KAI Pharmaceuticals, Inc., a privately held drug discovery and development company, announced enrollment of the first patients in a phase II study of KAI-4169, a novel pharmaceutical agent being tested for the treatment of Secondary Hyperparathyroidism (SHPT), which is a frequent and serious complication of End-Stage Renal Disease (ESRD).
The phase II study is a double-blind, randomized, placebo-controlled, multiple ascending dose study to assess the safety, tolerability and efficacy of multiple Intravenous (IV) doses of KAI-4169 administered during haemodialysis in patients with SHPT.
Results obtained in the study will be used to select the appropriate dosing regimen for further development of KAI-4169 for the chronic management of SHPT in ESRD patients. Previous phase I data demonstrated that single IV doses of KAI-4169 were safe and well-tolerated and resulted in sustained reductions in serum levels of Parathyroid Hormone (PTH) in both healthy male subjects and ESRD patients with SHPT.
“The KAI-4169 programme continues to advance as planned, and we expect to report data from the phase 2 study in the second half of this year,” commented Steven James, president and CEO of KAI. “The results to date have been encouraging in these hard-to-treat patients. The unmet medical need is compelling – elevated PTH exacerbates mineral imbalances (particularly calcium and phosphorus) in ESRD patients, and is linked to severe pathological effects such as osteodystrophy, vascular calcification, and increased risk for cardiovascular events, all of which contribute to morbidity and mortality in these patients.”
SHPT develops early in Chronic Kidney Disease (CKD) and worsens as renal function declines and progresses to ESRD. SHPT, which affects the vast majority of patients with ESRD, is associated with bone disease (high-turnover renal osteodystrophy) and cardiovascular disease (vascular calcification) and can lead to significant morbidity. In the US, there are roughly 350,000 and eight million patients with ESRD and CKD, respectively.
KAI is a clinical-stage, biopharmaceutical company with a lead peptide product candidate, KAI-4169, in development for the treatment of SHPT in patients with kidney disease.