BioWorld International Correspondent

Sanos Bioscience A/S, a company spun out at the beginning of the year by Nordic Bioscience A/S, raised $10 million to fund further clinical development of glucagon-like peptide 2 (GLP-2) as a treatment for osteoporosis in postmenopausal women.

Scandinavian Life Science Venture and SEB Företagsinvest provided the funding. Nordic Bioscience, formed in 2001 via a merger of Osteopro A/S and Osteometer BioTech A/S, has retained a 40 percent stake in the new venture, Sanos CEO Dennis Henriksen told BioWorld International.

Sanos was established as a unit, he said, because neither component of Nordic Bioscience had a background in clinical development. Osteopro had focused on bone biology and on target discovery, while Osteometer had focused on diagnosis and the development of biomarkers to monitor bone turnover.

The use of GLP-2, a peptide hormone secreted by the intestine following food intake, in osteoporosis arose out of the latter work. Initial single-dose studies involving 60 healthy volunteers indicate that GLP-2 appears to reduce bone resorption, while having a favorable effect on new bone formation, Henriksen said.

The company plans to undertake a 14-day Phase Ib trial involving 120 volunteers by year's end. If successful, the company will undertake a Phase IIa trial in osteopenic women (borderline osteoporosis cases) in 2005.

Bone resorption and bone formation exhibit circadian variation, Henriksen said. Bone resorption peaks during fasting periods, as calcium is harvested from bone matrix in order to maintain homeostasis.

"The thing in bone biology everyone has been speaking about for 20 years is that the bone-remodeling process is a coupled process," he said. The theory is that some form of feedback exists between osteoblasts, which are responsible for bone matrix formation, and osteoclasts, which are responsible for bone matrix breakdown. Henriksen, formerly vice president of research and development at Nordic Bioscience, said that GLP-2 might be involved in that coupling.

Sanos is pursuing an outsourced business model and has a staff of just six. Its sole focus is on the GLP-2 program, Henriksen said, although it is looking at alternative administration routes of GLP-2 in parallel to the main clinical development work. The formulation of the 34-amino-acid peptide requires subcutaneous injection.