By writer to baytownsun.com
CAMBRIDGE, Mass., Oct. 23, 2020 /PRNewswire/ — Akebia Therapeutics, Inc. (Nasdaq: AKBA), at this time introduced the presentation of scientific knowledge from its PRO2TECT international Section Three program that evaluated the efficacy and security of vadadustat, Akebia’s investigational oral hypoxia-inducible issue prolyl hydroxylase inhibitor (HIF-PHI), versus darbepoetin alfa for the remedy of anemia as a result of power kidney illness (CKD) in grownup sufferers not on dialysis, at American Society of Nephrology Kidney Week 2020 Reimagined (ASN Kidney Week). As beforehand introduced, vadadustat achieved the first and key secondary efficacy endpoints in every of the 2 research in this system, however didn’t meet the first security endpoint. Newly introduced pre-specified regional analyses of the PRO2TECT program present vadadustat demonstrated no clinically significant enhance in cardiovascular threat in comparison with darbepoetin alfa in analyses of MACE, expanded MACE and all-cause mortality in U.S. sufferers handled to a goal hemoglobin (Hb) vary of 10 to 11 g/dL, per U.S. remedy tips.
“The PRO2TECT outcomes present that orally administered vadadustat achieved each major and secondary efficacy endpoints in sufferers not on dialysis with anemia related to CKD. The newly introduced analyses confirmed that there have been regional variations with respect to MACE, expanded MACE and all-cause mortality, per well-known, differing regional hemoglobin remedy goal tips,” stated Glenn Chertow, M.D., M.P.H., Professor of Medication, Chief, Division of Nephrology at Stanford College, and Co-Chair of the impartial Govt Steering Committee for PRO2TECT and INNO2VATE. “The analyses additionally affirm there was no elevated cardiovascular threat related to vadadustat throughout the U.S. sufferers handled to a goal hemoglobin vary of 10 to 11 g/dL.”
The PRO2TECT knowledge are being introduced at this time throughout a late-breaking oral presentation, titled “World Section Three Medical Trials of Vadadustat vs Darbepoetin Alfa for Therapy of Anemia in Sufferers with Non-Dialysis-Dependent Power Kidney Illness” (Summary FR-OR54) at ASN Kidney Week. Akebia’s vadadustat improvement program additionally contains INNO2VATE, the worldwide Section Three program for the remedy of anemia as a result of CKD in grownup sufferers on dialysis. Outcomes from this program have been introduced at ASN Kidney Week in an oral presentation on October 22, 2020.
Highlights of the PRO2TECT ASN Kidney Week Presentation:
As beforehand reported, vadadustat achieved the first and key secondary efficacy endpoints in every of the 2 PRO2TECT research, which demonstrated non-inferiority of vadadustat to darbepoetin alfa as measured by a imply change in Hb between baseline and the first analysis interval (weeks 24 to 36) and secondary analysis interval (weeks 40 to 52). Non-inferiority was achieved because the decrease certain of the 95% confidence interval for the between-group distinction of the imply Hb change didn’t fall under the pre-specified non-inferiority margin (-0.75 g/dL).
As beforehand reported, vadadustat didn’t meet the first security endpoint of the PRO2TECT program outlined as non-inferiority of vadadustat versus darbepoetin alfa in time to first incidence of main hostile cardiovascular occasions (MACE), which is the composite of all-cause mortality, non-fatal myocardial infarction (MI), or non-fatal stroke throughout each PRO2TECT research.The evaluation of the first security endpoint used a Cox regression mannequin that was pre-specified to be adjusted for sure variables, together with age dichotomized >65 and ≤65 years.With a view to optimize the Cox mannequin used to research the first security endpoint and enhance its statistical energy in regional subsets, age was rescaled from dichotomous to a steady variable.Within the optimized Cox mannequin, the hazard ratios (HR) have been attenuated and the arrogance intervals (CI) have been narrowed.The PRO2TECT research evaluation plan was prospectively designed to research the impact of regional variations, most notably, well-known variations in Hb remedy targets. Inside the research, U.S. sufferers have been handled to a goal Hb vary of 10 to 11 g/dL and non-U.S. sufferers have been handled to a goal Hb vary of 10 to 12 g/dL.In a pre-specified regional evaluation utilizing age as a dichotomous variable, vadadustat was not related to a clinically significant enhance in cardiovascular threat in comparison with darbepoetin alfa in U.S. sufferers handled to a goal Hb vary of 10 to 11 g/dL, with a MACE HR of 1.06 (0.87, 1.29). This was confirmed utilizing age as a steady variable as proven under.The incidence of remedy emergent hostile occasions throughout the ESA-untreated sufferers (Correction) research within the vadadustat-treated sufferers was 90.9%, and 91.6% in darbepoetin alfa-treated sufferers. In the course of the research, the most typical remedy emergent hostile occasions reported in vadadustat/darbepoetin alfa-treated sufferers have been end-stage renal illness (34.7%/ 35.2%), hypertension (17.7%/ 22.1.