Biotech Values

[DewDiligence]

ITMN – That’s a very interesting trial design. Although the clinicaltrials.gov entry shows six arms, there are effectively eight arms 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. ITMN-191 900mg BID + SoC; 24 or 48 weeks depending on RVR/EVR;

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

Part 2:

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

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

7. ITMN-191 900mg BID + SoC; 24 weeks unconditionally;

8. SoC alone; 24 weeks unconditionally.


Arm #5 and, especially, arm #8 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.