Phase III Recharge Results on Maetro System expected in Feb
According to company press releases, conference calls, and my correspondence with investor relations, Phase III data from its Recharge study on its flagship product, The Maestro System, is due to be released around mid Q1. In 2009, traders bet the stock to near $30 a share on anticipation of the company's "EMPOWER" study succeeding.
"The ReCharge Study," requires the company show a 10% greater Excess Weight Loss (EWL) from randomization with the Maestro System after 12 months of VBLOC therapy compared to control by BMI method, and to observe clinically meaningful responder rates in the treatment arm of 20% and 25% EWL from implant at 12 months (not statistically based).
In 2010, the company's Australian cohort showed results that easily surpasses the new trial's requirements. 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 EWL 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); and
• No therapy-related serious adverse events or deaths were reported across the entire study population.
As we can see from above, the numbers easily surpass the endpoints defined in the new ReCharge Study. The statistical difference from the cohort study is 32% and with an even greater mean EWL, blowing away both Arena's (ARNA) and Vivus's (VVUS) anti-obesity drug treatments Belviq and Qsymia, respectively.
Considering all the factors here, I expect EnteroMedics to announce positive data sometime around the middle of February.
*exerted from Scott Matusaw on SA