Diamyd initiates closure of US Phase III study
Diamyd Medical AB reports that the Company has decided to suspend dosing
in a US Phase III study with the antigen-based therapy Diamyd® and to
initiate closure of the study.
Following consultation with the US Food and Drug Administration (FDA),
Diamyd Medical has decided to suspend dosing in its US Phase III study,
DiaPrevent, with the antigen-based therapy Diamyd®. Study closure
activities will commence promptly. The decision follows a blinded review
of the efficacy data collected to date in the study as well as the
previously reported negative outcome of a European Phase III study of
the same design.
“It is sad to report that we are terminating the current Phase III
program with Diamyd®,” says Peter Zerhouni, Acting President and CEO of
Diamyd Medical. “Our review of the available data suggests the
DiaPrevent study is not likely to reach a positive outcome regarding
efficacy and therefore it cannot be justified to complete the study as
originally planned. However, the safety profile remains good. We want to
express our sincere gratitude to all the study participants, as well as
their families and the many doctors and nurses in the study.”
The Phase III study conducted in the US, called DiaPrevent, has 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
were scheduled to receive four subcutaneous injections of Diamyd®;
one-third to receive two injections of Diamyd®; and one-third to receive
placebo (non-active substance). The injections were to be given over a
period of 9 months. The last patient randomized into the study received
the first injection of Diamyd® or placebo in December 2010. The study
included a main study period of 15 months, but this will now be
shortened.
On May 9, 2011, the Company reported that its parallel European Phase
III study with 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. The follow-up period of the European Phase III
study was closed on June 1, 2011. Detailed results from the European
study will be presented at the American Diabetes Association's 71st
Scientific Sessions (ADA) in San Diego, CA, USA, on June 28, 2011.
The research consortium Type 1 Diabetes TrialNet is conducting a Phase
II trial with Diamyd® in the US and Canada with a similar study design.
Results from that study will also be presented at the ADA in San Diego,
on June 27, 2011.
An externally funded and researcher-initiated Phase II study with
Diamyd® aiming to prevent type 1 diabetes in children at high risk of
developing the disease is in progress. That study is not affected by the
findings in the two Phase III trials.
“We remain hopeful that Diamyd® and the active substance GAD65 can be
effective if administered earlier in the disease process to prevent type
1 diabetes, in certain subgroups, in combination with other drugs or in
a different treatment regimen,” says Peter Zerhouni. “Immunological data
collected in our European Phase III study has yet to be reviewed and
will guide us in setting the future plan for Diamyd® and GAD65.”
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
