Study 206 Begins Treatment of Patients with ALLN-177 for Hyperoxaluria
Allena Pharmaceuticals, Inc., a late-stage biopharmaceutical company specializing in oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders, has announced that the first patients have been enrolled and are being treated in a phase 2 basket study of ALLN-177. According to a press release, Study 206 will evaluate ALLN-177 in adults and adolescents with primary hyperoxaluria, or enteric hyperoxaluria with advanced chronic kidney disease (CKD) and elevated plasma oxalate. ALLN-177 is a first-in-class, non-absorbed, orally administered enzyme that is designed to degrade oxalate within the gastrointestinal (GI) tract to treat severe hyperoxaluria.
The study will enroll 15 to 20 patients in the United States and Europe ≥12 years of age; treatment will continue for 12 weeks. Participants will self-administer 7500 units of ALLN-177 with each meal or snack five times per day. The end points are change from baseline in 24-hour urinary oxalate excretion and levels of plasma oxalate. Patients are currently being enrolled at clinical trial sites in the United States; enrollment will begin in the third quarter of 2018 at sites in Europe.
Alexey Margloin, PhD, CEO of Allena Pharmaceuticals, said, “ALLN-177 was designed to degrade oxalate in the GI tract. As a result, we believe ALLN-177 has the potential to reduce systemic oxalate absorption and decrease the renal oxalate burden in patients with severe hyperoxaluria and systemic manifestations of the disease…We look forward to garnering insights from this trial, as we work to address the unmet needs of patients with severe hyperoxaluria from whom there are currently no approved therapeutic options.”
ALLN-177 is also being evaluated in URIROX-1™, an ongoing phase 3 clinical trial in patients with hyperoxaluria who have normal kidney function or mild-to-moderate CKD. The US FDA has granted separate orphan drug designations to ALLN-177 for the treatment of primary hyperoxaluria and pediatric hyperoxaluria. ALLN-177 has also been granted orphan drug designation for the treatment of primary hyperoxaluria by the European Commission.
Cricket Health Names New Chief Medical Officer
Carmen Peralta, MD, MAS, has joined Cricket Health as chief medical officer. Dr. Peralta will lead the company’s medical team as it expands programs and its clinical footprint in the United States. She is professor of medicine at the University of California, San Francisco, and has served on Cricket Health’s medical advisory board.
According to a press release from Cricket Health, Dr. Peralta is a leader in epidemiology of kidney disease and hypertension, a pioneer in implementation sciences in nephrology, and has explored ways digital health and mHealth (mobile health) technology can improve care for patients with CKD.
Cricket Health is a specialty care provider for patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD). The company provides scalable programs focused on delaying progression of CKD, ensuring optimum outpatient transitions to renal replacement therapy, and supporting patients with ESRD in their chosen therapy. The programs are all designed with an eye toward putting patients in charge of their lives and providing hope for a better future.
In a company press release, Arvind Rajan, CEO and cofounder, said, “[Dr. Peralta] is a world-class clinician and researcher and over the past three years she has played a critical role not only in developing our clinical programs, but in shaping our strategic vision. As we’ve worked closely with her, we’ve seen first-hand her passion for doing what is right for patients…We are proud to welcome her to our leadership team, and look forward to working together to profoundly change the lives of patients around the country.”
Dr. Peralta said, “I have dedicated my career to improving the lives of those with kidney diseases—from prevention and early detection to management of CKD. Patients today need to understand how to best care for themselves, and the variety of treatments they have available. I look forward to working with Cricket Health to vastly improve the care for all persons with CKD and ESRD today and long into the future.”
Positive Efficacy Findings Bring Early Close to CREDENCE Trial
Positive efficacy findings have brought an early stop to the phase 3 CREDENCE trial. CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) was designed to test the efficacy and safety of INVOKANA® (canagliflozin) compared with placebo when used in addition to standard of care for patients with chronic kidney disease (CKD) and type 2 diabetes.
The decision to stop the trial was announced in a press release from the Janssen Pharmaceutical Companies of Johnson & Johnson. According to the release, the decision was based on a recommendation from the study’s Independent Data Monitoring Committee that met to review the data during a planned interim analysis. The data demonstrated that the trial had achieved prespecified criteria for the primary composite end point of end-stage renal disease (time to dialysis or kidney transplantation), doubling of serum creatinine, and renal or cardiovascular death, when used in addition to standard of care.
Co-chair of the CREDENCE Steering Committee, Vlado Perkovic, MBBS, PhD, FASN, FRACP, said, “Nearly half of all people with type 2 diabetes will develop chronic kidney disease, causing a high risk of kidney failure and cardiovascular disease, and impacting their quality and length of life, even with the current best available care. This huge unmet need is why it was so important for us to initiate the landmark CREDENCE renal outcomes trial over four years ago. We have accepted the advice of the Independent Data Monitoring Committee to stop the CREDENCE trial early due to demonstration of efficacy, and look forward to sharing the findings as soon as possible.”
CREDENCE is the first trial dedicated to renal outcomes in patients with CKD and type 2 diabetes against the background of standard of care. The trial enrolled approximately 4400 patients with type 2 diabetes and estimated glomerular filtration rate (eGFR) ≥39 to ≤90 mL/min/1.73 m2, and advanced albuminuria.
