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Akebia down as vadadustat misses safety endpoints in late studies in CKD anemia

September 3, 2020

Following up on its announcement of positive data in May, Akebia Therapeutics (NASDAQ:AKBA) announces mixed final results from two open-label Phase 3 clinical trials, PRO2TECT-CONVERSION and PRO2TECT-CORRECTION, evaluating vadadustat in adult chronic kidney disease patients with anemia not on dialysis.

Both studies met the primary and key secondary efficacy endpoints demonstrating non-inferiority (NI) to darbepoetin alfa [Amgen’s (NASDAQ:AMGN) Aranesp] but they missed the primary safety endpoint of non-inferiority for major adverse cardiovascular events (MACE) (all-cause mortality, non-fatal myocardial infarction, non-fatal stroke). Specifically, the upper bound of the 95% confidence interval was above the prespecified NI margin of 1.25 (hazard ratio = 1.17, 95% CI: 1.01, 1.36).

The incidence of treatment-emergent adverse events (TEAEs) in CORRECTION was 90.9% compared to 91.6% in patients receiving darbepoetin alfa. The most common were: end-stage renal disease (34.7%/ 35.2%), hypertension (17.7%/ 22.1.%), hyperkalemia (12.3.%/ 15.6%), urinary tract infection (12.9%/ 12.0%), diarrhea (13.9%/ 10.0%), peripheral oedema (12.5%/ 10.5%), fall (9.6%/ 10%) and nausea (10%/ 8.2%). The rates of serious TEAEs were 65.3% and 64.5%, respectively.

In CONVERSION, the rates of TEAEs were 89.1% and 87.7%, respectively. The most common were: end-stage renal disease (27.5%/ 28.4%), hypertension (14.4%/ 14.8%), urinary tract infection (12.2%/ 14.5%), diarrhea (13.8.%/ 8.8.%), peripheral oedema (9.9%/ 10.1%) and pneumonia (10.0%/ 9.7%). The rates of serious TEAEs were 58.5% and 56.6%, respectively.

The company plans to present the full dataset from both INNO2VATE and PRO2TECT programs at an upcoming medical conference and submit for publication.

Confident with the totality of the data, it expects to file a U.S. marketing application as early as possible in 2021. It is working with collaboration partner Otsuka Pharmaceutical Co., Ltd. (OTCPK:OTSKF) on an application in Europe.

Management will host a conference call this morning at 8:30 am ET to discuss the results.

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