Results From Cogane in Parkinson's Disease Clinical Trial
Phytopharm plc (PYM: London Stock Exchange) (“Phytopharm”, the “Group” or the “Company”) today announces the results of the Phase II, randomised, double blind, placebo controlled, dose-ranging trial of Cogane™ in unmedicated patients with early-stage Parkinson’s disease (“CONFIDENT-PD”).
Analysis of the headline results indicated that Cogane™ had no beneficial effects on patients’ symptoms measured by the primary or secondary endpoints in the study.
Study details
Over four hundred subjects with early-stage Parkinson’s
disease were randomly allocated to receive either Cogane™ 60
mg, 120 mg or 180 mg, or placebo, which was taken orally, once
daily for up to 28 weeks. Measurements were taken during the study
to determine the efficacy, safety and tolerability of each dose of
Cogane™ compared with placebo and also the systemic exposure
to Cogane™.
The prospectively defined primary endpoint in this study was the change in the combined UPDRS II/III (an assessment of activities of daily living and motor symptoms) score from baseline to end-of-treatment for each dose of Cogane™ vs. placebo. A number of secondary efficacy outcome measures were also explored.
No statistically significant effects or trends towards improvement were seen in any of these endpoints. Analysis of the results indicates that the study was well conducted and gave a clear, albeit negative result.
Review of the safety data confirmed that Cogane™ administered orally once daily for up to 28 weeks was well tolerated.
The full results of the study will be published in an appropriate scientific forum in due course.
Professor C Warren Olanow, Professor of Neurology and
Neuroscience at Mount Sinai Medical School and Co-chief
Investigator for the study commented: “This is disappointing
news for the Parkinson disease community. Trophic factors that
enhance and restore function to remaining nerve cells is an
extremely promising approach for the treatment of neurodegenerative
disorders such as Parkinson’s disease. Cogane™ offered
the potential of providing trophic effects throughout the brain
with an oral medication that was relatively safe and well
tolerated. The company is to be congratulated for carrying out this
important study in such a high quality manner. Sadly, the results
are negative. Nonetheless, the search for more effective therapies
for the millions of patients who suffer from Parkinson’s
disease must continue.”
Commenting on these results, Tim Sharpington, CEO said: “We
are naturally disappointed with the outcome of this study of
Cogane™ in patients with Parkinson’s disease.
Cogane™ had demonstrated encouraging efficacy in a wide range
of industry standard pre-clinical models but this promise has not
translated into clinically meaningful efficacy in this study. I
would like to thank the investigators who conducted the trial, our
collaborators and especially the patients who participated in the
study, along with the Parkinson’s disease community and all
our stakeholders who have supported the development of
Cogane™.
During the coming weeks we will further analyse these results with
our scientific advisors to better understand whether to continue
the development of Cogane™ and Myogane™. In addition, a
review of other strategic options for the Company will be initiated
by the Board and shareholders will be kept informed of progress. No
further R&D expenditure will be committed whilst this review is
taking place.”
Notes to Editors
Enquiries
Phytopharm plc
Tim Sharpington, CEO
Roger Hickling, R & D Director
+44 1480 437 697 U.K. Investor Relations
FTI Consulting Limited
Ben Atwell
John Dineen
+44 207 831 3113
About Phytopharm
Strategy
Phytopharm plc (“Phytopharm”) is a development stage pharmaceutical Group developing novel treatments targeting diseases with high levels of unmet need, with the objective of developing products to key value inflection points before seeking late-stage development and/or commercial partners, as appropriate.
Phytopharm operates as a virtual Group ensuring the majority of
our financial resources are focussed on the development our
pharmaceutical pipeline. We utilise a network of external
scientific and clinical experts to help guide our development
programmes with our experienced pharmaceutical managers overseeing
operations.
Given the disappointing results from the CONFIDENT-PD clinical
trial reported today and the importance of Cogane™ to
Phytopharm’s development pipeline, the Company’s future
business strategy is under review.
As at 31 January 2013 the Group had unaudited net cash and cash
equivalents (including money market investments) of approximately
£5.5 million.
