Also from the detailed review, the company stated:
"Based on the analysis to date, the control arm of the trial, which was intended to be inactive, apparently provided a low-intensity blocking signal that introduced VBLOC Therapy in human subjects.
"Our interpretation of this statement is that the control arm somehow had VBLOC treatment as well which would explain the statistically indistinguishable results between both arms -- both groups lost weight."
President and CEO Mark Knudson stated:
"The apparent control arm effect, while unexpected, may be a scientifically important addition to our understanding of neuromodulation."
As we began to dig deeper into our due diligence, we found another pr dated November 8th, 2010 on the company's website that seems to back up my interpretation of the company's statements from the detailed November, 2009 report.
In the Australian cohort, a total of 83 subjects were enrolled at two centers, with 61 subjects implanted. Main outcome measures were morbidity, mortality and excess weight loss at 12 months. Results include:
•Mean 12-month excess weight loss was 25% for the treatment group and 17% for the control group;
•Weight loss was linearly related to hours of device use; subjects with greater than or equal to 9 hours/day use achieved 37% and 21% mean EWL (treated versus control, p = .02);
•No therapy-related serious adverse events or deaths were reported across the entire study population.
Based on the data above, it appears my understanding of the company's original suspicion was correct, the control arm of the EMPOWER study was receiving some form of treatment, when they should not have been.
The newly designed Recharge Study:
More often than not, drug companies, after realizing a failure in a late stage clinical study, meet with the FDA to determine the best path forward on how to re-design a study that is acceptable to the organization in order to gain eventual approval of a drug and/or a device. Also, more often than not, companies find success in a re-designed study.
In September 2009, ACADIA Pharmaceuticals Inc. drug Pimavanserin failed to meet its endpoints in the treatment of PSP on its initial Phase III study.
Uli Hacksell, Ph.D., Chief Executive Officer of ACADIA remarked at the time:
While we obviously are disappointed with the results of this Phase III study, we continue to believe in the potential of Pimavanserin based on our clinical experience to date. We will thoroughly analyze these data along with the data on other secondary and exploratory endpoints over the next month to better understand the outcome of this study. Meanwhile, we are continuing with the second Phase III PDP trial with Pimavanserin.
After engaging in a thorough analysis of the failed first Phase III trial for Pimavanserin, the company obviously got it right the second time around. On November 27, 2012, ACADIA announced successful top-line results from its pivotal Phase III trial.
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