Biotech Values

[DewDiligence]

IDIX has finally reached agreement with the FDA on the design of the NM283-ribavirin drug-interaction study. It will contain three arms of 30 patients each: NM283+ifn+riba, NM283+ifn, and ifn+riba. PK/PD will be evaluated at 36 days and safety will be evaluated at the end of dosing at 12 weeks.

This is a welcome piece of news because this trial—a prerequisite for proceeding to phase-3 with NM283—had been held up all summer while IDIX and the FDA worked on the design. The trial will now begin as soon as clearance is obtained from the trial-center IRBs.

(Source: IDIX UBS webcast)