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BMS halts hep C candidate development after patient death

Promises to share drug data to assist other pharma companies’ patient safety measures

Bristol-Myers Squibb has called time on its once-promising hepatitis C candidate after a patient developed heart failure and later died in a mid-stage clinical trial.

The drug, BMS-986094, which was being tested in a phase II study with BMS' NS5a inhibitor daclatasvir, and was one of the key assets behind the company's $2.5bn acquisition of Inhibitex earlier this year.

But after voluntarily suspending the trial earlier this month, following which the FDA placed the compound on 'clinical hold', the company has now confirmed that it will discontinue the development of BMS-986094 altogether. 

BMS also said it would share data on the drug with other companies developing similar hepatitis C drugs so that it might inform their own patient safety measures.

BMS said the decision to halt development of BMS-986094 was made in the interest of patient safety, “based on a rapid, thorough and ongoing assessment of patients” in the study.

To date, nine patients in the trial have been hospitalised, including the initial patient, and two patients remain in hospital. The cause of this involves heart and kidney toxicity, but exact details have not yet been definitely established, BMS said.

Chief scientific officer Elliott Sigal said: “The decision to halt development of BMS-986094 has been guided by our overriding interest in protecting patients.

“In the interest of all patients participating in hepatitis C clinical studies, and in cooperation with the FDA, we will make relevant information on BMS-986094 available to inform the development of other investigational compounds to treat hepatitis C. We will also work expeditiously to share the results of our further investigations more broadly in the medical and scientific community.”

The company said it would continue to investigate the safety issue, running studies to evaluate the potential mechanism of this toxicity, and will also closely monitor and follow-up patients who received BMS-986094 across all studies.

The announcement - so early after the Inhibitex acquisition closed - is a major blow to BMS as the firm races with a number of other pharma companies to develop an all-oral treatment regimen that could replace current HCV therapies based on injectable interferon alpha.

The company is exploring other drugs in combination with the NS5a inhibitor daclatasvir in HCV, including Tibotec's NS3 protease inhibitor TMC435, but the regimen with BMS-986094 was considered a cornerstone of its HCV treatment strategy, according to analysts.

24th August 2012

From: Research

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