Top 5 Kidney Related News from April 2019

RenalytixAI Developing AI-Enabled Clinical Diagnostic Products for Kidney Disease

RenalytixAI, a developer of artificial intelligence-enabled clinical diagnostics for kidney disease, has raised $29 million to support the development and commercialization of two product categories for the early detection of kidney disease and accurate management of kidney transplant rejection. The launch of the first product, KidneyIntelX™, is planned for 2019; the launch will be conducted in collaboration with the Icahn School of Medicine at Mount Sinai, the medical school of the Mount Sinai Health System.

RenalytixAI began trading publicly on AIM, a market of the London Stock Exchange, on November 6, 2018, following the successful completion of the fundraising.

In a press release from RenalytixAI, James McCullough, chief executive officer, said, “RenalytixAI now has the financial resources to drive advanced diagnostic development to improve the management and cost of kidney disease. We are grateful to our investors and medical collaborators who are committed to reducing the impact of this disease.”

Erik Lium, PhD, executive vice president of Mount Sinai Innovation Partners, said, “We’re pleased to be collaborating with RenalytixAI, an emerging industry leader in health AI, on the development of breakthrough prognostics and diagnostics for renal disease. Renal disease represents an increasing healthcare crisis globally, and early detection and intervention can change the course of this disease.”

The technical platform will draw from distinct sources of health data, including systems containing extensive electronic health records, predictive blood-based biomarkers and other genomic data from analysis by high-performance, learning computer algorithms. By combining these inputs, RenalytixAI can create novel models for predicting disease progression and drug/therapy response in individual patients. The company will submit KidneyIntelX to the US Food and Drug Administration for regulatory review.

ClearGuard® HD Caps Reduce Bloodstream Infections

Results from a 2017 study reported in the American Journal of Kidney Diseases demonstrated that ClearGuard® HD Antimicrobial Barrier Caps were superior to standard hemodialysis caps in reducing central line-associated bloodstream infections; patients treated using the ClearGuard caps had an ~70% reduction in central line-associated bloodstream infections compared with standard hemodialysis caps. The study results were highlighted in a recent press release from Pursuit Vascular.

The press release also noted results of a 2018 study, reported in the Journal of the American Society of Nephrology, that compared use of ClearGuard caps to use of Tego® Connector + Curos™ Caps (control group). The findings were similar to those in the earlier study, with 63% to 82% reductions in central line-associated bloodstream infections with use of the ClearGuard cap.

Fresenius Medical Care North American Donates Record Funding for Kidney Walk Fundraisers

Fresenius Medical Care North America (FMCNA) has raised more than $800,000 for the Kidney Walk fundraiser sponsored by the National Kidney Foundation, according to a press release from Fresenius Medical Care and the National Kidney Foundation. Kidney Walk is the largest fundraising initiative fighting kidney disease in the United States.

The contribution from Fresenius included a $400,000 corporate donation and more than $400,000 in donations raised by FMCNA employees who participated in the walks. More than 5600 FMNCA employees joined approximately 400 teams at 71 Kidney Walks across the country.

Bill Valle, chief executive officer of FMCNA, said, “Our partnership with the National Kidney Foundation is one of the ways we live our mission to improve the quality of life of every patient every day. I am humbled by the incredible enthusiasm and support our employees demonstrated throughout the 2018 walks. This is just one of the many examples of how our teams go above and beyond every day to put our patients first.”

Kevin Longino, chief executive officer of the National Kidney Foundation and a kidney transplant recipient, said, “Exceeding this year’s fundraising goal is a big win for everyone affected by kidney disease and we’re proud of our partnership with FMCNA. Since 2012, FMNCA has been on the front lines with us in the fight to raise awareness about and find solutions for kidney disease, and to improve the lives of patients with kidney disease.”

The National Kidney Foundation holds walks in more than 100 communities; 81 cents of every dollar donated goes directly to support National Kidney Foundation programs and services.

Allena Pharmaceuticals Reaches Alignment with FDA on Phase 3 Program for Reloxaliase

Allena Pharmaceuticals has announced that the company has reached alignment with the FDA on the design of a phase 3 trial for reloxaliase in patients with enteric hyperoxaluria as well as an accelerated pathway to pursue a Biologics License Application (BLA) submission for reloxaliase. If approved, reloxaliase could be the first treatment for enteric hyperoxaluria approved by the FDA.

In a press release from Allena Pharmaceuticals, Alexey Margolin, PhD, chief executive officer, said, “We are very pleased with the outcome of our regulatory interactions and appreciate the FDA’s guidance in finalizing the design of our URIROX phase 3 program. As there is no precedent for the use of UOx excretion as a surrogate end point for kidney stone disease progression, the FDA’S engagement and specific feedback was essential during this process. We believe alignment on URIROX-2’s innovative trial design and disease-specific end points represents a watershed moment in the development of therapies for severe hyperoxaluria. We look forward to working with investigators, clinicians, and patient advocates as we advance reloxaliase as potentially the first therapeutic approved for patients with enteric hyperoxaluria.”

Craig Langman, MD, head of the division of kidney diseases at the Ann & Robert H. Lurie Children’s Hospital, Chicago, said, “Patients with enteric hyperoxaluria suffer from the sudden onset of debilitating kidney stone episodes in addition to the silent deposition of calcium oxalate crystals, both of which can damage the kidney, leading to progressive chronic kidney disease and ultimately end-stage renal disease. Based on the clinical data reported to date, I believe reloxaliase has the potential to offer a critical new therapeutic option to these patients, who currently have no approved pharmacologic interventions.”

Results of Treatment with H.P. Acthar Gel® for Post-Transplant Recipients with FSGS

In a press release, Mallinckrodt announced publication of results of a retrospective analysis assessing the efficacy of H.P. Acthar Gel® in kidney transplant patients with treatment-resistant focal segmental glomerular sclerosis (FSGS). Analysis results were reported in Transplantation. The analysis included data from patients treated at two large US transplant centers between April 2012 and December 2016.

The study evaluated 20 kidney transplant recipients (mean age, 49 years) who received H.P. Acthar Gel for the treatment of proteinuria due to new or recurrent post-transplant FSGS. The analysis found significant improvement in proteinuria following treatment; 50% of patients who received the gel had a complete or partial remission of proteinuria.