German biopharmaceutical company HepaRegeniX has begun dosing subjects in a Phase Ib trial of HRX-215 in subjects undergoing partial liver resection due to liver metastases originating from colorectal cancer.
The trial aims to assess the therapy’s efficacy and safety, with an initial data readout expected in the second half of this year.
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The randomised, double-blinded trial will enrol 85 subjects, who will be divided into three cohorts and studied at sites in the US.
The first two cohorts will include an active treatment arm for individuals who need minor and major liver resections respectively, while the third cohort includes active and placebo comparator arms for those who require major liver resection.
HepaRegeniX chief medical officer Linda Greenbaum said: “We aim to address a critical unmet need in patients with advanced liver disease who are often considered inoperable due to the limited regenerative capacity of the remaining liver after partial resection.
“HRX-215 may offer a new therapeutic option by promoting hepatocyte regeneration, thereby increasing the safety and feasibility of liver resections in patients who have insufficient predicted postoperative liver mass and/or reduced liver function associated with fatty liver (steatosis) or liver scarring (fibrosis).”
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By GlobalDataThe trial builds on preclinical and clinical data from last year, which indicated that HRX-215 had the potential to enhance liver regeneration and prevent post-hepatectomy liver failure (PHLF) in animal models.
HRX-215 is an orally available small molecule inhibitor of mitogen-activated protein kinase kinase 4 (MKK4).
The drug has shown an acceptable pharmacokinetics and safety profile in a Phase I study involving healthy subjects.
If approved, it could offer a new therapeutic option for individuals who require extensive liver resections, as these patients are currently considered inoperable.
As well as HRX-215, HepaRegeniX is in the process of developing HRX-233, which is designed to target kinase inhibitor treatment resistance in KRAS-driven tumours.
