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Idenix Pharma Initiates Phase II Study

Zacks Equity Research

Idenix Pharmaceuticals, Inc. (IDIX) recently announced that it has initiated a phase II study (HELIX-1: n = 90) evaluating the combination of hepatitis C virus (:HCV) infection candidates, samatasvir (IDX719) and simeprevir (TMC435). The study is being conducted in collaboration with Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson (JNJ).

As monotherapy, samatasvir is being developed by Idenix Pharma and simeprevir by Johnson & Johnson in collaboration with Medivir AB.

The 12-week, randomized, double-blind and parallel group HELIX-1 study will evaluate three doses of samatasvir (50, 100, or 150 mg). The study will assess the safety and tolerability of samatasvir in combination with simeprevir and ribavirin, a widely used HCV infection drug in first-line non-cirrhotic, genotype 1b or 4 HCV-infected patients.

We remind investors that Idenix Pharma entered into a non-exclusive collaboration agreement with Johnson & Johnson, in Jan 2013, to develop HCV combination therapies. The collaboration will assess different combinations of samatasvir, simeprevir, and TMC647055 (another Johnson & Johnson’s HCV candidate).

As per the terms of the agreement, Idenix Pharma will conduct the studies, while Johnson & Johnson will supply simeprevir and TMC647055 for the trials free of cost.  Both the companies will not receive any milestone and royalty payments as a part of the agreement.

Idenix Pharma plans to initiate a second phase II trial (HELIX-2) on samatasvir, simeprevir and TMC647055 in the second half of 2013.

A sizeable population suffers from HCV the world over. However, the treated population is much lower. This leaves the field open for new treatments.

Both Idenix Pharma and Johnson & Johnson, currently carry a Zacks Rank #3 (Hold). Right now, companies that look well-positioned include Zacks Ranked #1 (Strong Buy) Jazz Pharmaceuticals (JAZZ) and Salix Pharmaceuticals, Ltd. (SLXP).

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