The microcap biotech Redx has lurched from a financial pickle straight into a damaging safety issue with its lead drug.
The UK biotech has suspended a Phase I/II trial after the first patient dosed experienced serious adverse events that were “possibly related to RXC004 on-target effects and Wnt pathway inhibition. Importantly, analysis of data from this first patient indicates that their systemic RXC004 exposure was significantly higher than that predicted from preclinical studies.”
Redx shares $REDX were blasted by the news, dropping more than 60%.
A safety crisis and backlash on the stock are about the last thing that Redx needs right now. A year ago Redx shares were suspended after the city of Liverpool said the biotech was delinquent on a £2 million loan.
Redx CMO Andrew Saunders noted:
It is our current intention to propose a protocol amendment that enables dose-escalation to re-start at significantly lower dose levels. This protocol amendment will be finalized with consultation with both the MHRA and principal investigators.
Executive Chairman Iain Ross added that he expects they would be able to get the situation sorted out after a “delay of several months.”
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