Biotech Values

[DewDiligence]

Presidio reports 3-day monotherapy data for PPI-668 (an NS5A inhibitor):

http://finance.yahoo.com/news/presidio-pharmaceuticals-successfully-completes-phase-100000307.html

During the 3-day treatment period, mean maximal HCV RNA reductions for the 4 dosing groups were:

• 3.2 log10 IU/mL in the 40 mg dose group
• 3.5 log10 IU/mL in the 80 mg dose group
• 3.5 log10 IU/mL in the 160 mg dose group
• 3.7 log10 IU/mL in the 240 mg dose group

There was only one minimal-responder in the trial. A patient in the 240 mg dose group was found to be fully resistant at baseline with 100% of this patient’s pre-treatment HCV RNA containing 3 genetically linked NS5A resistance mutations. This patient was excluded from the efficacy analysis of the 240 mg cohort…

…A protocol amendment has been completed to explore the pan-genotypic clinical efficacy of PPI-668 in HCV genotype-2a/3a patients. [I object to the word “pan-genotypic” here, but that’s a nitpick.] Recruitment is currently underway for this added cohort.

Interim data from this trial (in genotype-1 patients) were reported in Apr 2012 (#msg-74622695).