%), hyperkalemia (12.3.%/ 15.6%), urinary tract an 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%). Severe remedy emergent hostile occasions have been 65.3% for vadadustat-treated sufferers and 64.5% for darbepoetin alfa-treated sufferers. The incidence of remedy emergent hostile occasions throughout the ESA-treated sufferers (Conversion) research in vadadustat handled sufferers was 89.1% and 87.7% in darbepoetin alfa-treated sufferers. In the course of the research, the most typical remedy emergent hostile occasions reported in vadadustat/darbepoetin alfa-treated sufferers have been end-stage renal illness (27.5%/ 28.4%), hypertension (14.4%/ 14.8%), urinary tract an infection (12.2%/ 14.5%), diarrhea (13.8.%/ 8.8.%), peripheral oedema (9.9%/ 10.1%) and pneumonia (10.0%/ 9.7%). Severe remedy emergent hostile occasions have been 58.5% for vadadustat-treated sufferers and 56.6% for darbepoetin alfa-treated sufferers.
“The newly introduced pre-specified analyses of PRO2TECT confirmed that vadadustat had no clinically significant enhance in cardiovascular threat in U.S. sufferers not on dialysis handled to a goal hemoglobin vary of 10 to 11 g/dL, per U.S. remedy tips. Upon submission of our NDA for vadadustat, we count on that the potential approval of vadadustat as a remedy for sufferers not on dialysis will probably be a evaluate concern for the FDA, and we proceed to imagine that these essential analyses, along with the totality of information from our Section Three program, will inform that evaluate,” stated John P. Butler, President and CEO of Akebia Therapeutics. “We stay assured that vadadustat has an easy path to potential approval for the remedy of sufferers on dialysis, globally.”
Akebia plans to undergo the U.S. Meals and Drug Administration (FDA) a New Drug Utility (NDA) for vadadustat for the remedy of anemia as a result of CKD in grownup dialysis-dependent and non-dialysis dependent sufferers as early as potential in 2021. As well as, Akebia and its collaborator, Otsuka Pharmaceutical Co. Ltd., are working collectively to additional analyze these research outcomes to help a Advertising and marketing Authorization Utility (MAA) for submission to the European Medicines Company (EMA) subsequent yr.
Investor Briefing Webcast Akebia administration will host an investor briefing webcast with Dr. Glenn Chertow on October 23, 2020 at 4:10 p.m. ET to evaluate highlights of the worldwide Section Three vadadustat knowledge shows from ASN Kidney Week. To entry Akebia’s investor briefing webcast and the accompanying slides please log into the Traders part of the Firm’s web site at https://ir.akebia.com and proceed to the occasions and shows web page at https://ir.akebia.com/events-and-presentations. Please connect with the Firm’s web site no less than 10 minutes previous to the net occasion to make sure sufficient time for any software program obtain that could be required to view the webcast. After the webcast concludes, a replay of the occasion will probably be accessible at that very same location till October 29, 2020
Concerning the PRO2TECT World Section Three Program of Vadadustat Akebia’s international PRO2TECT program included two separate Section Three research of ESA-untreated sufferers (Correction) and ESA-treated sufferers (Conversion), which collectively enrolled 3,476 grownup sufferers not on dialysis with anemia as a result of CKD. Each PRO2TECT research have been international, multicenter, open label (sponsor blind), active-controlled (darbepoetin alfa – an injectable erythropoiesis stimulating agent (ESA)), non-inferiority research. In each research, sufferers have been randomized 1:1 to obtain both vadadustat or darbepoetin alfa. Efficacy and security outcomes have been measured towards non-inferiority margins agreed upon with the FDA and the EMA.
