CAMBRIDGE, Mass., Aug. 4, 2022 /PRNewswire/ — Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical firm with the aim to raised the lives of individuals impacted by kidney illness, as we speak introduced preliminary findings from an investigator-sponsored examine evaluating vadadustat, Akebia’s investigational oral hypoxia-inducible issue prolyl hydroxylase inhibitor (HIF-PHI), for the prevention and therapy of ARDS in medical trial topics with COVID-19 and hypoxemia (O2 saturation ≤94%). The VSTAT trial (Vadadustat for the Prevention and Therapy of ARDS in Hospitalized Sufferers with Coronavirus Illness 2019) was a section 2, randomized, double-blind, placebo-controlled trial, carried out by The College of Texas Well being Science Heart at Houston (UTHealth) in Houston, Texas and partially funded by Akebia.
The trial enrolled 449 grownup topics at 5 hospitals who have been randomized 1:1 to vadadustat 900 mg or placebo as soon as per day orally for as much as 14 days whereas hospitalized. The VSTAT trial measured the proportion of topics with both 6 (non-invasive air flow or excessive movement oxygen units), 7 (invasive mechanical air flow or extracorporeal membrane oxygenation), or 8 (demise) on the Nationwide Institute of Allergy and Infectious Illness Ordinal Scale (NIAID-OS) at Day 7 and Day 14 (major). Whereas a smaller proportion of topics within the vadadustat group had a rating of 6, 7, or 8 on the NIAID-OS than within the placebo group at Day 14, the trial failed to satisfy its major superiority threshold of >95% likelihood. These receiving vadadustat; nonetheless, did exhibit 94% likelihood for conferring profit on the NIAID-OS at Day 14.
At Day 14, the proportions of topics who had a 6, 7 or 8 on the NIAID-OS have been 13.3% (9.6%, 17.7%; 2.5, 97.5 percentiles from Bayesian simulations) for vadadustat versus 16.9% (12.6%, 22.0%) for placebo with a relative danger of 0.79 and 94% likelihood that vadadustat was superior to placebo. In a pre-specified evaluation at Day 7, the proportions of topics who had a 6, 7 or 8 on the NIAID-OS have been 25.4% (20.7%, 30.5%) for vadadustat versus 29.7% (24.5%, 35.3%) for placebo with a relative danger of 0.86 and 97% likelihood that vadadustat was superior to placebo.
The incidence of therapy emergent hostile occasions was 78.6% within the vadadustat group and 76.2% within the placebo group. The commonest therapy emergent hostile occasions reported in vadadustat/placebo topics have been alanine aminotransferase enhance (34.4%/28.7%), COVID-19 pneumonia (19.5%/27.4%), anemia (14.0%/17.0%), aspartate aminotransferase enhance (14.0%/14.8%), hyponatremia (10.7%/15.7%), septic shock (11.6%/10.8%), hyperkalemia (10.2%/10.8%), and hypermagnesemia (7.0%/13.9%). The incidence of great therapy emergent hostile occasions was 27.9% within the vadadustat group and 32.7% within the placebo group. The commonest critical therapy emergent hostile occasions reported in vadadustat/placebo topics have been COVID-19 pneumonia (19.5%/27.4%) and septic shock (11.6%/10.8%).
“Whereas the trial missed its prespecified major endpoint at Day14, we’re extraordinarily inspired by the info and consider they help additional growing vadadustat as a therapy for ARDS attributable to COVID-19 or different causes,” mentioned John P. Butler, Chief Government Officer of Akebia. “I need to thank UTHealth for delivering a well-executed medical trial throughout this tough interval. We additionally need to thank the sufferers who participated within the trial. We are going to now work to assessment the total knowledge set extra completely, seek the advice of with consultants within the area and finally seek the advice of FDA on a possible path ahead.”
Akebia is working with UTHealth Houston on publication of the total trial outcomes and figuring out subsequent steps in growing vadadustat as a possible therapy for ARDS attributable to COVID-19 or different causes.
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 info, please go to our web site at www.akebia.com, which doesn’t type part of this launch.
Vadadustat is an oral hypoxia-inducible issue prolyl hydroxylase 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 might result in elevated purple blood cell manufacturing and improved oxygen supply to tissues. Vadadustat is an investigational new drug and isn’t authorized by the U.S. Meals and Drug Administration (FDA). On March 29, 2022, the FDA issued an entire response letter to Akebia’s New Drug Software for vadadustat for the therapy of anemia attributable to persistent kidney illness (CKD). Vadadustat is at present underneath assessment by the European Medicines Company for the therapy of anemia attributable to CKD in adults. In Japan, vadadustat is authorized as a therapy for anemia attributable to CKD in each dialysis-dependent and non-dialysis dependent grownup sufferers.
Statements on this press launch relating to Akebia Therapeutics, Inc.’s (“Akebia’s“) technique, plans, prospects, expectations, beliefs, intentions and targets are forward-looking statements throughout the that means of the U.S. Non-public Securities Litigation Reform Act of 1995, as amended, and embody, however should not restricted to, statements relating to: Akebia’s growth plans for vadadustat and analysis of vadadustat as a possible therapy for ARDS attributable to COVID-19 or different causes. The phrases “consider,” “plan,” “potential,” “will,” “proceed,” derivatives of those phrases, and comparable references are supposed to establish forward-looking statements, though not all forward-looking statements comprise these figuring out phrases. Precise outcomes, efficiency or expertise might differ materially from these expressed or implied by any forward-looking assertion on account of varied dangers, uncertainties and different components, together with, however not restricted to, dangers related to: vadadustat is probably not an efficient therapy to deal with ARDS or different causes or be authorized for advertising and marketing by the FDA; the direct or oblique influence of the COVID-19 pandemic on regulators and Akebia’s enterprise, operations, and the markets and communities during which Akebia and its companions, collaborators, distributors and prospects function; the chance that medical trials is probably not profitable; manufacturing dangers; dangers related to administration and key personnel modifications and transitional durations; the precise prices incurred within the medical trials of vadadustat and the supply of financing to cowl such prices; the chance that medical trials are discontinued or delayed for any purpose, together with for security, tolerability, enrollment, manufacturing or financial causes; market acceptance and protection and reimbursement of vadadustat, if authorized; the dangers related to potential generic entrants; the timing and content material of choices made by regulatory authorities; the aggressive panorama; the scope, timing, and consequence of any authorized, regulatory and administrative proceedings; the precise time it takes to provoke and full preclinical and medical research; modifications within the financial and monetary situations of the companies of Akebia and its companions; and Akebia’s and its companions’ capacity to acquire, keep and implement patent and different mental property safety. Different dangers and uncertainties embody these recognized underneath the heading “Danger Components” in Akebia’s Quarterly Report on Kind 10-Q for the quarter ended March 31, 2022, and different filings that Akebia might make with the U.S. Securities and Alternate 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, besides as required by regulation, Akebia doesn’t undertake, and particularly disclaims, any obligation to replace any forward-looking statements contained on this press launch.
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