Achillion Pharmaceuticals, Inc.
) recently received a setback when the US Food and Drug
Administration (FDA) placed a clinical hold on its hepatitis C
viral infection (HCV) candidate, sovaprevir after observing
elevations in ALT liver enzymes in a phase 1 healthy subject
drug-drug interaction study.
The phase I study was being conducted to evaluate the effects
of concomitant administration of sovaprevir with Norvir
(ritonavir) boosted Reyataz (atazanavir).
Consequently, Achillion voluntarily stopped further dosing in
the above mentioned study and notified the FDA about its
Meanwhile, enrolment in a phase II study being conducted with
sovaprevir continues. This study is evaluating 12-weeks of
sovaprevir plus ACH-3102 and ribavirin in treatment-naive
patients with genotype 1 HCV.
Since elevated levels of ALT liver enzymes were not observed
in the phase II study of ACH-3102, the FDA has allowed continued
enrollment and treatment of patients in this trial.
Achillion plans to release interim results on the phase II
trial of ACH-3102, including rapid virologic response (RVR)
during the third quarter and sustained viral response (SVR)
during the fourth quarter.
The FDA has asked Achillion to submit reports from two
drug-drug interaction studies along with an integrated safety
analysis of on-going sovaprevir studies. Achillion expects to
submit the FDA with the requested information within six
Shares were down 25.1% on the news.
We note that Achillion has three lead candidates for the
treatment of HCV, namely, sovaprevir and ACH-3102 (both in phase
II), and ACH-2684 (phase I). Sovaprevir and ACH-2684 are NS3
protease inhibitors while ACH-3102 is an NS5A inhibitor. We
expect investor focus on updates on ACH-3102.
We note that
) Incivek and
) Victrelis are approved for the treatment of HCV among others.
Moreover, many large cap companies are developing drugs for the
treatment of HCV.
Achillion carries a Zacks Rank #2 (Buy). Right now,
Aeterna Zentaris Inc
) looks attractive with a Zacks Rank #1 (Strong Buy).
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