Histogenics’ Phase III clinical trial of NeoCart® tissue engineered implant did not meet the primary endpoint of a statistically significant improvement in pain and function vs. microfracture in a dual threshold responder analysis at one year. In the modified Intent to Treat (mITT) population (which excludes patients who were randomized but not treated with NeoCart), 74% of NeoCart patients exhibited clinically meaningful improvements in pain and function vs. 62% of microfracture patients. However, in this mITT population, patients treated with NeoCart achieved a statistically significant improvement in pain and function at six months vs. microfracture.
Analysis of the data has yielded important observations, such as a statistically significant improvement of NeoCart vs. microfracture in lesion sizes of greater than 2cm and patients with higher body mass index. Data from this trial are also consistent with results seen in prior clinical trials of NeoCart, as well as the biomechanical data generated as part of a collaboration with Cornell University.
The company will continue to pursue a Biologics License Application with FDA.
The Phase III trial is believed to be the largest and first prospectively designed, randomized clinical trial in North America to evaluate safety and efficacy of a restorative cell therapy to treat knee cartilage damage. Further, it is also believed to be the only trial with a dual threshold responder analysis endpoint.
Histogenics' Phase III clinical trial of NeoCart® tissue engineered implant did not meet the primary endpoint of a statistically significant improvement in pain and function vs. microfracture in a dual threshold responder analysis at one year. In the modified Intent to Treat (mITT) population (which excludes patients who were randomized but not...
Histogenics’ Phase III clinical trial of NeoCart® tissue engineered implant did not meet the primary endpoint of a statistically significant improvement in pain and function vs. microfracture in a dual threshold responder analysis at one year. In the modified Intent to Treat (mITT) population (which excludes patients who were randomized but not treated with NeoCart), 74% of NeoCart patients exhibited clinically meaningful improvements in pain and function vs. 62% of microfracture patients. However, in this mITT population, patients treated with NeoCart achieved a statistically significant improvement in pain and function at six months vs. microfracture.
Analysis of the data has yielded important observations, such as a statistically significant improvement of NeoCart vs. microfracture in lesion sizes of greater than 2cm and patients with higher body mass index. Data from this trial are also consistent with results seen in prior clinical trials of NeoCart, as well as the biomechanical data generated as part of a collaboration with Cornell University.
The company will continue to pursue a Biologics License Application with FDA.
The Phase III trial is believed to be the largest and first prospectively designed, randomized clinical trial in North America to evaluate safety and efficacy of a restorative cell therapy to treat knee cartilage damage. Further, it is also believed to be the only trial with a dual threshold responder analysis endpoint.
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