SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--KAI Pharmaceuticals, Inc., a privately held drug discovery and development company, today announced initiation of patient enrollment in the second Phase 2 study of KAI-4169, a novel pharmaceutical agent being tested for the treatment of chronic kidney disease-mineral and bone disorder (CKD-MBD) in hemodialysis patients with secondary hyperparathyroidism (SHPT), which is a frequent and serious complication of end-stage renal disease (ESRD).
The single-arm, open-label, multicenter, dose-titration study is designed to evaluate the effect of three times weekly intravenous bolus administration of KAI-4169 over a 12-week treatment period as assessed by percent change in parathyroid hormone (PTH) from baseline at the end of treatment. Secondary endpoints include proportion of subjects with ≥ 30% reduction in PTH from baseline, the proportion of subjects with PTH ≤ 300 pg/mL and the mean change from baseline in serum calcium and phosphorus.
Steven James, President and CEO of KAI, commented, “We are proud of the momentum and continued progress of KAI-4169, our lead program. We recently reported results of the first Phase 2 study of KAI-4169 at the annual meeting of the American Society of Nephrology in a late breaker poster presentation. We believe KAI-4169 may lead to greatly improved care for patients, and we look forward to reporting continued positive results and progress of our program.”
About CKD-MBD
In the U.S., there are roughly 600,000 patients with Stage 5 CKD and eight million patients with Stage 3/4 disease. CKD-MBD often develops early in CKD and worsens as renal function declines and the disease progresses. Most ESRD patients on hemodialysis are affected by CKD-MBD, which can lead to significant morbidity and mortality, including bone pain and fractures, vascular calcification and cardiovascular events.
About KAI-4169
Previous Phase 2 data have demonstrated that KAI-4169 was highly effective in the treatment of CKD-MBD and resulted in sustained reductions in PTH, calcium and FGF-23. The data also demonstrated that KAI-4169 was very well-tolerated. No subjects discontinued due to adverse events, and the incidence of gastrointestinal adverse events was similar in the KAI-4169 and placebo treatment groups.
About KAI Pharmaceuticals
KAI is a clinical-stage, biopharmaceutical company with a lead peptide product candidate, KAI-4169, in development for the treatment of CKD-MBD. Building on positive, earlier-stage clinical data, KAI has initiated its second Phase 2 study of KAI-4169 in hemodialysis patients. Further, KAI entered into a partnership with Ono Pharmaceutical Co., Ltd. wherein Ono will develop and commercialize KAI-4169 in Japan. In addition, KAI is conducting preclinical research on pre-hemodialysis applications of KAI-4169.
KAI’s leadership team has a strong background and track record in successful product development and commercialization. The Company is backed by a leading syndicate of venture investors, having raised $63 million in Series A and B rounds. KAI is headquartered in South San Francisco, California, and can be found online at www.kaipharma.com.