Novo Nordisk/Aradigm Inhaled Insulin Study For Type 1 Diabetes Raises Efficacy Concern
This article was originally published in The Pink Sheet Daily
Executive Summary
Clinical focus could shift solely to type 2 diabetes. Interim analysis shows unexpected delay in post-meal glucose suppression, but Novo and Aradigm say positive safety results make data “very usable in our regulatory filing.”
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Novo Nordisk/Aradigm's clinical focus for its AERx iDMS inhaled insulin system may shift to type 2 diabetes only, following disappointing glucose suppression results in a Phase III trial for type 1 diabetes. "It's very, very possible that we'll be focusing the iDMS program on type 2 going forward….That needs to be part of our final analysis, but that is a very possible outcome," Aradigm CEO Richard Thompson told investors April 30. "Type 1 patients…have a much tighter requirement for the insulin profile, and the profile that we're seeing here may not meet the needs of those patients. So while we may not be able to address the smaller portion of this market, our Phase III safety data and our HbA1c data would indicate that we have a pretty good chance at working with the type 2 patients very effectively." An interim analysis of the Phase III study showed an unexpected delay in post-meal plasma glucose suppression. As a result, Novo will amend the trial protocol to 19 months instead of the planned 24 months. Despite the revision, "the [safety] data is excellent and we expect that it will be very usable in our regulatory filing," Thompson said, noting that no neutralizing antibodies were seen in the analysis. "There was no safety issue at all in the decision here." "In the original design of this study, the FDA asked us to focus our attention on type 1 because they are the more difficult patient population to control, but this type 1 study was intended to be the primary long-term safety study for both sets of patients…so we see this data as still being very useful even for the type 2 population." The exec acknowledged that "part of the evaluation going forward" will be whether a 24-month trial in type 2 patients will be necessary. "No doubt, there needs to be 24 months of data somewhere in our program." Thompson declined to speculate on when the PK analysis will be complete and when the Phase III program will resume, but said "there's a pretty good chance that we'll have that all figured out in the next couple months." The safety profile of the investigational inhaled insulins is likely to be a review issue. The NDA filing for Pfizer/Aventis' Exubera , the first inhaled insulin to reach Phase III, has been delayed since 2001 due to pulmonary safety issues. The firms announced a European filing March 4 (1 (Also see "Pfizer/Aventis File For Exubera In Europe; No Timeline Yet On U.S. Submission" - Pink Sheet, 4 Mar, 2004.)). - Lee Szilagyi |