deCODE genetics (Nasdaq:DCGN) today announced that it is voluntarily suspending
its Phase III clinical trial for DG031 (veliflapon), the company’s developmental
compound for the prevention of heart attack, in order to address an unexpected
formulation problem with the tablets being used in the trial. Routine testing
of clinical supplies has revealed that over time the tablets appear to dissolve
more slowly. Pharmacokinetic data indicates that to date this has not affected
drug exposure nor raised any safety concerns, but the company is concerned
that this change may eventually cause the tablets to release too little drug,
potentially limiting the effect of the compound and undermining the trial’s
chances of success. deCODE has presented the issue to the Food and Drug Administration
(FDA) and is exploring alternative manufacturing processes. A conference call
to discuss today’s announcement will be webcast live tomorrow, Friday, October
6, at 8:00am Eastern Time/12 noon GMT/1pm British Summer Time (details below).
“Faced with this problem, we felt that our only option was to put the trial
on hold and improve the formulation of the tablets. This is the right thing
to do both for patients and for the company, who have a common interest in
successfully developing drugs to prevent heart attack. We are leading the way
in targeting the leukotriene pathway to this end, and will continue our other
therapeutic and diagnostic programs in heart attack as we work to develop new
clinical supplies of DG031,” said Kari Stefansson, CEO of deCODE.
deCODE’s programs in heart attack
Through its population genetics work, deCODE has linked variants in two genes
to significantly increased risk of heart attack. Both genes encode proteins
in the leukotriene pathway, and the variants appear to confer increased risk
of heart attack by increasing the production of a potent driver of inflammation:
leukotriene B4 (LTB4). DG031 and DG051, the company’s other developmental
compound for the prevention of heart attack which is now in Phase I clinical
testing, are aimed at lowering risk of heart attack by inhibiting the activity
of this pathway and reducing LTB4 production. deCODE is also using its discoveries
to develop diagnostic tests to gauge individual risk of heart attack.
About deCODE
deCODE genetics (Nasdaq:DCGN) is a global leader in applying human genetics
to develop drugs for common diseases. Our population approach has enabled
us to discover and target key biological pathways involved in conditions
ranging from heart attack to cancer. We are turning these discoveries into
new medicine to better treat and prevent many of the biggest challenges to
public health. deCODE is delivering on the promise of the new genetics.SM
Visit us on the web at www.decode.com.
Conference Call Information
A conference call, in which deCODE management will discuss today’s announcement
will be webcast live tomorrow, Friday October 6, at 8:00am EDT/12 noon GMT/1pm
British Summer Time. The webcast can be accessed via the Investors
section of deCODE’s website, www.decode.com. A replay of the call will be available
on this site for at least one week following the call. A digitized telephone
replay of the call can be accessed for the week following the call by dialing
1 800 475 6701 from the US, or +1 320 365 3844 from outside the US. The access
code is 844516.
Any statements contained in this presentation that relate to future plans,
events or performance are forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. These forward-looking
statements are subject to a number of risks and uncertainties that could cause
actual results to differ materially from those described in the forward-looking
statements. These risks and uncertainties include, among others, those relating
to technology and product development, integration of acquired businesses,
market acceptance, government regulation and regulatory approval processes,
intellectual property rights and litigation, dependence on collaborative relationships,
ability to obtain financing, competitive products, industry trends and other
risks identified in deCODE’s filings with the Securities and Exchange Commission.
deCODE undertakes no obligation to update or alter these forward-looking statements
as a result of new information, future events or otherwise.
