Oct 14 2009
BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today announced positive top-line results from its North American pivotal (Phase III) randomized controlled trial comparing its fully synthetic, off-the-shelf bone growth factor product, Augment Bone Graft (“Augment”), to autograft for use in hindfoot and ankle fusion surgery. The primary study goal was to establish non-inferiority of Augment compared to autograft. Autograft is the historical standard of care but has the limitation that it must be obtained and transplanted from another bone in the patient’s body, often requiring a second surgical procedure. These positive top-line results indicate that, with the use of Augment, patients can expect a comparable treatment outcome while being spared the pain and potential morbidity associated with traditional autograft bone harvesting and transplantation.
Study Results
For the primary endpoint, the percent of subjects achieving fusion as defined by 50% or greater bone bridging on CT scans at 24 weeks, patients treated with Augment experienced a similar fusion rate (61.2%) compared with those receiving autograft (62.0%), which met non-inferiority>
In the key clinical, secondary endpoints, the healing (union) rate was 83.1% for Augment compared to 83.9% for autograft at 24 weeks>
Seventy-five percent (75%) of patients in both groups had one or more risk factors for poor healing. There were no significant differences in the frequency of serious adverse events between the Augment and autograft treated patients. Finally, analysis of human anti-PDGF antibodies indicated only 13% of Augment patients experienced antibody formation at any time point, which dropped to 3.9% at six months. Additionally, 3.5% of autograft patients also had anti-PDGF antibodies. Most importantly, none of the antibodies in either group was neutralizing.
The data above reflect the results of the 397 patient “modified intent-to-treat” (mITT) study population. Thirty-seven (37) patients were excluded from this analysis, 21 of which were randomized but never treated and 16 which had major protocol deviations which were prospectively identified (e.g. midfoot fusions even though these were a specific exclusion criteria). Thus, the mITT population represents over 90% of all randomized patients and over 95% of all treated patients.
On a strict intent-to-treat (ITT) population in which those patients who were randomized but never treated are counted as automatic failures, 24 week fusion rates on CT scans were 57.9% for patients randomized to Augment and 60.4% for patients randomized to autograft>
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