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.
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