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BMS and Vertex partner on oral hepatitis treatment

Will investigate combination of daclatasvir and VX-135

Vertex BMS

Bristol-Myers Squibb (BMS) and Vertex Pharmaceuticals have agreed to launch a clinical trial investigating their respective hepatitis C candidates as a combination treatment.

The non-exclusive agreement will see BMS' daclatasvir combined with Vertex' VX-135 in a phase II trial involving about 20 treatment-naïve people with genotype 1 hepatitis C infection.

This will be followed by a second trial involving about 250 people with genotype 1, 2 or 3 hepatitis C, including those with cirrhosis, if data from the first trial proves promising.

The two drugs work in different ways, and it is thought a combination of the two could provide an all-oral alternative to current standard therapy, which involves injection with interferon alpha.

BMS' daclatasvir is an NS5A replication complex inhibitor that is already under investigation in combination with several other therapies, including Tibotec's NS3 protease inhibitor simeprevir (formerly known as TMC435) and BMS' own NS3 protease inhibitor drug asunaprevir.

However, the company received a major blow last year when safety issues meant it had to pull a phase II trial investigating daclatasvir in combination with BMS-986094 – an NS5B inhibitor acquired as part of BMS' purchase of Inhibitex for $2.5bn just months earlier.

This left BMS with a hole in its pipeline that could now be filled by this new collaboration with Vertex.

VX-135 is a uridine nucleotide analogue that, like BMS-986094, is designed to affect the NS5B polymerase to inhibit the replication the hepatitis C virus.

As with daclatasvir, it is also under investigation for combination use with Tibotec's simeprevir, while there are also ongoing trials investigating VX-135 in combination with GlaxoSmithKline's NS5A inhibitor GSK2336805.

In addition, Vertex is planning to test the use of VX-135 along with Incivek (telaprevir), an NS3 inhibitor co-developed by Vertex and Johnson & Johnson.

Dr Robert Kauffman, senior VP and chief medical officer at Vertex, explained the importance of developing new regimens for hepatitis C that only involve oral medicines.

He said: "With more than 170 million people infected worldwide, there is a critical need for new hepatitis C medicines that can offer people simpler and more tolerable treatment regimens that provide high cure rates."

9th April 2013

From: Research

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