Elixir Pharmaceuticals says it has the clinical data to support an application for approval of its combination drug for Type 2 diabetes—expected, as earlier announced, to be submitted to the FDA next year—based on positive results from a late-stage clinical trial and previous studies, according to a company statement.
The Cambridge, MA-based biotech firm reports that patients in the Phase 3 study who took its pill that combines diabetes drugs metformin and mitiglinide had “statistically significant” greater reductions in blood sugar levels than those who were on metformin alone. Metformin improves insulin function throughout the day, while mitiglinide is intended to boost insulin production during rises in blood sugar after meals. The company says that it will not reveal full results from the trial—which included 350 patients at 60 U.S. sites—until an upcoming scientific meeting. And there’s no telling at this point how the FDA will judge the firm’s bid for approval of the combination drug (which it plans to market under the name Metgluna).
Nevertheless, the trial results are good news for Elixir, which pulled plans for an $86 million initial public offering this May due to the unsavory market for such financings. Biotechs in similar circumstances—like San Diego-based Phenomix—have seen progress in clinical trials for diabetes drugs pave the way to handsome partnerships with larger drugmakers. We’ll see where the results of this latest trial lead Elixir.