Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) went down by 18.45% to $5.04 after it announced its plans to modify Study 306, a Phase III study of NORTHERA in symptomatic neurogenic orthostatic hypotension associated with Parkinson's disease.
The Stock opened at $5.00 and traded in the range of $4.75-$5.73 with high volume of 5.13 million shares compared to the daily average volume of 449,065 shares. The market capitalization of the stock stands at $247.59 million with beta of 1.68. The stock has 52 week range of $1.94-$8.20.
A Data Monitoring Committee (DSMB) concluded that continuation of Study 306 with Orthostatic Hypotension Questionnaire (OHQ) Composite as the primary endpoint would be futile. The Company also announced that the trial met a key secondary endpoint, demonstrating a meaningful difference in fall rates between Droxidopa and placebo arms.
The Company will continue the trial as Study 306b, with falls as the new primary endpoint. Management plans to launch Droxidopa in second quarter of 2012.
Study 306 was powered to detect a 1.4 point difference on the OHQ scale. In an interim efficacy analysis of the first 51 patients, an unexpected high placebo effect resulted in a minimal treatment benefit on OHQ (0.2 units placebo-adjusted) after 8-10 weeks treatment. The mean improvement in OHQ composite score was 2.3 points versus 2.1 in the placebo arm. A 57% reduction in falls was observed: 0.93 versus 0.40 falls/patient/week.
Study 306b will enroll a total of 162 patients and is expected to generate top-line results in second quarter of 2012. Management plans to submit data from Study 306b as an sNDA in second half of 2011 to support label expansion to falls.
Chelsea Therapeutics International, Ltd. is a development stage pharmaceutical company that focuses on acquiring, developing and commercializing products for the treatment of a variety of human diseases.
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