BMTI Study Shows Non-Inferiority for Augment Bone Graft
BY LAUREN UZDIENSKI, OCTOBER 14, 2009
Yesterday BioMimetic Therapeutics released positive results from its North American pivotal study of Augment bone graft, the company's fully-synthetic, PDGF-derived PMA candidate. On a modified intent-to-treat basis, Augment achieved its primary endpoint of non-inferiority to autograft in attaining foot and ankle fusions.
The randomized controlled trial enrolled 434 patients at 37 sites in the U.S. and Canada. 75% of subjects in both groups had risk factors for poor healing, including diabetes, smoking and obesity. The modified intent-to-treat analysis showed that at 24 weeks, Augment patients experienced a 61% fusion rate, compared 62% fusion rate for the autograft group, which is statistically non-inferior. Fusion was defined as 50% or greater bone bridging on a CT scan. The study showed similar healing rates in both groups.
On an intent-to-treat basis, Augment did not achieve non-inferiority to autograft. However, the intent-to-treat analysis includes 37 automatic failures, including cases where patients were randomized but never had the surgery, or cases with substantial deviations from protocol (e.g., surgeon performed a midfoot fusion). It is expected that the FDA will accept the modified analysis that excludes those cases.
Back in June, the company submitted to the FDA the first two of three PMA modules, the pre-clinical pharmacology/toxicology and quality/manufacturing modules. They plan to submit the third module, which will consist of the clinical data, before the end of the year. If approved, the product will fill an unmet clinical need for an alternative to autograft, which is associated with donor-site infection, morbidity and pain. Additionally, the product would join other recombinant products currently on the market, such as BMP-2 (InFuse) for spine and certain dental indications, and Stryker's OP-1, which has an HDE designation.
