Redx Pharma PLC (LON:REDX) announced it is moving to phase 2 of trials for its lead drug candidate RXC004, expected to start during the second half of 2021.
The drug discovery and development company has selected dosage of 2mg once daily, based on the safety profile observed in phase 1.
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The primary objective of the phase 1 study was to establish the safety and tolerability of the cancer drug in patients and preliminary data showed that RXC004 was safe, tolerated and provided target coverage at levels required to assess monotherapy efficacy.
The monotherapy targets the porcupine enzyme, a key one in Wnt-ligand driven cancers, as it drives both tumour growth and immune evasion.
The phase 2 programme will recruit patients with three tumour types – microsatellite stable metastatic colorectal cancer, pancreatic cancer and biliary tract cancer – which all have a high unmet need with limited treatment options and poor five-year survival rates.
Initial results might be available from 2022, the AIM-listed firm said.
“Our phase 1 monotherapy study supports our belief that RXC004 has the potential to be a significant, novel targeted medicine for the treatment of Wnt-ligand driven cancer,” said chief executive Lisa Anson in a release.
“Our distinctive approach to drug discovery has enabled our highly talented scientific team to design our Porcupine Inhibitor to unlock the therapeutic potential of Wnt pathway blockade, a long sought-after oncology target. The decision to progress to phase 2 and the selection of our monotherapy dose represent major milestones in the clinical development of our lead asset."