EMA working on Ph I concept paper after death in Biotrial BIA 10 2074 study

By Gareth Macdonald contact

- Last updated on GMT


Related tags: Pharmacology, Pre-clinical development

A revised concept paper on first-in-human trials will be ready next month according to the EMA which is reviewing the French Phase I trial in which one volunteer died in January.

The European Medicines Agency (EMA) said it was working on a new Phase I trial best practices paper last week, explaining the aim is to incorporate findings from assessments by the French medicines agency (ANSM) and the inspectorate for social affairs (IGAS).

One man died and five others were hospitalised during the study of BIA 10 2074 in January​. According to IGAS report​ while the ANSM-approved protocol for the study was sound, its implementation by Rennes-based contract research organisation (CRO) Biotrial was flawed.

The inspectorate also criticised Portuguese drug developer Bial for failing to report the death and hospitalizations in a timely manner. Both Bial and Biotrial have denied any wrongdoing.

EMA review

The EMA said: “Severe adverse reactions in healthy volunteers such as those observed in the trial in Rennes are extremely rare during clinical trials. Since 2005, approximately 14,700 phase I clinical trials with participation of 305,000 subjects have been conducted in the EU, including 3,100 first-in-human studies​.”

Only one other severe incident has been previously reported in that time in the EU​.”

The agency added that the goal is to identify “areas for change and proposals to further minimise the risk of similar accidents” ​adding that “the concept paper will form the basis for an EU-wide review of the guidelines​.”

The EMA said it aims to "agree a concept paper by July.​"

Preclinical studies

The EMA also set out the framework for the review, explaining that one team will focus on preclinical assessment of drug candidates with a second separate group concentrating on clinical trial design.

Questions were raised about preclinical trials of BIA 10 2074 after documents leaked to Le Figaro in February (here in French​) revealed several dogs had died during toxicology research.

Bial confirm this, telling us several dogs in preclinical trials of the drug had been put down as a result pulmonary lesions.

Others have also suggested the type and quality of information sought during preclinical development also needs to be reassessed.

In March​, Michael Eddleston, professor of clinical toxicology at the University of Edinburgh, suggested regulators and industry need to rethink preclinical risk assessments in an article in the  British Journal of Clinical Pharmacology.

He told us “Drug pharmacology has to be better described and then studied during the preclinical and clinical studies. This aspect will reduce the risk of similar problems occurring - the starting dose for both TGN1412 and this Bial drug appear to have been far too high​.”

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