Oral salmon calcitonin using absorption-enhancing Eligen Technology holds promise for osteoarthritis

Oct 19 2009

Emisphere Technologies, Inc. (OTCBB: EMIS) announced study results in which twice-daily oral salmon calcitonin using Emisphere’s proprietary Eligen^® Drug Delivery Technology significantly suppressed markers of cartilage and bone degradation versus placebo in men and women with osteoarthritis, the most common form of arthritis. The study, a Phase I, placebo-controlled, double-blind, double-dummy, randomized, gender-stratified clinical trial, was conducted on behalf of Emisphere’s partner Novartis Pharma AG by Nordic Bioscience, and published online in the September 2009 issue of Osteoarthritis and Cartilage.

A total of 73 male and female subjects aged 57 to 75 years with painful osteoarthritis of the knee received twice-daily 0.6 mg or 0.8 mg doses of oral salmon calcitonin with the Eligen^® Technology or placebo administered over 14 days. Doses of 0.8mg compared with 0.6mg produced significantly higher C_max and AUC(0-4 hrs), of calcitonin,>Osteoarthritis and Cartilage; available online September 1, 2009).

“We are pleased that emerging data continue to indicate oral salmon calcitonin in combination with our absorption-enhancing Eligen^® Technology may be a potential therapeutic option for women and men with osteoarthritis, which affects more than 20 million people in the United States,” said Michael V. Novinski, President and Chief Executive Officer, Emisphere Technologies. “We look forward to further validating these results in the extensive ongoing Phase III clinical trial program.”

Emisphere announced in June 2009 that recruitment had been completed for the planned second multi-center Phase III study exploring the safety and efficacy of oral salmon calcitonin using the Eligen^® Technology to treat patients with osteoarthritis of the knee. Enrollment in the first Phase III trial for osteoarthritis was completed in September 2008.

Oral salmon calcitonin using Eligen^® Technology is also being investigated in a Phase III study for osteoporosis being conducted by Novartis Pharma AG and Nordic Bioscience.