Santhera Starts Phase IIb Clinical Trial with JP-1730 in Dyskinesia
in Parkinson's Disease
Santhera Pharmaceuticals (SWX:SANN), a Swiss specialty pharmaceutical
company focused on neuromuscular diseases, and Juvantia Pharma Ltd, a
Finnish biotechnology company, announced today 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.
Klaus Schollmeier, Santhera's CEO commenting on today's announcement
said: "This DPD trial is our largest study to-date. Importantly, DPD
is also the largest indication that Santhera is currently working on
in the clinic. Based on the encouraging proof of concept data from
Juvantia, we have now designed this trial to confirm the compound's
potential dual efficacy profile in a larger patient cohort. The data
obtained should provide final insight to complete the development of
this drug candidate in order to bring this important new product to
patients."
Keijo Väkiparta, Chairman of Juvantia, said: "Together, Santhera and
Juvantia have moved efficiently to initiate the Phase IIb trial with
JP-1730 in DPD as planned. The current clinical program in DPD
represents an excellent opportunity for Juvantia to drive the further
development of this important product."
In July 2006, Santhera and Juvantia signed a collaboration agreement
to advance the development of Juvantia's compound JP-1730 for the
treatment of patients suffering from DPD. Under the agreement,
Santhera is responsible for conducting and funding further
development work to generate data required for commencement of Phase
III trials. Santhera has a call option to secure all rights to the
product candidate via the acquisition of Juvantia at any time before
December 31, 2008 with a possible extension to June 30, 2009.
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.
About Dyskinesia in Parkinson's Disease
Parkinson's disease (PD) is the second most common neurodegenerative
disease. Its symptoms include uncontrollable tremor of the
extremities, rigidity of muscles and jerky movements, stooped
posture, expressionless face and difficulty in any function requiring
a high degree of motor coordination, such as walking, writing, and
talking. Current standard medical treatment for PD is based on
levodopa. Over time, as the disease progresses, the beneficial
effects of this therapy diminish and, for example, additional
movement disorders appear and become gradually very severe. As a
result, patients often require extended periods of hospitalization or
placement in a full-time nursing environment. In advanced disease
stages, movement disorders include dyskinesias (DPD) which can be
described as chaotic movements of limbs, face, tongue and the body,
typically during the peak on-time of the levodopa effect. These
complications derive principally from long-term levodopa use, but
there is no long-term solution to avoid using levodopa. It is
estimated that within 5 years of initiating levodopa treatment
approximately 20% of all PD patients develop troublesome dyskinesia
affecting their daily living.
About Fipamezole
Fipamezole is an antagonist of the adrenergic alpha-2 receptor and
offers a novel and unique mode of action to treat motor dysfunctions
in PD, such as dyskinesia (DPD). The rationale behind the development
of fipamezole is to increase noradrenergic release in certain areas
of the brain, resulting in a rebalancing of the distorted brain
network and alleviating symptoms of advanced PD such as dyskinesias,
motor fluctuations, orthostatic hypotension and cognitive impairment.
In addition, fipamezole is believed to extend the beneficial effects
of commonly used levodopa (prolonged on-time) and other dopamine
agonists without the negative side effects associated with these
treatments. Such therapy is expected to improve the quality of life
of Parkinson's patients.
* * *
About Santhera
Santhera Pharmaceuticals (SWX: SANN) is a Swiss specialty
pharmaceutical company focused on the discovery, development and
marketing of small-molecule pharmaceutical products for the treatment
of severe neuromuscular diseases. Santhera's vision is to become a
leading specialty pharmaceutical company offering therapies for a
number of indications in this area of high unmet medical need which
includes many orphan indications with no current therapy.
Santhera currently has five clinical-stage development programs,
three of which are investigating its lead compound, SNT-MC17 (INN:
idebenone), for the treatment of Friedreich's Ataxia (FRDA), Duchenne
Muscular Dystrophy (DMD) and Leber's Hereditary Optic Neuropathy
(LHON). Another clinical program is investigating JP-1730 (INN:
fipamezole) for the treatment of Dyskinesia in Parkinson's Disease
(DPD) in cooperation with Juvantia, the compound's owner. The fifth
program comprises SNT-317 (INN: omigapil) in Congenital Muscular
Dystrophies (CMD), a compound in-licensed from Novartis. The most
advanced program, SNT-MC17 in FRDA, is currently under review for
marketing approval in Europe and will be submitted shortly in Canada.
The compound is also in Phase III clinical development for FRDA in
the US while the other clinical programs are in Phase II. For further
information, please visit www.santhera.com.
For further information, contact
Klaus Schollmeier, Chief Executive Officer
Phone: +41 (0)61 906 89 52
klaus.schollmeier@santhera.com
Barbara Heller, Chief Financial Officer
Phone: +41 (0)61 906 89 54
barbara.heller@santhera.com
Thomas Staffelbach, VP Public & Investor Relations
Phone: +41 (0)61 906 89 47
thomas.staffelbach@santhera.com
Juvantia Pharma Ltd
Keijo Väkiparta, Chairman
Phone: +358 400 455 571
keijo.vakiparta@biofund.fi
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Santhera Pharmaceuticals Holding AG
Hammerstrasse 47 Liestal
Switzerland
WKN: A0LCUK; ISIN: CH0027148649; Index: SPI, SPIEX, SSCI;
Listed:
Main Market in SWX Swiss Exchange;