James List, MD, PhD, global therapeutic area head, cardiovascular & metabolism at Janssen Research & Development, LLC, said, “Chronic Kidney Disease is a progressive condition that impacts a person’s overall health and well-being, and with millions of people worldwide with the disease, we know that there is a clear need for new treatment options. We are excited about the possibility of bringing forth INVOKANA (canagliflozin) as the first therapy to treat patients with chronic kidney disease and type 2 diabetes in more than 15 years. We look forward to presenting the full data from the CREDENCE trial at an upcoming medical meeting and with health authorities in the near future.”
The press release noted that at this time, INVOKANA is contraindicated for patients with severe renal impairment (eGFR <30 mL/min/1.73 m2), end-stage renal disease, or patients on dialysis. In addition, INVOKANA is not recommended when eGFR is persistently <45 mL/min/1.73 m2.
Renal Research Institute Expands NYC Renal Research Laboratory
Fresenius Medical Care North America (FMCNA) has announced the expansion of its Renal Research Institute’s (RRI) New York City research laboratory. The expansion will enable RRI to “broaden its research capabilities in the renal space,” according to an announcement from FMCNA. The New York City facility is the “first FMCNA lab of its kind and it is equipped with the interdisciplinary team, skill set, and state-of-the-art technologies needed to improve the delivery of life-sustaining dialysis therapy for end-stage renal disease patient,” the announcement added.
The laboratory will support and connect RRI’s computational biomedicine work with clinical research. Insights from bench tests in the laboratory will inform the mathematical modeling efforts, and models will then be validated in the laboratory prior to entering clinical studies. The team will collaborate to “simulate life-sustaining dialysis therapy, with the goal of developing therapeutic methods that can be built into dialysis machines and equipment used in clinics to make the delivery of dialysis safer and more effective,” the announcement added.
Study Findings of ClearGuard HD Caps Receive AJKD Editor’s Award
An article in the American Journal of Kidney Diseases (AJKD), the official journal of the National Kidney Foundation, has received the AJKD Editor’s Choice award for outstanding publication in 2017. According to a press release from Pursuit Vascular, Inc., the article, Dialysis Catheter-Related Bloodstream Infections: A Cluster-Randomized Trial of the ClearGuard HD Antimicrobial Barrier Cap, Hymes et al., was “chosen for this award because of the significance of the findings to the nephrology field.”
Pursuit Vascular is the manufacturer of the ClearGuard HD cap, an antimicrobial device for catheter-based dialysis patients. The study reported in the AJKD was conducted by Frenova® Renal Research, a division of Fresenius Medical Care North America. Use of the ClearGuard HD cap was compared to standard caps in hemodialysis patients with central venous catheters (CVCs). The primary end point of interest was positive blood cultures as an indicator of bloodstream infections.
The ClearGuard HD cap is the only device cleared for sale in the United States that kills infection-causing bacteria inside a CVC hub. Results of the study demonstrated the superiority of ClearGuard HD caps to standard caps in patients with CVCs.
Doug Killion, president and CEO of Pursuit Vascular, said, “This award recognized the crucial role that ClearGuard HD caps play in tackling the challenging and devastating complications of bloodstream infections in these patients. It’s an honor to receive such a distinction from the AJKD editorial team.”
Microtip Partnership Assay for Renal Testing Launched
Ortho Clinical Diagnostics, in collaboration with Diazyme Laboratories, Inc., is offering three new Microtip Partnership Assays. The Microtip Partnership Assay (MPA) program enables Ortho to validate and provide high value, esoteric testing. The three new assays are glycated serum protein, lipoprotein (a), and cystatin C.
Cystatin C is a key marker for early diagnosis of chronic kidney disease and is a complement to serum creatinine testing. The predictive accuracy for all-cause mortality and progression to end-stage renal disease can be improved by combining cystatin C and serum creatinine testing; the combination is a more sensitive marker in the “creatinine blind range” in kidney testing, according to a press release from Ortho Clinical Diagnostics.
Katherine M. Wang, MD, Named AKF Clinical Scientist in Nephrology
The American Kidney Fund (AKF) has named Katherine M. Wang, MD Clinical Scientist in Nephrology (CSN) fellow for 2018-2019. Dr. Wang is a second-year nephrology fellow at Stanford University. The CSN grant will fund her research in the effects of intensive treatment of hypertension in patients with chronic kidney disease and the factors associated with the inability to reach lower systolic blood pressure targets.
A patient-orientated portion of Dr. Wang’s research will study patients with hypertension seen at Stanford Health Care, comparing protocol from the SPRINT (Systolic Blood Pressure Intervention Trial) study for blood pressure measurement with other modalities used in routine clinical practice.
In a press release from the AKF, Dr. Wang said, “My research as an American Kidney Fund Clinical Scientist in Nephrology fellow will provide valuable insights into patient subgroups that may pose significant challenges in terms of achieving more intensive blood pressure targets. I am grateful to AKF and its commitment to fostering health care access, health literacy, and the prevention and early detection of kidney disease.”