Piper: DCGN :Follow up from DG031 Results Conference Call
October 19, 2004
* deCODE genetics just completed a conference call discussing positive Phase IIa data on DG031 released this morning.
* The study enrolled 191 elderly patients with the FLAP haplotype and prior heart attack with 172 patients completing the study. Patients were dosed with 250mg of placebo or DG031 in three dosing cohorts of once, twice, or three times daily for four weeks. Following dosing and a two-week washout period, the drug and placebo groups were switched and dosed for another four weeks.
* As expected, DG031 was found to be safe and well tolerated with no serious adverse events related to the drug including liver toxicity. There were two deaths in the trial; one MI in a treated patient and one in a placebo arm who was never treated.
* Importantly, DG031 demonstrated a dose-dependent reduction in CV inflammatory biomarkers including leukotriene b4 (LB4), myeloperoxidase and sICAM-I. These validated biomarkers have been linked to an increased risk in heart attack.
* Next, deCODE is schedule to meet with the FDA in early November to discuss the future development plan for DG031. deCODE remains intent upon advancing the drug directly into Phase III trials early next year.
* This summer, management discussed the potential design of the information-rich, randomized, placebo-control Phase III trial stating it would enroll at least 1,500 patients powered at 80% to see a 30% reduction in CVD events. deCODE speculated such a trial would last ~18 months and result in a minimum of 150 events.
* We continue to believe that deCODE intends to partner DG031 potentially next year. We believe deCODE could recognize a significant return on DG031, which was in-licensed from Bayer only 12 months ago for a few million dollars. |
