Phase III results with SBG for diabetic foot ulcer not positive
Published 23.11.2009
Biotec Pharmacon has received the results from both its phase III studies with SBG for diabetic foot ulcer and regrets to inform that the results are not positive. The studies failed to show superiority of SBG vs. placebo in terms of ulcer healing, and the company will thus not proceed with the further activities planned for this indication.
“The completion of these phase III studies was a major milestone for Biotec Pharmacon, and the results are a disappointing setback for everybody involved, internally as well as externally,” says CEO Lars Viksmoen in Biotec Pharmacon.
Overall, the results from both studies are very consistent. Both groups received the best available general wound care, and on top of that either SBG or placebo. The primary endpoint of the phase III diabetic ulcer program was the percentage of target ulcers healed after eight weeks, which was at a 30 percent level in both treatment groups. No harmful effects to patients were reported.
From a study design point of view, selecting another primary endpoint would not have resulted in a different outcome. Furthermore, response rates were similar between different clinical centres and countries. Samples are being collected for analysis of biological activity to exclude that SBG was exposed to any unexpected harm.
Blinded interim analyses for both studies had already provided advice not to increase the size of the patient populations. The company has stressed that this merely outlined the following possible study outcomes; (i) that the treatment response from the two patient groups were trending towards demonstrating a significant difference between the two treatment groups, in either direction, or, (ii) that the difference was so small that not even a large increase in the size of the patient population would be expected to yield a statistically significant difference. As described above, the latter turned out to be the case.
“We have been very careful not to take a positive outcome for granted but are obviously very disappointed to see that results received in earlier clinical stages were not confirmed in phase III. This is unfortunate, although not unique in the pharmaceutical industry,” says Viksmoen.
“We proceed with our ongoing phase III study with SBG for oral mucositis, where the results are expected in the first quarter next year. The Board and management will carefully consider the options for the further development of the SBG portfolio”, says Viksmoen. Although the oral mucositis study is a completely different study, it is still part of the company’s ulcers and wound franchise, and Biotec Pharmacon’s expectations for these results have been lowered due to the outcome of the diabetic foot ulcer studies.
Biotec Pharmacon also has a clinical program with SBG in immunotherapy of cancer, where pre-clinical and early stage clinical data indicate a synergistic effect between SBG and monoclonal antibodies. The company has also done pre-clinical research with interesting results looking into other indications for SBG. Furthermore, Biotec Marine Biochemicals, a fully owned subsidiary of Biotec Pharmacon, has a profitable and fast growing business with cold adapted enzymes targeting the molecular biology market.
Overall, the results from both studies are very consistent. Both groups received the best available general wound care, and on top of that either SBG or placebo. The primary endpoint of the phase III diabetic ulcer program was the percentage of target ulcers healed after eight weeks, which was at a 30 percent level in both treatment groups. No harmful effects to patients were reported.
From a study design point of view, selecting another primary endpoint would not have resulted in a different outcome. Furthermore, response rates were similar between different clinical centres and countries. Samples are being collected for analysis of biological activity to exclude that SBG was exposed to any unexpected harm.
Blinded interim analyses for both studies had already provided advice not to increase the size of the patient populations. The company has stressed that this merely outlined the following possible study outcomes; (i) that the treatment response from the two patient groups were trending towards demonstrating a significant difference between the two treatment groups, in either direction, or, (ii) that the difference was so small that not even a large increase in the size of the patient population would be expected to yield a statistically significant difference. As described above, the latter turned out to be the case.
“We have been very careful not to take a positive outcome for granted but are obviously very disappointed to see that results received in earlier clinical stages were not confirmed in phase III. This is unfortunate, although not unique in the pharmaceutical industry,” says Viksmoen.
“We proceed with our ongoing phase III study with SBG for oral mucositis, where the results are expected in the first quarter next year. The Board and management will carefully consider the options for the further development of the SBG portfolio”, says Viksmoen. Although the oral mucositis study is a completely different study, it is still part of the company’s ulcers and wound franchise, and Biotec Pharmacon’s expectations for these results have been lowered due to the outcome of the diabetic foot ulcer studies.
Biotec Pharmacon also has a clinical program with SBG in immunotherapy of cancer, where pre-clinical and early stage clinical data indicate a synergistic effect between SBG and monoclonal antibodies. The company has also done pre-clinical research with interesting results looking into other indications for SBG. Furthermore, Biotec Marine Biochemicals, a fully owned subsidiary of Biotec Pharmacon, has a profitable and fast growing business with cold adapted enzymes targeting the molecular biology market.
