Results From Chelsea Therapeutics' Pivotal Northera (Droxidopa) Study to be Presented at the American Academy of Neurology's Annual Meeting

Update: Northera (droxidopa) Now FDA Approved for Neurogenic Orthostatic Hypotension - February 18, 2014

Symptomatic Benefits Seen in Patients With Neurogenic OH

CHARLOTTE, N.C., April 27, 2012 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today announced that Horacio Kaufmann, M.D., Professor of Medicine, NYU Langone Medical Center, New York, will present the full results from the previously reported Northera™ (droxidopa) Study 301 during the oral Clinical Trials Forum at the American Academy of Neurology 64th Annual Meeting in New Orleans, Louisiana, at 12:15 PM ET today. Overall, the results of the study showed droxidopa demonstrated statistical improvement compared to placebo in the trial for the primary clinical endpoint (OHQ composite score), which provides a comprehensive measure of symptoms for neurogenic orthostatic hypotension (known as Neurogenic OH or NOH). The results were consistent irrespective of gender, concomitant medications or primary diagnosis.

Droxidopa is currently under investigation for the treatment of symptomatic Neurogenic OH in patients with primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.

"Study 301 continues to be the only randomized, controlled trial to demonstrate improvement in the signs and symptoms of symptomatic Neurogenic OH," commented Dr. Kaufmann, a principal investigator in the study. "The overall data set shows that droxidopa demonstrated significant improvement over placebo in reducing symptoms of Neurogenic OH, including such cardinal features as dizziness, weakness and fatigue, in addition to increasing standing blood pressure."

"This analysis presented by Dr. Kaufmann continues to provide encouragement for patients with Parkinson's disease, multiple system atrophy and other autonomic disorders whose everyday lives are severely impaired by sudden drops in standing blood pressure," commented Dr. Simon Pedder, president and CEO of Chelsea Therapeutics. "The current treatment strategies for Neurogenic OH are limited and are not always effective for many patients. Chelsea Therapeutics remains dedicated to improving the lives of patients with symptomatic Neurogenic OH."

Results of Study 301

The mean change in Orthostatic Hypotension Questionnaire (OHQ) composite score showed a statistically significant improvement in patients taking droxidopa vs. those taking placebo (-1.83 ± 2.07 vs. -0.93 ± 1.69, respectively, P=0.003). Standing Systolic Blood Pressure (SBP) increased 11.2mmHg with droxidopa vs. 3.9mmHg with placebo (P < 0.001). Similar results were observed in Diastolic Blood Pressure (DBP) (increase of 2.1 mmHg).

Most adverse events (AEs) were mild to moderate in severity and were generally considered by investigators to be unlikely or not related to droxidopa. Supine hypertension (SBP > 180mmHg) reported as an AE occurred in 2 (2.5%) droxidopa-treated vs. 0 (0%) placebo-treated patients. The most frequent AEs in droxidopa-treated versus placebo-treated patients were headache 7.4% vs. 0%, dizziness 3.7% vs. 1.2%, nausea 2.5% vs. 0%, and falls 0% vs. 3.7%.

Study 301 was a double-blind, multi-center, randomized, placebo-controlled, parallel-group, induction-design study to assess effect on symptoms and their impact on activities of daily living in 263 patients with symptomatic Neurogenic OH. The primary endpoint was the mean change in the OHQ composite score, a patient-reported outcome measure that captures symptoms of Neurogenic OH and their impact on activities of daily living.

Presentation Details

Dr. Kaufmann's presentation, titled "Treatment of Neurogenic Orthostatic Hypotension (NOH) With Droxidopa: Results From A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Induction Design Study," will take place at 12:15 PM ET on Friday, April 27, 2012 at the Morial Convention Center in New Orleans.

About Northera™ (droxidopa)

Northera™ (droxidopa), the lead investigational agent in Chelsea Therapeutics' pipeline, has been studied in two Phase III clinical trials for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure -- a group of diseases that includes Parkinson's disease, multiple system atrophy (MSA) and pure autonomic failure (PAF). Droxidopa is a synthetic catecholamine that is directly converted to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE in the nervous system, both centrally and peripherally. The most common adverse event (greater than or equal to 5%) during placebo controlled trials was headache. Droxidopa is also being investigated for and completed Phase II trials in intradialytic hypotension and adult attention deficit hyperactivity disorder and fibromyalgia.

About Neurogenic Orthostatic Hypotension

Neurogenic OH is a chronic neurogenic disorder resulting from deficient release of norepinephrine, the neurotransmitter used by sympathetic autonomic nerves to send signals to the blood vessels and the heart to regulate blood pressure. This deficiency results in lightheadedness, dizziness, blurred vision, fatigue, poor concentration and fainting episodes when a person assumes a standing position. Symptoms of chronic Neurogenic OH can be incapacitating, not only putting patients at high risk for falls and associated injuries, but also severely affecting the ability to perform activities of daily living that require standing or walking.

About Chelsea Therapeutics

Chelsea Therapeutics (Nasdaq:CHTP) is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases, including central nervous system, rheumatoid arthritis, psoriasis and other inflammatory diseases. Founded in 2004 around its library of unique anti-inflammatory and autoimmune technology, Chelsea has further expanded its product development portfolio with early- and late-stage candidates that seek to leverage the company's development expertise and accelerate the company's drug commercialization efforts. For more information about the company, visit www.chelseatherapeutics.com.

This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include risk of FDA approval of Northera, risks and costs of drug development, our need to raise additional operating capital in the future, risk of regulatory approvals of our other drug candidates, our reliance on our lead drug candidates droxidopa and CH-4051, reliance on collaborations and licenses, intellectual property risks, our history of losses, competition, market acceptance for our products if any are approved for marketing, and reliance on key personnel including specifically Dr. Pedder.

CONTACT: Investors:

Kathryn McNeil

Chelsea Therapeutics

704-973-4231

mcneil@chelseatherapeutics.com

 

Media:

Lauren Tortorete

Hill+Knowlton Strategies

212-885-0348

lauren.tortorete@hillandknowlton.com

 

Posted: April 2012

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