Biotec Pharmacon: Phase III results with SBG for diabetic foot ulcer not positive
"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.
Most read news
Organizations
Other news from the department research and development
Get the life science industry in your inbox
From now on, don't miss a thing: Our newsletter for biotechnology, pharma and life sciences brings you up to date every Tuesday and Thursday. The latest industry news, product highlights and innovations - compact and easy to understand in your inbox. Researched by us so you don't have to.