Santhera Starts Phase IIb Clinical Trial with JP-1730 in Dyskinesia in Parkinson's Disease

12-Nov-2007

Santhera Pharmaceuticals and Juvantia Pharma Ltd announced that the first patient has been enrolled into a Phase IIb clinical trial to evaluate JP-1730 (INN: fipamezole) for the treatment of dyskinesia in Parkinson's disease (DPD). The study is designed to confirm the dual efficacy of the compound observed previously in a successful proof-of-concept trial. The Phase IIb trial, named FJORD, specifically investigates JP-1730's capacity to reduce dyskinetic movements and to extend the anti-parkinsonian action of levodopa Results are expected in the second half of 2008.

The Phase IIb trial named FJORD (Fipamezole from Juvantia fOR treatment of Dyskinesia) evaluates JP-1730 in DPD, using a double-blind, randomized, placebo-controlled dose response design involving 152 patients. The safety and efficacy of three escalating doses of JP-1730 (30, 60 and 90 mg tid using a newly developed fast dissolving tablet) will be compared to placebo over a treatment period of 28 days. The primary endpoint is the reduction of dyskinetic movements in PD patients as assessed by the newly developed "levodopa-induced dyskinesia scale" (LIDS) for rating DPD. Secondary endpoint is the efficacy of the three doses in extending levodopa anti-parkinsonian action, being assessed using an electronic patient diary. The clinical trial will evaluate additional benefits of JP-1730, such as the impact on cognitive functions measured by a neuropsychological testing battery.

The FJORD study will enroll patients with advanced PD and will be conducted at 30 sites in the US and India. Results of the trial are expected in the second half of 2008. The study design, dose selection and duration of the treatment period have been based on the positive results obtained in an earlier Phase IIa proof-of-concept trial in collaboration between Juvantia and the US National Institutes of Health in a smaller patient population. The goal of the FJORD study is to provide data on efficacy and safety of JP-1730 as well as information on feasible endpoints for the planning and execution of a subsequent Phase III development of the compound in DPD in the US and EU.

The US Food and Drug Administration (FDA) has granted Juvantia a fast track designation for the compound for the treatment of dyskinesia in advanced PD. In the EU, patent protection was recently granted for the novel formulation of JP-1730 until 2023.

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