Biotech Values

[semi_infinite]

MYOK - re the patient that dropped out because of AF recurrence. Looking at protocol and slide 6 (linked), his beta blocker was stopped 14 days prior to screening. That would be plenty of time for BB to washout as half life is only several hours. AF recurrence started after dosing with 461 and he decided to stop 461 and drop out after failed cardioversion followed by chemical conversion (most prob amiodarone). BB main purpose is to block AF from causing VT so it probably doesn't impact whether AF occurs or not. Since he was paroxysmal already, it could just be bad luck that it occurred right after he started 461, or not. Given exclusion criteria of NOT having any documented AF episodes 12 months prior, it would be easy enough to compare in a blinded study to expected rate of initiation/recurrence (2%/person-year for HCM patients) if N is powered enough.

Many people with AF don't feel it so that would complicate the screening and process for P3 if they don't limit that criteria to "symptomatic" AF.

http://www.myokardia.com/docs/3-01-HFSA-2017-Phase-2-PIONEER-A-Data-Sep2017.pdf