Projects |
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Clinical Development Programm: |
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| axxonis currently
has three development products in advanced clinical stage in Parkinson’s
Disease (PD) and Restless Legs Syndrome (RLS). Lisuride TDS,
a transdermal formulation of Lisuride has been proven effective and safe
in larger Phase II/III trials for both PD and RLS. Lisuride TDS
in RLS is now being part of a pivotal Phase III program from which
headline data will become available during first half of 2007. Lisuride SubQ,
a formulation of Lisuride for the continuous subcutaneous delivery of the
drug by a mini pump, has also entered a pivotal Phase III clinical trial
to confirm the positive results of previous findings. Lisuride TDS - Parkinson is a Lisuride containing skin patch for the treatment of PD. The patch provides continuous dopaminergic stimulation through stable plasma concentrations that are stable for at least 48 hours. Efficacy was demonstrated in a placebo controlled double blind clinical study as adjunctive treatment to Levodopa in advanced PD patients: on-time significantly improved without increase in dyskinesia with significant improvement also in UPDRS II / III (daily life/motor examination) and all other endpoints. The effective dose was reached within 2 weeks with two 20 cm² patches applied every other evening. The patch was safe and well tolerated. Early dopaminergic adverse events (nausea, emesis, dizziness, orthostatism), severe adverse events (SAEs) and withdrawals due to systemic adverse events were all in the placebo range. Only local reversible mild skin reactions could be detected. The regulatory dossier is under preparation for submission in the EU. A second pivotal Phase III study with Lisuride TDS as mono therapy for early PD patients has achieved regulatory and ethical approval and has started beginning of 2007. In this three arm study, Lisuride TDS will be compared to active control (Pramipexole) and placebo on a double-dummy double-blind basis. Lisuride TDS – RLS is a Lisuride containing patch is similar to the patch to treat Parkinson’s disease but with a reduced patch size which is applied every other morning. This product will be indicated for the treatment of moderate to severe idiopathic and uremic Restless Legs Syndrome (RLS). Efficacy over placebo and dose dependency was demonstrated in a dose-finding clinical study with 210 patients. The treatment achieved a significant improvement in IRLS scores within 2-3 days of treatment and also significant improvement in “daytime tiredness”. In addition, a very low rate of peripheral side effects compared to those reported for oral dopamine agonist’s therapy was observed. A pivotal Phase III trial, comparing Lisuride TDS to placebo and Ropinirole as an active comparator has started first quarter 2006 and data of that trial will be available during first half of this year. Subsequent regulatory submission in EU is scheduled for second half of 2007. Lisuride SubQ - Late Stage Parkinson is a continuous subcutaneous infusion therapy delivery by a programmable mini pump. It is intended to treat late stage patients with severe fluctuations and will be an option for patients when standard combination therapy with levodopa and dopamine agonists proves no longer effective. Efficacy was demonstrated in a number of clinical studies (including a placebo controlled study) over the last two decades. Patients experienced a near-normal motor response without complicating dyskinesias and no development of tolerance could be detected during these studies. A pivotal Phase III clinical trial was initiated to confirm the positive results of previous clinical trials by other investigators. The application for registration was submitted to SwissMedic in Switzerland in 2005. Submission in EU is scheduled for second half of 2007. Preclinical Projects: In addition to its clinical development programs, axxonis has three preclinical programs and an undisclosed number of Drug Discovery projects: NBT-723 for the treatment of Traumatic Brain Injury (TBI), NBT-485 of for the treatment of Pulmonary Arterial Hypertension (PAH) and Idiopathic Pulmonary fibrosis (IPF); NBT-104/X, a proprietary dopamine agonist for which the final indication has not been selected yet. |
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