Firms will continue to partner on Phase II diabetic foot ulcer trial.
Biomaterials firm Kuros Biosurgery regained its rights to a number of clinical-stage trauma and spinal repair candidates previously licensed to Baxter. The two firms will, however, continue to partner on development of a chronic wounds therapy candidate, KUR-211, which is currently in Phase II development in Europe in patients with diabetic foot ulcers.
The products regained by Kuros include KUR-111, KUR-113, and KUR-115. KUR-111 is an autograft replacement candidate that combines a fibrin matrix, variant parathyroid hormone (PTH), and hydroxyapatite/calcium phosphate granules. The product has demonstrated noninferiority to autograft in a Phase II tibial plateau fractures study involving 183 patients. KUR-113 comprises fibrin matrix and a variant PTH, and is designed to promote bone formation and accelerate fracture repair. Data reported separately today from a Phase II study in open tibial shaft fractures showed that in comparison with standard of care, KUR-113 significantly increased the proportion of patients who were healed at six months after surgery. Preclinical-stage product, KUR-115, is being prepared for clinical studies in spinal fusion patients.
The wound care product KUR-211, which Baxter and Kuros are continuing to co-develop, is a combination product in which an engineered variant of platelet-derived growth factor is applied to the wound in combination with a fibrin matrix. A large European Phase IIb clinical trial is evaluating the efficacy and safety of KUR-211 used as an adjunct to standard of care in patients with diabetic foot ulcers. Kuros has previously completed two clinical studies with KUR-211 in chronic wounds: one Phase I/II dose-finding study in venous ulcer patients, and an exploratory study in diabetic ulcer patients.