Kyowa Hakko Kirin : Announcement of Start of Phase 1 Joint Japanese-Korean Study of a Human Monoclonal Anti-FGF23 Antibody (KRN23) in X-linked Hypophosphatemic Rickets/Osteomalacia in Adults
July 29, 2014 at 03:17 am EDT
Share
July 29, 2014
Tokyo, Japan, July 29, 2014 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo; 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced the start of a phase 1 study of anti-fibroblast growth factor 23 (FGF23) *1 monoclonal antibody KRN23 in adult patients with X-linked hypophosphatemic rickets/osteomalacia (XLH) *2 that is presently under development. The study is to be conducted as an Asian clinical trial between Japan and South Korea.
KRN23 is an anti-FGF23 fully human monoclonal antibody produced by Kyowa Hakko Kirin. It is intended to increase the blood concentration of phosphorus by binding to FGF23, which is produced in excess in patients with XLH, and then inhibiting its action to increase reabsorption of phosphorus in renal tubules. Data from a phase 1 single-dose study and phase 1/2 repeated-dose studies of KRN23 in adult XLH patients have been presented at multiple medical conferences.
With this background, Kyowa Hakko Kirin has begun a phase 1 study in adult XLH patients in Japan and South Korea. This study is a multicenter, sequential dose-escalation, open-label, single-dose study that mainly investigates the safety and tolerability of KRN23, and the target number of subjects is 15.
The Kyowa Hakko Kirin Group is contributing to the health and prosperity of the world's people by pursuing advances in life sciences and technology and creating new value.
*1 Fibroblast growth factor 23 (FGF23)
FGF23 is a polypeptide consisting of 251 amino acids that is mainly produced in bone tissue. It acts upon the kidneys to inhibit the reabsorption of phosphorus in renal tubules. In recent years, there have been suggestions that FGF23 is involved in such diseases as hypophosphatemic rickets, neoplastic osteomalacia, and renal failure.
*2 X-linked hypophosphatemic rickets/osteomalacia (XLH)
XLH is a rare disease in which the patient develops hypophosphatemia when phosphorus is excreted by the body in excess because of a high concentration of FGF23 in the blood, and as a result, the growth and maintenance of bone is impeded.
Overview of this study
Target Disease/Population
XLH patients (aged 18 or older)
Study Design
Multicenter, sequential dose-escalation, open-label, single-dose study (Administration of single subcutaneous dose of KRN23 in the amount of 0.3, 0.6, or 1.0 mg/kg)
Planned Number of Subjects
15 patients
Location
Japan, South Korea
Primary Objective
Safety (adverse events, laboratory test values)
Appendix: Current clinical studies of KRN23
Phase 1 Study
in Japan and South Korea
Phase 2 study
in the US and EU(collaborating with Ultragenyx Pharmaceutical Inc.)
Target Disease/Population
Adult XLH patients
(aged 18 or older)
Pediatric XLH patients
(aged 5-12)
Study Design
Multicenter, sequential dose-escalation, open-label, single-dose study
Randomized, multicenter, open-label, dose finding, Phase 2 study
Planned Number of Subjects
15 patients
30 patients
Location
Japan, South Korea
US, UK, France, Netherlands
Primary Objective
Safety
Efficacy and Safety
ClinicalTrials.gov Identifier
NCT02181764
NCT02163577
Contact:
Kyowa Hakko Kirin
Media Contact:
+81-3-3282-1903
or
Investors:
+81-3-3282-0009
Kyowa Kirin Co., Ltd. specializes in the development, manufacturing and marketing of pharmaceutical and biochemical products. Net sales break down by source of revenue as follows:
- sales of pharmaceutical products (92.6%): prescription products for anemia, cancers, immune and nephrology diseases treatment;
- sales of licenses (7.4%).
At the end of 2021, the group had 3 production sites located in Japan (2) and China.
Net sales break down geographically as follows: Japan (60.9%), Asia (9%), Americas (16.3%) and Europe (13.8%).
Kyowa Hakko Kirin : Announcement of Start of Phase 1 Joint Japanese-Korean Study of a Human Monoclonal Anti-FGF23 Antibody (KRN23) in X-linked Hypophosphatemic Rickets/Osteomalacia in Adults