Replies to post #95588 on Biotech Values

[turtlepower]

ACHN - The QD dose seems pretty impressive. The only recent comparable PI QD data I can find is for VX-222 which had a 3.4 log reduction for a 1500mg dose for 3 days. In comparison ach-1625 is a 600 mg dose for 5 days. Obviously its a small study but may attract some attention is my guess.

"Treatment with VX-222 resulted in mean reductions in plasma HCV RNA of greater than 3 log10 across the four VX-222 dose
groups. Additionally, an increasing dose response was observed across the four dose groups, with the results in the 500 mg,
750 mg and 1,500 mg dose groups being very similar. The mean HCV RNA decline achieved after three days of dosing with
250 mg BID, 500 mg BID, and 750 mg BID of VX-222 was 3.1 log10 (range: 2.0 to 4.2), 3.4 log10 (range: 3.2 to 3.6), and 3.2
log10 (range: 2.3 to 3.8), respectively. The mean HCV RNA decline achieved after three days of dosing with 1,500 mg QD of
VX-222 was 3.4 log10 (range: 3.1 to 3.9). In the patients receiving placebo, no notable decline in HCV RNA was observed.
Similar viral declines were observed for patients infected with genotype 1a and 1b."

http://files.shareholder.com/downloads/VRTX/0x0x365624/4005613a-8d1a-4876-843d-91a88520ee71/VRTX_News_2010_4_15_Webcasts.pdf

[DewDiligence]

ACHN: ACH-1625 Phase-1b Results by Cohort

[ACHN should have included this table in today's PR :- )]

 
            Cumulative   No. of    Mean Log VL     Mean Log VL   iHub 
 Cohort     Daily Dose  Patients  Chg*(absolute)  Chg*(pbo adj)  Reference 
 600mg BID    1200mg      6,3         3.94            3.72       #msg-44560695 
 500mg BID    1000mg      6,3         4.25            3.96       #msg-45339022 
 600mg qD      600mg      6,2         3.81            3.57       #msg-50041722  
 200mg BID     400mg      6,3         3.86            3.70       #msg-50041722 
  
 *After five days of dosing.

Conclusion: All of the above doses have sufficient efficacy. 600mg qD (or perhaps an even lower qD dose) will presumably be the dose to be carried forward into phase-2 trials.

[DewDiligence]

Any thoughts on Achillion's HCV data?

All HCV protease inhibitors you will hear about have excellent efficacy at halting viral replication quickly; consequently, what distinguishes one HCV PI from another from a commercial standpoint is safety, tolerability, and ease of co-formulation with other antiviral agents.

The daily dose in milligrams is a pretty good proxy for a PI’s safety, tolerability, and ease of co-formulation. On this score, ACH-1625’s cumulative daily dose of 600mg or less (#msg-50044485) is a big improvement relative to Telaprevir (2250mg) and Boceprevir (2400mg). However, a more pertinent comparison is how ACH-1625’s dosing stacks up against the newer generation of PI’s from such companies as BMY, ABT, GILD, and IDIX, among others.