September 2019 News Briefs

Tamara Kear Named ANNA Executive Director

Tamara Kear, PhD, RN, CNS, CNN, has been named executive director of the American Nephrology Nurses Association (ANNA). Currently ANNA’s president, Dr. Kear will assume her new position at Anthony J. Jannetti, Inc. (AJJ, Inc.), on January 1, 2020. AJJ, Inc. provides full-service management services to ANNA. As executive director, Dr. Kear will oversee all operations and strategic planning for ANNA. She has been an active ANNA member for nearly 30 years, according to a press release from the association.

Lillian Pryor, MSN, RN, CNN, elected by ANNA members as president-elect in December 2018, will assume the role of president for a 15-month term. The interim executive director, Lou Ann Leary, will remain in that role until Dr. Kear takes over in January.

Tony Jannetti, chairman at AJJ, Inc., said, “I’m very pleased to welcome Dr. Tamara Kear to Anthony J. Jannetti, Inc. Her experience, vision, and proven leadership will be tremendous assets as she joins our team to provide association management services to ANNA.”

Positive Results from AI-enabled Diagnostic Validation Study

Interim results from the KidneyIntelX™ expanded validation study have been announced in a press release from Renalytix AI. The KidneyIntelX artificial intelligence-enabled in vitro diagnostic uses a machine learning algorithm to examine results from proprietary blood biomarkers in combination with information from a patient’s electronic health record (EHR) to generate a rapid kidney function decline (RKFD) score. RKFD is defined as a change in kidney function (glomerular filtration rate) of at least 5 mL/min/1.73 m2 per year.

The expanded validation study includes stored patient plasma samples and corresponding EHRs from three academic medical centers: Emory University, the Ichan School of Medicine at Mount Sinai, and the University of Pennsylvania.

In the multi-center cohort of patients with type 2 diabetes, performance targets were met or exceeded by the KidneyIntelX algorithm. The algorithm identifies patients experiencing rapid decline in kidney function as well as patients who will progress to kidney failure and/or dialysis. The data will support the ongoing regulatory progress with the US Food and Drug Administration under Breakthrough Device designation, announced in May 2019.

Initial performance targets reported in April demonstrated that the ability to predict which patients went on to experience RKFD was significantly increased with the KidneyIntelX machine learning algorithm compared with currently used diagnostic methods. In the expanded validation study population, the positive predictive value of KidneyIntelX for RKFD in patients with type 2 diabetes exceeded 50% in patients who were in the highest 15% of the risk distribution, as well as a negative predictive value of >95% for patients unlikely to develop RKFD

Drug for Treatment of IgAN To Be Developed and Commercialized in China

In a recent press release, Calliditas Therapeutics AB and Everest Medicines II Limited announced a license agreement to develop and commercialize Nefecon in Greater China. Nefecon, a patented oral formulation of budesonide, is for the treatment of the chronic autoimmune kidney disease immunoglobulin A nephropathy (IgAN).

IgAN is an orphan disease in Europe and the United States; the prevalence in China is much higher. IgAN accounts for ~40% of primary glomerular diseases in China, making it the world’s largest market in terms of the number of patients with IgAN. Calliditas is conducting a pivotal, global phase 3 clinical trial for Nefecon for patients with IgAN. The announced agreement gives Everest Medicines exclusive rights to develop and commercialize the agent in China, Hong Kong, Macau, Taiwan, and Singapore.

“We are excited to be entering into this partnership with Everest Medicines to expand Nefecon’s market reach to China, where there is a significant unmet medical need for this large patient population,” said Renee Aguiar-Lucander, chief executive officer at Calliditas Therapeutics AB. “We look forward to working in close collaboration with Everest Medicines to bring the innovative approach of Nefecon, which has shown great promise in our large phase 2b study, to IgAN patients as  rapidly as possible.

Ian Woo, president and chief financial officer of Everest Medicines, said, “We look forward to partnering with Calliditas to develop and commercialize Nefecon as a potential novel therapy for the treatment of IgAN. Calliditas’ strong foundation of clinical development of Nefecon, coupled with Everest’s local clinical and regulatory expertise lays the groundwork for expediting the development of this promising therapeutic candidate as a potential treatment option for patients in Greater China and Singapore suffering from IgAN.”

The first 200 randomized patients in the ongoing study will form the basis for topline data readout expected to occur during the second half of 2020. Calliditas will then submit applications for accelerated/conditional regulatory approval to the US Food and Drug Administration and the European Medicines Agency respectively.

Outset Medical Names Rebecca Chambers CFO

Rebecca Chambers has been named chief financial officer at Outset Medical, according to a press release. Outset Medical is a commercial-stage company that delivers state-of-the-art technology to the growing global dialysis market.

Ms. Chambers comes to Outset from Illumina, a leader in DNA sequencing technology, where she held numerous financial positions, including clinical financial planning and analysis and investor relations.

Leslie Trigg, chief executive officer at Outset, said, “Rebecca’s deep capital markets expertise and growth-company track record is ideally suited to our stage of commercial expansion. We recognized in Rebecca a best-in-class ability to build a strong financial foundation and effective, transparent relationships with the investment community. We are thrilled to welcome her to the leadership team.”

“I am honored to be a part of Outset at this time in its growth trajectory. It is a rare opportunity to join a team passionate about transforming a stagnant, but rapidly growing market with a huge unmet patient need,” Ms. Chambers said. “The Tablo Hemodialysis System has the potential to fundamentally change the way dialysis is delivered and improve the lives of patients and providers, while also driving significant cost efficiencies.” The Tablo system is an all-in-one dialysis clinic on wheels designed to reduce the cost and complexity of dialysis and improve the experience for patients and providers.

