XORTX Therapeutics, a company founded to focus on developing therapies to treat progressive kidney disease, has filed a pre-IND (Investigational New Drug) meeting request with the FDA. The company, based in Calgary, Alberta, filed pre-IND documents and secured a September 2018 meeting with the FDA to discuss development of its compound, XRx-008, for the treatment of autosomal dominant polycystic kidney disease (ADPKD). The company currently plans to advance XRx-008 through phase 2 clinical trials.
Said XORTX’s CEO Allen Davidoff, MD: “We are excited to take this important first regulatory step in the development of the XRx-008 program for ADPKD. This
Baxter International, in Deerfield, IL, has released data from two independent studies that explored expanded hemodialysis therapy (HDx) with its Theranova™ dialyzer. Expanded hemodialysis refers to applying high retention-onset membranes able to filter out molecules in the mid- to high molecular weight range.
Nephros (South Orange, NJ) gained FDA approval in 2012 for its hemodiafiltration system, the first in the US. Whereas dialysis works on a diffusion principle and filters smaller molecules, hemodiafiltration provides an extra boost of cleansing because it moves molecules through a fluid under pressure and forces out the large waste molecules that might otherwise remain.
The U.S. Food and Drug Administration recently approved Pfizer’s biosimilar anemia drug, Retacrit (epoetin alfa-epbx). After two previous approval attempts, Retacrit was approved as a biosimilar to Epogen (Amgen) and Procrit (epoetin alfa, Johnson & Johnson).
Nephrologists as a group appear to be receptive to biosimilars for their patients. Spherix Global Insights reported their approval in a March 2018 survey of 202 nephrologists, especially if Retacrit use should become required by dialysis organizations. Only 22% of nephrologists surveyed agreed with the statement “I would not be pleased if my dialysis center switched to a biosimilar ESA.”
Tricida, a privately held company based in South San Francisco, announced positive results from its most recent trial, a Phase 3 study of TCRA-301 to examine the drug’s effects on metabolic acidosis in patients with chronic kidney disease (CKD). Tricida also filed for $150 million in an initial public offering to fund kidney drug approval.
Tricida’s new compound TRC101, a novel, non-absorbed polymer, is designed to bind hydrochloric acid in the gastrointestinal tract and remove it from the body through fecal excretion, thereby decreasing the total amount of acid in the body and increasing blood bicarbonate.
RenalGuard Solutions has announced results for an additional patient population with a form of heart failure. The Milford, MA, company demonstrated the ability of RenalGuard-Guided Diuretic Therapy to control and optimize fluid management in patients with acute decompensated heart failure. Heart failure is common in patients with CKD and end stage renal failure.
RenalGuard measures urine output and automatically infuses saline (hydration fluid) according to the ideal present fluid loss limits set by the physician.
Patients in the trial started with an initial 24 hours of standard treatment with furosemide (brand name Lasix, a loop diuretic), followed by 24 hours
Pharmacy giant CVS (Woonsocket, RI) recently announced that it will enter the kidney care market. The company will take a stepwise approach in a new initiative that will focus on chronic kidney disease and home-based dialysis.
The company’s first focus will be on patient education and early detection of kidney disease. It also plans to introduce a new home hemodialysis technology designed to make home hemodialysis simple and safe for patients, and to facilitate longer and more frequent treatments.
“While in-center dialysis clinics are currently the most common choice for hemodialysis treatment, published clinical research has shown improved cardiac health,
Otsuka Pharmaceutical’s drug Jynarque (tolvaptan) received US Food and Drug Administration (FDA) approval as the first drug treatment in the United States to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). The drug is a selective vasopressin V2-receptor antagonist.
Tolvaptan showed a greater reduction in estimated glomerular filtration rate compared to placebo, meeting the primary endpoint of the REPRISE trial (Replicating Evidence of Preserved Renal Function: an Investigation of Tolvaptan Safety and Efficacy in ADPKD).
The data appeared in a late-breaking abstract at ASN Kidney Week 2017 and were simultaneously published
Fresenius Medical Care North America (FMCNA, Waltham, MA), has launched a foundation to create awareness and a national dialog about chronic kidney disease (CKD) and transplantation.
The funding will come from FMCNA employees and medical staff and other individuals, with FMCNA pledging to match up to $1 million of contributions during the first year.
The nonprofit Fresenius Medical Care Foundation will address the social and economic conditions that increase the risk for developing CKD, with a focus on population health, childhood obesity, and transplant and donor awareness. The foundation will aim to engage with nonprofit organizations and with communities that
In mid-April 2018, Puerto Rico again experienced a total blackout, this time because of an electrical subcontractor’s mistake, not an act of nature like Hurricane Maria, which devastated the island in September 2017.
Many patients have to travel far—sometimes up to 12 hours—to find functional dialysis opportunities. In March 2018, Puerto Rico’s health secretary said the department was working to bring in mobile units for dialysis. Luis Emanuelli, regional vice president of Fresenius Kidney Care, said he is aware of plans for the mobile units but is unaware of the timeline for bringing them on line.
Two manufacturers reported on recent results in acute kidney injury (AKI) studies.
Biopharmaceutical company AM-Pharma, based in Bunnik, the Netherlands, announced that its phase II STOP-AKI study demonstrated a noteworthy reduction in mortality in a 28-day period. The company is focused on the development of recombinant human alkaline phosphatase (recAP) for the treatment of AKI, ulcerative colitis, and hypophosphatasia. Pfizer acquired a minority interest in AM-Pharma in May 2015 and may acquire the rest of the company through an option.
The 301-patient study compared a treatment group of sepsis patients with AKI with a similar group receiving placebo. Adding recAP