Redx Pharma Plc (LON:REDX) said it was temporarily halting the early-stage clinical trial of a cancer drug candidate in order to amend the dose-escalation process to start at a lower initial threshold.
The delay to the phase I/IIa study of its Porcupine inhibitor, RXC004, is expected to be “several months” as it consults with regulators at the Medicines and Healthcare Products Regulatory Agency (MHRA) as to the next steps.
"It is our current intention to propose a protocol amendment that enables dose-escalation to re-start at significantly lower dose levels,” said chief medical officer, Dr Andrew Saunders.
“This protocol amendment will be finalised with consultation with both the MHRA and principal investigators."
On dosing of the first patient in the trial, Redx said it encountered what it described as “clinically significant adverse events”.
The drug developer and its academic colleagues said this was 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,” it added.
Chairman Iain Ross said the Redx team continued to believe RXC004 had potential.
“However, in drug development, safety of patients is the first priority and it is appropriate that the board and management has taken the decision to suspend recruitment of further patients to the trial until the company has consulted with the MHRA and agreed a plan to move forward.
“While we remain confident that we can address this issue, we currently estimate that that this suspension will lead to a delay of several months.
“The board continues to believe it has sufficient resources to continue to progress RXC004 and its broader portfolio of oncology and fibrosis assets. We intend to provide a further update in due course.”