Fresenius Medical Care to Open Distribution Center in Tennessee

In a recent press release, Fresenius Medical Care announced groundbreaking for a new distribution center in Knoxville, Tennessee. The center will support the company’s efforts to increase the number of patients with kidney failure who opt for treatment with home dialysis. The facility will be the largest on the East Coast and will support more than 120 new jobs and allow for future growth in the company’s manufacturing plant that opened nearby in 2016. The plant produces peritoneal dialysis solution and other supplies for home and clinical dialysis.

“We are making a strong commitment to expanding access to home dialysis and empowering our patients to choose the treatment option that works best for their individual needs,” Rice Powell, chief executive office of Fresenius Medical Care, said. “This new distribution center under construction is critical to that effort and will allow us to better serve the needs of thousands of people living with kidney failure across the country. The support from the Knoxville community, which includes so many business and government partners, has been a huge part of our success, and we thank everyone who helped make this groundbreaking possible.”

Rhonda Rice Clayton, executive vice president of the Knoxville Chamber, said, “We are proud to celebrate this milestone and our partnership with Fresenius Medical Care. Today’s groundbreaking exemplifies the long-term, positive impact a collaborative approach to economic development can have on a company and on a community. We appreciate the efforts of Knox County officials and our regional partners in making it possible for Fresenius Medical Care to expand their investment in Innovation Valley.”

AKF and AstraZeneca Partner in Hyperkalemia Awareness and Education Campaign

The American Kidney Fund (AKF) has announced that AstraZeneca is the founding supporter of an education and awareness campaign designed to increase the understanding of hyperkalemia. Hyperkalemia, high potassium level, is a common and serious complication of kidney disease, associated with muscle cramps, nausea, lethargy, difficulty breathing, irregular heartbeat, and heart attacks. The campaign will also include continuation of AKF’s efforts to educate patients on nutrition and limiting intake of foods high in potassium in patients with high risk of hyperkalemia.

In a press release from AKF, LaVarne A. Burton, president and chief executive officer, said, “For patients dealing with the complications of kidney disease, including hyperkalemia, navigating the complex relationship between diet and medication is challenging. We are extraordinarily grateful to AstraZeneca for its partnership in working with us to empower patients with the knowledge they need to have the best possible health outcomes.”

Tony Silfani, PhD, executive director and US head of marketing, renal, at AstraZeneca, said, “AstraZeneca is proud to partner with the American Kidney Fund on this important effort to increase awareness and understanding of chronic kidney disease and its associated complications. Today, there is a limited level of understanding of the role potassium can play in the body and its potential dangers for those with kidney or cardiovascular conditions, and we believe this initiative aligns with our commitment to advance this critical dialogue to the renal community.”

Cara Therapeutics Announces Results from Phase 3 Trial of KORSUVA™ Injection for Pruritis

Positive topline data from the KALM-1 pivotal phase 3 trial of KORSUVA™ (CR845/difelikefalin) Injection in hemodialysis patients with moderate-to-severe chronic disease-associated pruritis (CKD-aP) has been released from Cara Therapeutics, Inc., a biopharmaceutical company that focuses on development and commercialization of new chemical entities with a primary focus on the treatment of pruritis.

“We are extremely pleased with the robust topline results from our first pivotal phase 3 trial of KORSUVA Injection and are particularly encouraged by the early anti-pruritic response with KORSUVA Injection, which resulted in statistically significant separation from placebo after only 1 week of treatment and a sustained significant benefit through 12 weeks,” Derek Chalmers, PhD, DSc, president and chief executive officer of Cara Therapeutics, said in a press release. “We look forward to reporting topline data from our second global phase 3 trial, KALM-2, in the second half of this year and, assuming positive results, moving towards an NDA submission as quickly as possible thereafter.”

CKD-aP is a systemic itch condition that occurs with high frequency and intensity in patients undergoing hemodialysis or peritoneal dialysis. Approximately 40% of patients with end-stage renal disease experience CKD-aP.

Steven Fishbane, MD, chief, division of kidney disease and hypertension, Northwell Health, and professor of medicine at Hofstra/Northwell, and a KALM-1 clinical investigator, said, “Itching is a significant problem for many of our hemodialysis patients and there is an unmet need for an effective treatment. I am impressed by the clinically meaningful efficacy demonstrated in this study. Relative to the favorable safety data, these results suggest that, if approved, this can be an important drug that could help many of our patients.”

Allena Pharmaceuticals Report Interim Data from Study 206 of Relaxoliase

Interim data from Study 206, an ongoing phase 2 basket clinical trial of reloxaliase have been reported by Allena Pharmaceuticals. Reloxaliase is in development for the treatment of primary hyperoxaluria (PH) and enteric hyperoxaluria (EH) in patients with chronic kidney disease. Patients with EH treated with reloxaliase in Study 206 demonstrated a substantial treatment effect, according to a press release from Allena.

Louis Brenner, MD, president and chief executive officer of Allena Pharmaceuticals, said, “We are pleased to see a robust response to reloxaliase in EH patients suffering from advanced stages of the disease. We believe this reflects reloxaliase’s activity and novel mechanism of action of degrading oxalate within the GI tract, which is well-targeted to treat excess oxalate absorption driven by an underlying GI disorder. The potential to alleviate the high oxalate burden on these patients is very encouraging. To our knowledge, this is a first demonstration of a specific pharmacologic therapy leading to reduction in plasma oxalate and urinary oxalate levels in patients with EH and decreased kidney function.”

Study 206 is a multi-center, open-label, single-arm, phase 2 clinical trial designed to enroll between 15 and 20 patients in the United States and Europe. Patients orally administer 7500 units of reloxaliase with each meal or snack five times a day, for 12 consecutive weeks. The primary endpoints are change from baseline in 24-hour urine oxalate excretion and plasma oxalate levels.