InterMune JP Morgan Notes 1/15/09
Pirfenidone
. Sticking with Jan/Feb (within 6 weeks) timeline. Didn't tip his hand on Pirfenidone at ALL!!
. 97% Transplant Free/Surviving patients had 72 week visit.
. Efficacy analysis will only be performed on high group (CAPACITY 2 has a 2:2:1 randomization the 1 being 1200mg dose)
. Secondary analysis will pool data from both studies (I presume this is high dose only).
. Secondary/Exploratory Endpoints: PFS, Worsening IPF (not defined), Change in percent predicted FVC, Overall Survival, Time to respiratory related hospitalization, Change in extent of fibrosis (HRCT), 6 MWT, Patient report dyspenia & QOL
. Study 75%/25% US/x-US (not sure if this is patients/sites or both), x-US predominately Western Europe
. "Strong and persistent interest" by many Pharma, Biotech and Specialty companies in the drug/company. If CAPACITY positive will engage in discussions to see level of interest.
. If successful strategic decision will be made to: (M&A, Partner x-US, develop internal capability to commercialize in US & EU)
ITMN-191/R7227
. dosing 2nd cohort in INFORM-1
. safety and viral kinetics goal of INFORM-1
. INFORM-2 date TBD q12 dosing
. no change in timeline to report INFORM-1 Q2 major medical meeting (presuming abstract accepted)
1B Triple Combo
. no rebound of any patient in any cohort (q12 or q8)
. Emphasized that in the 13 days after initial first day deep drop consistent drop in viral load over the period.
. patients followed for 30 days after end of treatment. AEs mild to moderate (no rash), consistent with SOC no discontinuations. 4 Grade 3 AE's (2 not 191 related). 2 that were occurred in similar patterns in 191 and placebo groups.
. Commented on usefulness of BLD (Below Level of Detection). Study in 2007 AASLD showing in 28 day treatments no additive predictive value for EVR or SVR of BLD whether below 10, 30 or 50. Think BLQ for 14 day study most relevant metric (study coordinator comment).
Phase 2
. Q2 '09 Start
. 12 and 24 week q8 and q12 doses
. dose TBD
