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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.
Lisuride: General information
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
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.
Aspects on the Quality of Lisuride TDS
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