1. ACHN is in the process of starting the next 2 cohorts for ACH-1625 in its Phase 1b HCV trial. One cohort will be a BID dose lower than 500mg and the other will be a QD dose higher than 500mg BID (i.e., QD dose will be greater than 1000mg QD). ACHN expects to report results from these two additional cohorts in the middle to second half of April.
2. ACHN accepted for a late breaker presentation at EASL to discuss results from the first two ACH-1625 Phase 1b cohorts. ACHN will also be presenting two additional virology presentations regarding ACH-1625.
3. The partnering of ACH-1625 is discussed beginning just before the 18 minute mark of the presentation. The initial statement is that it's "likely we will partner this compound" without any specific timeframe reference. The president then went on to note, however, that ACHN has recently raised sufficient cash to take the compound through Phase 2 on its own. Given the foregoing, I inferred that ACHN is leaning towards partnering ACH-1625 before commencing the Phase 2 trial on its own in 2H2010. All IMHO. Listen to the call and see if you agree. Hopefully ACHN has a nice offer on the table now without having to proceed to the Phase 2 trial on its own.
4. ACHN still expects to partner ACH-2684 apart from ACH-1625 though it will entertain offers. ACHN said it will likely take ACH-2684 through to PoC stage in order to obtain a better partnering deal.
5. Under the "technical definition," ACH-2684 is protease or protease-like, but it is very different structurally and in terms of its activity compared to other PIs.
6. The FDA has largely agreed with the path forward for ACH-1095 and the trial design and has encouraged ACHN to file the IND for the compound. ACHN expects to file the IND close to the end of the year, although 1095 is 3rd in priority behind 1625 and 2684.
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