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Message: Re: Epigenetic Therapeutic Targets Virtual Summit Presentation July 28, 2020

Further on this point about the apabetalone/ACE2/COVID Phase 2 clinical trial referenced in yesterday's presentation.......it is still unclear if they are proposing to test apabetalone as a preventative therapy to reduce ACE2 in order to prevent viral infection and/or viral replication, or alternatively to treat the symptoms of severe viral infection (e.g. inflammation, acute phase response, cardiopulmonary, etc). This is a really important distinction that greatly impact trial design, patient inclusion/exclusion criteria, timing of treatment, trial endpoints, etc.

As I was writing this, I remembered this previous news release:

"An additional step will be to proceed with an open-label study to assess the safety and efficacy of a clinical course of oral apabetalone in hospitalized subjects with 2019-nCoV infection on top of standard of care compared to standard of care alone. Endpoints will include clinical progression, an evaluation of viral levels via nasal and pharyngeal swabs, as well as the effect of apabetalone on key virus-related biomarkers including ACE2 and others within the renin-angiotensin system, as well as an inflammatory panel of markers including IL6, IL8, CRP, etc. in hospitalized subjects with 2019-nCoV infection."

So it sounds like the proposed trial is NOT to prevent viral infection, but instead to lessen the COVID disease buren in already infected and hospitalized patients.

BDAZ

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