The current PoC is targeting the 500,000 patients who have inflammatory EOA as evidenced by elevated C reactive protein (CRP). However, only about a quarter of the patients being screened for the Ph2 trial have elevated CRP levels. Consequently, the company announced a second PoC trial for EOA patients who do not meet the "active inflammatory" CRP threshold. According to the company, "This study will tell us if gevokizumab works in the broader EOA population as estimated to be 1.8 to 2.2 than people in the U.S. or they may tell us gevokizumab only works in the patients who are in inflammatory stage of the disease which might approximate about 500,000 patients." The second EOA trial in low CRP patients should provide better insight into the validity/necessity of the CRP biomarker.
It is up on CT now. In a quick glance it looks very similar to the first trial (no reference to CRP in either writeup). The only difference to be found is that the first trial was described as being for "active inflammatory OA" and for the second the adjective "active" was removed.
Note that interestingly at the bottom of the Inclusion/Exclusion criteria for both they note that Other protocol-defined inclusion/exclusion criteria may apply. Clearly CRP is one of those - but it wouldn't surprise me if there were other criteria that defined 'active' - e.g. palpable effusions is the most obvious one and there are hints it is more tractable wrt treatment.
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