Biotie announces topline data from an exploratory phase 2a study with SYN118 in Parkinson's disease
Biotie Therapies Corp., a development stage company focused on diseases of the central nervous system, today announced results from an exploratory phase 2a study of its HPPD inhibitor SYN118 in Parkinson's disease (PD). These data do not show a significant improvement in measures of PD motor function when compared to placebo. Biotie will consider development options for the compound and will announce further plans later in the year.
SYN118 is subject to an option agreement with UCB as part of a broader partnership. Biotie does not expect UCB to exercise its option to license the compound based on the now published data. The UCB collaboration also includes Biotie's novel adenosine A2a receptor antagonist, SYN115, which is in phase 2b development for PD targeting a mechanism of action different from that of SYN 118 and which has been shown to significantly modulate the off-time (time when Parkinson's patients have rigidity and other associated problems) without an increase in dyskinesias.
"We are disappointed that this novel approach to treating Parkinson's patients at an advanced stage of the disease, where levodopa is no longer controlling symptoms, was not successful. However, today's results have no impact on the development of our lead PD product, SYN115, and our agreement with UCB around it. There remains a need for new medicines to treat PD that work through mechanisms different to those of existing drugs, and we remain committed to their development" said Timo Veromaa, President and CEO of Biotie Therapies.
In Turku, 24 May, 2011
Biotie Therapies Corp.
Timo Veromaa President and CEO
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About the Phase 2a study in Parkinson's disease
In this exploratory study conducted in France and the Czech Republic, 127 levodopa-treated PD patients with wearing-off motor fluctuations were randomized to receive either SYN118 or placebo added on their existing anti-Parkinson medications for 8 weeks. The drug was well tolerated but there was no appreciable difference between SYN118 and placebo in the outcomes of highest interest in this study which were: UPDRS part III (motor function) before and approximately 2 hours after the patients' usual anti-Parkinson medication i.e. when in the "off" and "on" states respectively and in daily time in "off" and in "on" as recorded by the patients using home diaries.
SYN118 is a potent and selective inhibitor of 4-hydroxyphenylpyruvate dioxygenase (HPPD). HPPD is an enzyme in the primary pathway responsible for the breakdown of tyrosine, the precursor of the neurotransmitter dopamine. This novel point of intervention has been thought to offer the potential to induce a sustained increase in dopamine synthesis in specific regions of the brain resulting in clinical benefit.
SYN118 was discovered by AstraZeneca and developed by Syngenta and their partner Swedish Orphan for the treatment of hereditary tyrosinemia type 1. In 2007, Biotie (formerly Synosia) obtained rights from Syngenta to develop and commercialize SYN118 in non-orphan diseases.
Swedish Orphan International (SOI) markets the compound in Europe, the United States, Australia and Russia for the treatment of hereditary tyrosinemia type 1, under the brand name Orfadin®. The development program of SOI has generated over 5,000 patient years of clinical and market experience to date.
Biotie is a specialized drug development company focused on the development of drugs for neurodegenerative and psychiatric disorders (Parkinson's disease, Alzheimer's disease and other cognitive disorders, bipolar disorder, and alcohol and drug dependence) and inflammatory diseases (rheumatoid arthritis, psoriasis, chronic obstructive pulmonary disease and others). It has several innovative small molecule and biological drug candidates at different stages of clinical development. Biotie's products address diseases with high unmet medical need and significant market potential.
Partnerships with top/tier pharmaceutical partners are in place for several programs as well as a strategic collaboration with UCB Pharma S.A. Biotie's most advanced product, nalmefene for alcohol dependence, is currently in Phase 3 clinical development by licensing partner H. Lundbeck A/S.
Biotie shares are listed on NASDAQ OMX Helsinki Ltd.
Posted: May 2011