Idenix Pharmaceuticals ($IDIX) announces initial data from phase I clinical trial of IDX719

Idenix Pharmaceuticals NASDAQ: IDIX) is engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases.

• IDX719 is an an NS5A inhibitor for the treatment of hepatitis C virus (HCV) infection
• In the first part of the study, eight healthy volunteers received 100 mg of IDX719 daily for seven days. All doses were well tolerated and pharmacokinetic data supports once-daily dosing in future studies.
• In the second part of the study, single-ascending doses of IDX719 achieved substantial viral load reductions in the following cohorts of HCV-infected patients:
  • A cohort of 12 HCV genotype 1-infected patients received single IDX719 doses of 1, 5, 10, 25, 50 or 100 mg (2 patients per dose). Mean maximal viral load reductions were 1.9 log10, 2.6 log10, 3.3 log10, 3.7 log10, 2.8 log10 and 3.5 log10, respectively;
  • A cohort of three HCV genotype 2-infected patients received single IDX719 doses of 25, 50 or 100 mg (1 patient per dose). Maximal viral load reductions were 0.4 log10, 3.2 log10 and 3.5 log10, respectively; and
  • A cohort of three HCV genotype 3-infected patients received single IDX719 doses of 25, 50 or 100 mg (1 patient per dose). Maximal viral load reductions were 2.2 log10, 3.7 log10 and 3.3 log10, respectively.
• A three-day proof-of-concept study has initiated dosing and is designed to evaluate 64 treatment-naïve genotype 1, 2, 3 or 4 HCV-infected patients.
• Additionally, Idenix has completed enrollment of the second cohort of 30 patients in the ongoing 12-week phase IIb study of IDX184. IDX184 continues to be safe and well tolerated with no treatment-emergent serious adverse events reported and a side effect profile similar to that of PegIFN/RBV. Further data from the ongoing clinical trial will be available in H2.

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Brean Murray, Carret & Co. on Indenix: "INFORM-SVR Data Has Negative Implications for IDX184 – All-Oral Regimen" ($IDIX)

Idenix Pharmaceuticals, Inc. (IDIX) is engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases. Building on its expertise in nucleoside chemistry and other small molecule chemistry and biology, the company is well positioned to become a leader in antiviral pharmaceuticals. Idenix's current focus is on the treatment of hepatitis C virus (HCV) infections. The company has previously discovered and developed antivirals for the treatment of hepatitis B virus (HBV) and HIV/AIDS.

Brean Murray, Carret & Co. has released a report on Idenix, classifying it as "Sell" with a price target of $3. 

The report states, 

"Roche posted an unacceptable relapse rate for patients taking mericitabine + danoprevir + ritonavir + ribavirin  for 12 weeks. Even at 24 weeks, the SVR rate was only 41%. We view this as a very good surrogate for any oral combination that includes IDX184, as we view the clinical antiviral activity of 100 mg IDX184 and 1000 mg of merictabine as equivalent. We believe Idenix (IDIX, $9.85, Sell) will need to explore regimens with durations of greater than 12 weeks to be effective. Given that the company has yet to initiate preclinical tox work in excess of 12 weeks, we believe this could significantly delay clinical development and makes IDX184 substantially less attractive as a potential backbone therapy."

Read the full report here.