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Message: Re: BOM 2 Trial

Jun 10, 2020 11:30AM
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Jun 10, 2020 11:38AM

"since it is a BoM2 trial rather than a bolt-on, assuming endpoints would be refocused to BoM1 positive results (with the high p values)??"

The BoM2 comment was interesting - suppose it could be a bolt-on but it makes more sense to have a new trial now that a very specific responder group has been identified (CKD, especially those on SGLT2 inhibitors).  Unfortunately, since an improvement in eGFR seems absent (or too small to be counted on as a primary endpoint), the endpoints will presumably have to be MACE again rather than biomarkers that might respond more quickly.  On the biomarker front, the reduction in ALP might do because high ALP is a known risk factor for all-cause mortality.  Still, MACE including HF seems to be on the table for testing... I guess that we can still hold out hope that it would be a Phase IV trial given the safety record of apabetalone and its apparently high efficacy in this subset of patients.

Jupe

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