Excellent help, agmcsf. Thanks.
I hadn't seen that mavrilimumab (a lot of these -mab names are awful-sounding, but this has to be the worst)...maybe because I had been thinking they were a little slow to the game? Slow to start, but they are careening along at a hellish pace now, with 5(!) new trials listed at clinicaltrials.gov, mostly beginning in July and August.
Their EINDs look fabulous too, just like lenzilumab, and with a similar MOA. This definitely speaks to the science in support of lenzilumab. What's the distinction between their respective actions? Is there anything to commend one over the other?
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And if you (or anyone who knows the politics/economics) have any insights about some other questions this brings up, do chime in! Specically, Lenz has a head start in trials, and the trial seems to be well-designed, but can HGEN keep up with Kiniksa (BTW, where do they get all their money?!)?
Also, I don't know a lot about the bureaucracy. What impact will having such restrictive enrollment criteria (that lenz has in the P3 trial) on approval and/or labeling?
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And thanks for the further hints on the therapeutics antibodies. Do you know anything specific about Kd for lenz? Has there been any PK/PD work with lenz-specific parameters, or would that not be necessary? [Actually, I'd be more convinced by clinical results and blood panels than PK/PD, even though there's always a danger of slipping into "correlation implies causation". Best, of course, would be all three pointing in the same direction.]
And, as you say, they've observed clinical response at low doses in RA. But, still, covid-19 is quite different from RA...do you know any work that's been done on dosing for covid-19?
