Biotech Values

[DewDiligence]

Updated List of Arms in ITMN-191 Phase-2b Study

The original trial design contained eight arms (although the clinicaltrials.gov entry showed only six of them); now, after the elimination of the arms with 900mg BID, six arms remain as follows:

Part 1

1. ITMN-191 300mg TID + SoC; 24 or 48 weeks depending on RVR/EVR;

2. ITMN-191 600mg BID + SoC; 24 or 48 weeks depending on RVR/EVR;

3. SoC only; 24 or 48 weeks depending on RVR/EVR.

Part 2

4. ITMN-191 300mg TID + SoC; 24 weeks unconditionally;

5. ITMN-191 600mg BID + SoC; 24 weeks unconditionally;

6. SoC only; 24 weeks unconditionally.


Arm #3 and, especially, arm #6 show a new willingness by the FDA to allow a shorter than 48-week duration of interferon + ribavirin to serve as a control arm, which I interpret as an admission by the FDA that the existing standard of 48 weeks of interferon + ribavirin is severely lacking.