About Anemia as a result of Power Kidney Illness (CKD) Anemia is a situation through which an individual lacks sufficient wholesome purple blood cells to hold sufficient oxygen to the physique’s tissues. It generally happens in individuals with CKD as a result of their kidneys don’t produce sufficient erythropoietin (EPO), a hormone that helps regulate manufacturing of purple blood cells. Anemia as a result of CKD can have a profound impression on an individual’s high quality of life as it may possibly trigger fatigue, dizziness, shortness of breath and cognitive dysfunction. Left untreated, anemia results in deterioration in well being and is related to elevated morbidity and mortality in individuals with CKD.
About Vadadustat Vadadustat is an oral hypoxia-inducible issue prolyl hydroxylase (HIF-PH) inhibitor designed to imitate the physiologic impact of altitude on oxygen availability. At larger altitudes, the physique responds to decrease oxygen availability with stabilization of hypoxia-inducible issue, which may result in elevated purple blood cell manufacturing and improved oxygen supply to tissues. Vadadustat is in international Section Three improvement for the remedy of anemia as a result of CKD and isn’t permitted by the U.S. Meals and Drug Administration (FDA) or any regulatory authority excluding Japan’s Ministry of Well being, Labour and Welfare (MHLW). In Japan, vadadustat is permitted as a remedy for anemia as a result of CKD in each dialysis-dependent and non-dialysis dependent grownup sufferers.
About Akebia Therapeutics Akebia Therapeutics, Inc. is a totally built-in biopharmaceutical firm with the aim to raised the lives of individuals impacted by kidney illness. The Firm was based in 2007 and is headquartered in Cambridge, Massachusetts. For extra data, please go to our web site at www.akebia.com, which doesn’t type part of this launch.
Ahead Wanting Statements Statements on this press launch relating to Akebia’s technique, plans, prospects, expectations, beliefs, intentions and targets are forward-looking statements inside the that means of the U.S. Non-public Securities Litigation Reform Act of 1995, as amended, together with however not restricted to statements relating to the expectation that the potential approval of vadadustat within the U.S. as a remedy for sufferers not on dialysis will probably be a evaluate concern for the FDA; the assumption that newly introduced analyses of PRO2TECT and the totality of the information from the worldwide Section Three program of vadadustat will inform the FDA’s evaluate of remedy of sufferers not on dialysis with vadadustat; the potential for acquiring approval of vadadustat in dialysis; the potential indications for and advantages of vadadustat; submitting filings for advertising approval of vadadustat, and the timing thereof; and the scientific alternative for vadadustat. The phrases “imagine,” “assured,” “count on,” “plan,” “potential,” “will,” “working” and comparable references are meant to determine forward-looking statements, though not all forward-looking statements comprise these figuring out phrases. Every forward-looking assertion is topic to dangers and uncertainties that would trigger precise outcomes to vary materially from these expressed or implied in such assertion, together with the timing and content material of recommendation given and selections made by well being authorities, together with approval and labeling selections; the precise time it takes to make regulatory submissions for vadadustat to well being authorities, together with the submission of the NDA to the FDA and the submission of the MAA to the EMA; dangers related to the Precedence Evaluation Voucher for vadadustat; the potential direct or oblique impression of the COVID-19 pandemic on our enterprise, operations, and the markets and communities through which we and our companions, collaborators, distributors and prospects function; manufacturing and high quality dangers; dangers related to administration and key personnel modifications and transitional intervals; the precise funding required to proceed to commercialize our business product, to develop and commercialize vadadustat, and to function the Firm; market acceptance and protection and reimbursement of our business product and vadadustat, if permitted; the dangers related to potential generic entrants for our business product and vadadustat, if permitted; early termination of any of Akebia’s collaborations; Akebia’s and its collaborators’ means to fulfill their obligations beneath Akebia’s collaboration agreements; the aggressive panorama for our business product and vadadustat; the scope, timing, and end result of any authorized, regulatory and administrative proceedings; modifications within the financial and monetary situations of the companies of Akebia and its collaborations companions and distributors; and Akebia’s means to acquire, keep and implement patent and different mental property safety for our business product, vadadustat and every other product candidates. Different dangers and uncertainties embrace these recognized beneath the heading “Threat Components” in Akebia’s Quarterly Report on Type 10-Q for the quarter ended June 30, 2020 and different filings that Akebia might make with the U.S. Securities and Change Fee sooner or later. These forward-looking statements (besides as in any other case famous) communicate solely as of the date of this press launch, and Akebia doesn’t undertake, and particularly disclaims, any obligation to replace any forward-looking statements contained on this press launch.
Investor Contact Kristen Okay. Sheppard, Esq. Ir@akebia.com
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