CINCINNATI, Ohio — Akebia Therapeutics on Tuesday said it started its first Phase I human study (pdf) of a pill meant to help create new red blood cells in anemia patients.
The drug, AKB-6548, is an alternative to injections of the erythropoietin (EPO) hormone that promotes the growth of red blood cells in bone marrow. Akebia’s drug increases the body’s production of EPO and, if successful through trials, the company thinks it can cut the costs of anemia treatments and expand the treatment to others who can’t take EPO injections for health reasons.
This study will involve 48 healthy volunteers in Cincinnati. The phase 1 study is designed to evaluate the safety and effect of the drug in the body, and will also measure the amount EPO in test subjects. The study should be completed this year.
The eight-member company has recently added two employees and will add two more. It could over the next year or so grow to about 20 depending in part on the clinical data it collects, Chief Executive Officer Joseph Gardner said.
The company is fully funded to complete this Phase I trial and do additional studies. It could in about a year’s time need to raise money to support the testing of its anemia drug and another treatment that prevents vascular leak syndrome, in which blood components leak out of veins and into other system. But the company is also exploring giving licensing rights to a Japanese company to sell the anemia drug in Asia, which would fund continued research for the company, Gardner said.