Phytopharm shares are included on the Premium Segment of the official list of the UKLA and are traded on the London Stock Exchange main market (Symbol: PYM). Further information on Phytopharm is available from the Company’s website www.phytopharm.com
Parkinson’s disease
Parkinson's disease (“PD”) is a movement disorder
affecting 1 in 100 people over 60 years of age and is characterised
by muscle rigidity, tremor and a slowing of physical movement
(bradykinesia) and, in extreme cases, a loss of physical movement
(akinesia). The primary symptoms are the result of altered
signalling in an area of the brain, the striatum, responsible for
the control of movement. This is caused by degeneration of
dopaminergic neurones that project from the substantia nigra to the
striatum, leading to insufficient formation and action of dopamine.
Parkinson’s disease is therefore termed a neurodegenerative
disease. The disease is relatively slow in its onset, with the
appearance and worsening of symptoms reflecting the progressive
loss of dopaminergic neurones. There is increasing awareness within
the field, of the non-motor symptoms of PD (e.g. cognitive
impairment, depression and anxiety, sleep difficulties, anosmia,
constipation, speech problems), which have a major impact on
patients and their families/carers.
Most patients with PD have only a slightly reduced lifespan, although quality of life during the advanced staged of the disease is often poor especially for those patients with dementia. Patients often become severely disabled as symptoms cannot be adequately controlled by current drug therapies, which may also be associated with severe side effects.
Cogane™ in Parkinson's disease
Cogane™ has previously been shown to demonstrate neuroprotective and neurorestorative properties in a number of industry-standard preclinical models of Parkinson’s disease and other neurodegenerative diseases conducted at independent laboratories. It has been formulated as a once-daily oral medication which was shown to be well tolerated and have good bio-availability in Phase I clinical studies.
CONFIDENT-PD
The CONFIDENT-PD trial was a multi-national, Phase II, double blind, placebo controlled, dose ranging clinical trial which compared the efficacy, safety and tolerability of three doses of Cogane™ with placebo, when administered for 28 weeks to unmedicated patients with early-stage Parkinson’s disease. Importantly, this trial assessed the ability of Cogane™ to affect both the motor and non-motor symptoms of Parkinson’s disease. In this trial, over 400 patients were randomised across more than 90 sites in North America and Europe.
Primary endpoint
The primary efficacy endpoint of the CONFIDENT-PD clinical trial
was the change from baseline to end-of-treatment on the Unified
Parkinson’s disease rating scale (“UPDRS”), Parts
II and III combined. The UPDRS is a well-established and
widely-used tool used to assess patients’ PD symptoms. UPDRS
Part II is an assessment of the impact of PD on activities of daily
living (“ADL”), which include routine tasks such as
doing up buttons and shoe laces. UPDRS Part III is an assessment of
patients’ motor symptoms (e.g., gait, bradykinesia, postural
stability, tremor).
Secondary endpoints
The scales for outcomes in Parkinson's disease-cognition tool
(“SCOPA-COG”) is an assessment designed specifically to
assess the impact of PD on cognitive function by measuring
performance on a number of tasks relying on memory, learning
ability, level of attention, executive decision-making and
visuo-spatial function. The non-motor symptom scale
(“NMSS”) is a rating scale used to assess a broad
spectrum of important non-motor features associated with PD.
The Parkinson’s disease 39 instrument (“PDQ-39”) is a quality-of-life (“QoL”) questionnaire which generates a profile of scores, providing a subjective indication of the effect of PD on patients’ QoL
The Beck depression inventory, 2nd revision (“BDI-II”) is a questionnaire for assessing depression.
The Epworth Sleep Scale (“ESS”) is a well-established questionnaire used to assess the level of excessive daytime sleepiness.
Forward looking statements
Certain information included in these statements is forward-looking and involves risk and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements.
Forward looking statements include, without limitation, projections relating to results of operations and financial conditions, market estimates, the Group’s plans and objectives for future operations, including future revenues, financial plans and expected expenditures and divestments. All forward-looking statements in this report are based on information known to the Group on the date of this release. The Group undertakes no obligation to publicly update or revise any forward looking statement, whether as a result of new information, future events or otherwise.
It is not reasonably possible to itemise all of the many factors
and specific events that could cause the Group’s forward
looking statements to be incorrect or that could otherwise have a
material adverse effect on the future operations or results of the
Group.
Posted: February 2013
