Diamyd closes European Phase III study
Diamyd Medical AB reports that the Company has decided not to complete
the follow-up period of a European Phase III study with the
antigen-based therapy Diamyd®.
On May 9, the Company reported that its European Phase III study with
the antigen based therapy Diamyd® did not meet the primary efficacy
endpoint of preserving beta cell function at 15 months, as measured by
meal stimulated C-peptide, although a small positive effect was seen.
Furthermore, Diamyd® was well tolerated as demonstrated by a similar
number of adverse events in the Diamyd® treated groups as well as in the
placebo treated group.
As part of a planned, longer-term follow-up, patients in the study were
being followed for an additional 15 months, aiming to determine the
durability of the treatment effect at 30 months. Following comprehensive
evaluation of the collected study data, Diamyd Medical has decided not
to complete the follow-up period.
“Given that the European Phase III study did not meet the primary
efficacy endpoint, it is difficult to justify continuing the follow-up
period, although the results suggest beneficial effects in certain
subgroups,” says Peter Zerhouni, Acting President and CEO of Diamyd
Medical. “We would, once again, like to express our sincere gratitude to
all the study participants, as well as their families and the many
doctors and nurses who made the study possible. Our parallel US Phase
III study, DiaPrevent, continues and we hope it will result in a
different outcome.”
The European Phase III study enrolled more than 320 patients between 10
and 20 years of age who were diagnosed with type 1 diabetes within three
months of entering the study. The study includes three treatment arms in
which one-third of the patients received four subcutaneous injections of
Diamyd®; one-third received two injections of Diamyd®; and one-third
received placebo (non-active substance). The patients have been followed
for at least 6 months after receiving the last injection of Diamyd® or
placebo, fulfilling the main study period of 15 months and the study
drug was well tolerated. Detailed results from the study will be
presented at the American Diabetes Association's 71st Scientific
Sessions in San Diego, CA, USA, June 24-28, 2011.
An ongoing parallel US Phase III study, DiaPrevent, was fully enrolled
in December 2010, and results are expected in the summer of 2012. In
addition, the research consortium Type 1 diabetes TrialNet is conducting
a Phase II trial with Diamyd® in the US and Canada with similar design.
Another externally funded and researcher-initiated Phase II study with
Diamyd® in progress is aiming to prevent type 1 diabetes from developing
in high risk subjects.
For more information, please contact:
Peter Zerhouni, Acting President and CEO Diamyd Medical AB (publ.)
Phone: +46 8 661 0026
For press material, please contact:
Andreas Ericsson, Diamyd Medical AB (publ.)
press@diamyd.com (press@diamyd.com)
Phone: +46 8 661 0026
