NicOx Announces Second Naproxcinod Pivotal Phase 3 Study (302) Meets Efficacy Primary Endpoints and Supports Non-Detrimental Blood Pressure Effect
NicOx' phase 3 clinical program for naproxcinod consists of three pivotaltrials (including the previously completed 301 study in osteoarthritis of theknee and the ongoing 303 study in osteoarthritis of the hip, in addition tothe 302 study). Overall, the results of the 302 study support naproxcinod'snon-detrimental effect on blood pressure and are consistent with thoseobserved in the 301 study, with naproxcinod 750 mg bid showing a numericalreduction in systolic and diastolic blood pressure at week-13 and 26,compared to baseline and naproxen 500 mg bid. Existing non-steroidalanti-inflammatory agents (NSAIDs) such as ibuprofen and naproxen have thetendency to raise blood pressure, which is a side effect of particularconcern in the osteoarthritis population.
A post hoc pooled analysis of the blood pressure data from the 301 and302 studies showed a statistically significant reduction for naproxcinod 750mg bid, compared to naproxen 500 mg bid, in terms of the mean change frombaseline at week-13, of 2.3 mmHg (p=0.004) for systolic blood pressure and1.1 mmHg (p=0.034) for diastolic blood pressure. In the planning of the phase3 program, NicOx had foreseen the pooling of office blood pressuremeasurements (OBPMs) from more than one study in order to obtain thenecessary statistical power to correctly assess the effects of naproxcinod onblood pressure, compared to naproxen. A pre-specified analysis of the pooledblood pressure data from the three phase 3 studies will be conductedfollowing the completion of the third phase 3 trial (the 303 study) in thefourth quarter of 2008.
Michele Garufi, Chairman and CEO of NicOx, commented: "We are impressedby the strong efficacy results observed in this study, which have replicatedthe positive results of the 301 trial and clearly demonstratednon-inferiority to naproxen at 26 weeks. The results of these two pivotalstudies give us increasing confidence that naproxcinod will meet regulatoryrequirements for approval in the United States and Europe. Moreover, based onthe results of the pooled analysis on blood pressure from these studies, wefirmly believe that naproxcinod has the potential to fulfill the currentmedical need for an efficacious anti-inflammatory agent with no detrimentalimpact on blood pressure."
Positive efficacy results in comparison to placebo and naproxen
As in the 301 study, both naproxcinod doses (375 mg bid and 750 mg bid)were shown to be superior to placebo on the three co-primary efficacyendpoints of the 302 trial, the WOMAC(TM) pain subscale, the WOMAC(TM)function subscale and patients' overall rating of disease status, with thesebeing highly statistically significant (p<0.001) in terms of the mean changefrom baseline at week-13. Superiority comparisons versus placebo on thesethree co-primary endpoints in two well designed, well controlled trialsconform to U.S. Food and Drug Administration (FDA) guidance for demonstratingthe efficacy of new drugs for the treatment of the signs and symptoms ofosteoarthritis.
The main secondary endpoint of the trial assessed the efficacy ofnaproxcinod 750 mg bid to naproxen 500 mg bid at
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