report of scleritis in RA patients - the TNF agents did not solve it, but anakinra did in a repeatable way)