Replies to post #163352 on Biotech Values

[oc631]

Manifestation of liver toxicity is always a bad thing for a drug that treats liver disease, but in this case it’s even worse than usual. That’s because ACHN was hoping to position ACH-1625 as a best-in-class PI for patents with HCV/HIV co-infection.

I'm unable to pull up a CC replay just yet. The last thing ACHN wants is the FDA looking closer at sovaprevir data. This drug has a questionable safety profile, people are leaving the company, they are raising money when they don't have to, they are running unusually small combo studies, etc. For me the writing's on the wall. The glass half full crowd will buy the dip on news that the combo study is still going and wind up with an empty glass.

[oc631]

Moreover, ACHN does not understand exactly what caused the extremely large (50-350x) increases in the plasma concentration of Sovaprevir observed in the DDI patients who had elevated liver enzymes.

So many HCV patients are co-infected with HIV that sovaprevir stands little chance of advancing into phase 3 combo testing. There's also a chance high plasma exposure was caused by an adverse DDI with the boosting agent ritonavir. That's an even more unwelcome outcome. The FDA won't allow sovaprevir to advance beyond phase-2 IMO until the drug is tested with ritonavir and other classes of HCV DAA's. Specifically sofosbuvir which may be approved by the end of this year. What must be disheartening to ACHN is the grade 3/4 AE's were seen using the 300mg. dose. The 007 combo study is using 400mg. and it's doubtful we will see competitive SVR rates in the combo. Two hundred mg. of sovaprevir would be nearly worthless.

Although the FDA is permitting ACHN to continue enrolling patients in the Sovaprevir + ACH-3102 combination study, the partial clinical hold is nevertheless a big setback, IMO, for the reasons cited above.

Two more patients left to enroll in the 400mg. cohort which has only dosed for 3 weeks at this point in time.