Dive Brief:
- Redx Pharma plc has called a temporary halt on patient accrual to the dose-finding segment of its Phase 1/2a study of RXC004, following clinically significant but unspecified adverse events. These were potentially related to RXC004 on-target effects and Wnt pathway inhibition.
- Systemic exposure to the oral Porcupine inhibitor, which is in development for gastric, biliary and pancreatic cancer, was significantly higher than that predicted from preclinical studies.
- The decision is likely to trigger a delay of several months, and the company's share price dropped to an all-time low of $3.50, before closing over 62% down at $3.87.
Dive Insight:
The first patient in the dose-finding segment of the Phase 1/2a study of the oral Porcupine inhibitor was just dosed in early February at the Christie Hospital in Manchester, U.K. The initial data was expected from this segment in the second half of the year. This timeline may now be in doubt following the pause, as the company consults with the Medicines and Healthcare products Regulatory Agency in the U.K.
"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," said Andrew Saunders, CMO of Redx, in a statement.
Redx has had an eventful six months. Last August it was rescued from administration by Loxo Oncology Inc., which paid out $40 million outright for Redx's Bruton's tyrosine kinase (BTK) program. The financial crisis came as a result of Redx's local council unexpectedly calling in the administrators over a three year £2 million ($2.6 million) loan.
The board believes that the company "has sufficient resources to continue to progress RXC004 and its broader portfolio of oncology and fibrosis assets," and will provide a further update "in due course," according to Iain Ross, Redx's executive chair.
The company has sustained a massive equity value loss over the past six months, dropping from $36 in April 2017 to $3.87 at close of market before the U.K. bank holiday.