Injections of EPO are expensive, with a year’s therapy for a dialysis patient costing up to $10,000. The Centers for Medicare & Medicaid Services is revising its payment schedule for drugs used at dialysis clinics.
“The price pressures on EPO are already intense and will become more so,” points out Dr. Gardner. The company believes its small molecule drug candidates will be more affordable and patient-friendly and safer than injectable EPO.
A few other firms are developing oral small molecule drugs to treat anemia, and these compounds are undergoing early clinical trials. “We all manipulate the same pathway,” says Dr. Gardner, who adds that public data suggests that Akebia’s AKB-6548 offers a better dosing regimen and safety advantages over its potential competitors.
Other compounds in the HIF-PH inhibitor series stimulate the immune system instead of erythropoiesis. Early tests show that some are powerful anti-infectives that kill antibiotic resistant strains of bacteria such as methicillin-resistant Staphylcoccus aureus (MRSA).
“The HIF-PH pathway has powerful and complicated biochemical mechanisms,” notes Dr. Gardner. Collaborations with Randall Johnson, Ph.D., an expert in HIF at the University of California, San Diego, are helping Akebia scientists to select compounds for different disease indications.