
The study achieved its primary objective, indicating that vadadustat maintained stable hemoglobin levels throughout the 16-week treatment period following conversion from recombinant erythropoiesis-stimulating agent (rESA) therapy. Vadadustat demonstrated a favorable safety profile with no drug-related serious adverse events and no deaths.
For some background, Akebia is a biopharmaceutical company focused on delivering innovative therapies to patients with kidney disease through the biology of hypoxia inducible factor.
Akebia Chief Medical Officer Brad Maroni, M.D. commented on the study:
This study was a clear success, demonstrating the potential of vadadustat to effectively and safely treat anemia in dialysis patients switching from injectable rESA therapy. We are impressed with the consistency in hemoglobin levels across the duration of the study, which highlights the ability of vadadustat to control and maintain hemoglobin levels in this patient population. Furthermore, the results indicate that daily and three times per week dosing regimens are both viable options for patients on dialysis.
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John P. Butler, president and CEO of Akebia, said:
These results further confirm vadadustat as a potential best-in-class anemia treatment for CKD patients, and reinforce our confidence in this product candidate as we advance toward our Phase 3 program. Adding these results to the 12 other clinical studies we have completed, we are confident in the potential for vadadustat to treat anemia in a broad array of patients with CKD. We are pleased to have successfully completed this stage of our drug development and look forward to initiating Phase 3 studies.
Shares of Akebia were up 53.3% at $11.97 on Wednesday. The stock has a consensus analyst price target of $18.17 and a 52-week trading range of $5.91 to $23.41.
Despite the overwhelmingly positive performance in the market on Wednesday, and compared to Tuesday’s close, shares are down 65% in the past 52-weeks and down 33% year to date. These gains will wipe out the loss in 2015, but the stock will need to keep this momentum up to get back to its 52-week highs.