Caladrius Biosciences Announces IDMC Recommendation to Advance CLBS201 Trial for the Treatment of Diabetic Kidney Disease

Caladrius Biosciences, Inc. recently announced the Independent Data Monitoring Committee (IDMC) overseeing the Phase 1b, open-label, proof-of-concept study of CLBS201 for the treatment of diabetic kidney disease (DKD) has reviewed the initial safety and tolerability data from the first two, sequentially treated, patients. Based on their assessment of the data, the IDMC approved proceeding with the enrollment of the remaining four patients in the study without further review.

“We are very pleased with the progress of the study and with the recommendations of the IDMC,” stated Kristen K. Buck, MD, Executive Vice President of R&D and Chief Medical Officer of Caladrius. “We find it encouraging that CLBS201 appeared to be well-tolerated based on the initial assessment of data. We look forward to continuing this study and hope to rapidly enroll the remaining patients, leading to top-line data by the first quarter of 2023.”

Progressive kidney failure is associated with attrition of the microcirculation of the kidney. Preclinical studies in kidney disease and injury models have demonstrated that protection or replenishment of the microcirculation results in improved kidney function. Based on these observations, the company recently initiated a Phase 1, open-label, proof-of-concept trial evaluating CLBS201, a CD34+ regenerative cell therapy investigational product for intra-renal artery administration in patients with DKD. Patients selected for the study will be in the pre-dialysis stage of kidney disease and will exhibit rapidly progressing stage 3b disease. The protocol provides for a staggered, sequentially dosed cohort of six patients overseen by an IDMC with the objective of determining the tolerance of intra-renal cell therapy injection in DKD patients as well as the ability of CLBS201 to regenerate kidney function. For more information on this study, please visit clinicaltrials.gov (identifier: NCT04990427).

DKD, also called diabetic nephropathy, is a serious kidney-related complication of diabetes. Diabetes mellitus is the leading cause of kidney disease; approximately 40% of individuals with diabetes have DKD. Over time, high blood sugar from poorly controlled diabetes can damage the small blood vessels (microvasculature) in the kidneys, which can lead to kidney damage. This microvascular complication may eventually develop in approximately 30% of patients with type 1 diabetes and approximately 40% of patients with type 2 diabetes. All-cause mortality in patients with DKD is reported to be higher than in patients with diabetes without kidney disease.

Caladrius Biosciences, Inc. is a clinical-stage biopharmaceutical company dedicated to the development of innovative therapies designed to treat or reverse disease. We currently are developing first-in-class autologous cell therapy products based on the finely tuned mechanisms for self-repair that exist in the human body. Our technology leverages and enables these mechanisms in the form of specific cells, using formulations and modes of delivery unique to each medical indication.

The company’s current product candidates include: XOWNA (CLBS16), the subject of both a recently completed positive Phase 2a study and an ongoing Phase 2b study (www.freedom-trial.com) in the US for the treatment of coronary microvascular dysfunction (CMD); CLBS12 (HONEDRA in Japan), recipient of a SAKIGAKE designation in Japan and eligible for early conditional approval for the treatment of critical limb ischemia (CLI) and Buerger’s disease based on the results of an ongoing clinical trial; and CLBS201, designed to assess the safety and efficacy of CD34+ cell therapy as a treatment for diabetic kidney disease (“DKD”). For more information, visit www.caladrius.com.

The company recently announced that it has signed a definitive merger agreement with Cend Therapeutics, Inc. (www.cendrx.com). The merger is expected to close in the third quarter of 2022.