Chelsea Therapeutics Study Shows Symptomatic Benefits

September 25, 2009 (FinancialWire) — Chelsea Therapeutics International, Ltd. (NASDAQ: CHTP) announced top-line results from Study 302, the first of two Phase III trials of Droxidopa for the treatment of symptomatic neurogenic orthostatic hypotension.

While Study 302 demonstrated that Droxidopa showed a strong symptomatic benefit during the open-label dose titration and run-in phase of the trial, a preliminary review of the data indicates it did not demonstrate a statistically significant improvement relative to placebo, as measured by the mean score of Item 1 (dizziness or light-headedness) of the Orthostatic Hypotension Symptom Assessment  during the double-blind phase of trial, the study’s primary endpoint. Droxidopa was safe and well tolerated, with no significant related adverse events reported.

“While the outcome on Item 1 of the OHSA scale did not meet the company’s expectations, our preliminary look at each of the secondary symptomatic outcome measures was encouraging and supportive of the therapeutic benefit of Droxidopa in neurogenic orthostatic hypotension,” commented Dr. Simon Pedder, Chelsea’s president and CEO. “Further, we anticipate a more comprehensive review of the data will help determine the relative impact of a higher than anticipated placebo response and what, if any, additional factors may have contributed to these unexpected results. Key features to the design of this study included an initial 7-day open-label drug treatment period following dose titration and prior to a 14-day randomized withdrawal treatment period. While we intended to stabilize patients immediately prior to withdrawal, the observed decline in BP during this period appears to have had a negative effect on the study’s ability to discern treatment effect. In addition, the benefits of Droxidopa, as measured by both BP and item 1 of the OHSA scale, appeared to persist to some extent despite absence of therapy, raising potential questions regarding the suitability of this type of trial design for an NOH study. We remain hopeful that the results of Study 301, which is a standard induction design study in which patients are washed out between titration and the blinded study, may provide a better opportunity to clearly demonstrate the efficacy of Droxidopa in this indication.”

Study 302 was an enriched, double-blind, placebo controlled withdrawal-design study in which all patients underwent an initial open-label dose titration. Patients demonstrating both a symptomatic benefit and blood pressure improvement following titration continued on open-label Droxidopa for a 1-week run-in period prior to being randomized on a 1: 1 basis to continue on active drug or be withdrawn to placebo. The 101 patients enrolled in the blinded study had a mean score on Item 1 of the OHSA scale of 2.1 at randomization. At the end of the 14-day blinded treatment period, patients in the placebo arm had an average OHSA score of 4.0, or a mean change (increase) of 1.9 units from randomization. Patients in the Droxidopa arm of the trial had a mean score of 3.5 at the end of the two week treatment period, reflecting a mean change from randomization of 1.3 units resulting in a 0.6 unit difference (p=0.51) between arms.

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