Aderis Pharmaceuticals Announces Positive Final Analyses Of Rotigotine CDS Phase II Trial For Restless Legs Syndrome
Aderis Pharmaceuticals announced today that final analyses of data from a Phase II trial of rotigotine CDS (Constant Delivery System) in the treatment of Restless Legs Syndrome (RLS), conducted by Schwarz Pharma AG, indicate that the drug was well tolerated at all dose levels and induced a statistically significant reduction in symptoms. Results of the Phase II trial were presented by Schwarz Pharma at the 7th International Congress of Parkinson’s Disease and Movement Disorders. Rotigotine CDS, a once-a-day skin patch that delivers a novel dopamine agonist, is also being evaluated by Schwarz Pharma in Phase III trials for the treatment of Parkinson’s disease.The primary endpoint of the randomized, double-blind, placebo-controlled Phase II trial was a reduction in symptoms as measured by the International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale. Secondary endpoints included evaluations of symptoms at several times throughout the day and scores relating to symptoms such as sleep behavior, quality of sleep and daytime sleepiness. A total of 58 patients were evaluated according to the trial protocol, 12 of which received a placebo and 46 of which received rotigotine CDS at a dose of 1.125 mg, 2.250 mg or 4.5 mg. Treatment with rotigotine CDS resulted in a statistically significant, dose-dependent reduction of symptoms according to the primary endpoint. Additionally, the drug was well tolerated and there were no serious adverse events.
“The favorable clinical safety and efficacy profile of rotigotine CDS in this patient population reinforces positive results from previously conducted clinical trials of this drug in Parkinson’s disease,” said Peter Savas, Chairman, President and Chief Executive Officer of Aderis Pharmaceuticals. “Rotigotine is currently undergoing three Phase III trials in the US and Europe for treatment of Parkinson’s, and we believe that it has the potential to improve treatment both for the 4 million patients suffering from Parkinson’s as well as the 10% of the population suffering from RLS.”
Restless Legs Syndrome is a neurological disorder that often results in moderate to severe sleep deprivation. Characterized by a strong desire to move the legs in the evenings, during sleep or at other times of rest, it is estimated to affect up to 12 million Americans. There are currently no approved therapies that are specifically designed to treat RLS.
Rotigotine CDS is the first once-a-day skin patch to be evaluated for the treatment of Parkinson’s disease and Restless Legs Syndrome. The patch is designed to deliver a continuous stream of a novel dopamine agonist over a 24-hour period. This continuous transdermal delivery is intended to avoid the peaks and valleys inherent with oral dopamine agonists, which cause patients to experience side effects during the peaks and disease symptoms during the valleys.
During the conference’s Kickoff Seminar attended by more than 1000 people, Dr. Peter A. Lewitt, director of the Clinical Neuroscience Center in Southfield, Michigan, discussed the results of previous Phase II trials evaluating rotigotine CDS in the treatment of Parkinson’s disease. These trials were designed to determine if use of the rotigotine CDS patch allowed patients to achieve continuous dosing levels and bring patients greater symptom relief. In a randomized, double-blind, placebo-controlled Phase II trial of 316 patients with early-stage Parkinson’s disease, treatment with rotigotine CDS produced a clinically and statistically significant dose-dependent improvement in activities associated with daily living and motor scores as measured by the Unified Parkinson’s Disease Rating Scale II + III (UPDRS). Additionally, rotigotine CDS was well tolerated with a low incidence of adverse events.
Aderis Pharmaceuticals is a biopharmaceutical company engaged in small molecule drug development to treat central nervous system, cardiovascular and renal disorders. The Company currently has four product candidates for five indications in development, with one in Phase III clinical trials, three in Phase II clinical trials and one that is beginning a Phase IIa clinical trial. Aderis Pharmaceuticals has a strategic alliance with Schwarz Pharma, which develops rotigotine CDS, a dopamine agonist for the treatment of Parkinson’s disease using a proprietary continuous delivery transdermal patch. The Company also has alliances with Fujisawa Healthcare, Inc. and King Pharmaceuticals. Aderis Pharmaceuticals’ product pipeline includes receptor agonists and antagonists for the diagnosis and treatment of Parkinson’s disease, Restless Legs Syndrome, Atrial Fibrillation, coronary artery disease and wound healing in diabetic foot ulcers. Founded in 1994, Aderis Pharmaceuticals is headquartered in Hopkinton, Massachusetts and has research facilities in Richmond, Virginia.
Certain statements in this news release that are not historical fact constitute “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results of Aderis Pharmaceuticals to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors, such as regulatory approvals, collaboration agreements, competition and dependence on senior management, are discussed under the caption “Risk Factors” in Aderis Pharmaceuticals’ Form S-1 on file with the Securities and Exchange Commission.
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