Interim Management Statement

RNS Number : 0451X

Phytopharm PLC

05 February 2013

 

5 February 2013

Interim Management Statement

Phytopharm plc (PYM: London Stock Exchange) ("Phytopharm", the "Group" or the "Company") today issues its Interim Management Statement ("IMS") which relates to the period from 1 October 2012 to 5 February 2013 and contains information up to the date of publication of this IMS.

During the period

·     The last patient completed participation in the CONFIDENT-PD Phase II clinical trial of Cogane™ in untreated patients with early-stage Parkinson's disease in December 2012. Results from this trial remain on track to be available in February 2013.

·     Further work is ongoing with a number of leading opinion leaders and charities with an interest in Cogane™ in Amyotrophic Lateral Sclerosis ("ALS") to design a clinical development plan. Provisional indications for financial and logistical support for future studies of Cogane™ as a treatment for ALS have been received.

·     A meeting has been held with the US Food and Drug Administration ("FDA") at which a clinical development plan for Cogane™ in ALS was agreed. Cogane™ for ALS has been granted Orphan Drug status which offers the potential for accelerated development compared with conventional drug development programs.

·     A Phase I study of new solid dose formulations of Cogane™ was initiated and results are expected in Q1 2013.

·     Our financial performance from 1 October 2012 to date continues to be in line with our expectations. Based on our current expectations Phytopharm is financed until at least the end of Q1 2014.

Mr Tim Sharpington, CEO commented: "Whilst completing the CONFIDENT-PD clinical trial in Parkinson's disease the Company has been planning for the next stage of development. We have been pleased to receive the support of leading opinion leaders and charities for our development plans for Cogane™ in ALS, which we believe can add value alongside our work in Parkinson's disease. We have also had discussions with the FDA and potential pharmaceutical partners about how best to complete the development and commercialisation of Cogane™. The results from the CONFIDENT-PD clinical trial will be important in determining how our future strategy evolves and we look forward to receiving these results shortly".

Cogane™ in Parkinson's disease

Parkinson's disease is a movement disorder 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 slow in onset and the appearance of symptoms reflects the gradual loss of dopaminergic neurones.

Progress to date

Cogane™ in Parkinson's disease - progress to date

The preclinical neuroprotective profile of Cogane™ suggests that it will have benefit on both motor and non-motor symptoms of Parkinson's disease. In addition its effect on restoring damaged neurones to a functioning state implies that it might result in a delay in the progression of disease in recently diagnosed patients.

Cogane™ is currently being evaluated in a multi-national Phase II, randomised, double blind, placebo controlled, dose-ranging trial (CONFIDENT-PD). The trial is comparing the safety, tolerability and efficacy of three doses of Cogane™ and placebo when administered for 28 weeks to untreated patients with early-stage Parkinson's disease. The trial will assess the efficacy of Cogane™ in the treatment of both motor and non‑motor symptoms of Parkinson's disease.  The last patient completed the clinical trial in December 2012 and the results remain on track to be available in February 2013.

Data from preclinical models also indicates that in addition to its effectiveness as a monotherapy, Cogane™ administered in conjunction with L‑DOPA, a commonly used symptomatic treatment of Parkinson's disease, shows additional benefit over L‑DOPA alone. Other data suggests that Cogane™ co-administration reduces the side effects associated with L‑DOPA. If these effects of improved efficacy and reduced side effects of L‑DOPA by co-administration of Cogane™ are also observed in patients, this will have significant benefit in the management of patients with more severe, later stage disease.

Cogane™ is administered in a liquid formulation in the current CONFIDENT-PD clinical trial. In parallel to this trial the Group has been developing solid dose oral formulations which it believes may be a more commercially attractive proposition to take forward in Parkinson's disease.

Cogane™ in motor neurone disease / ALS

ALS, also known as Lou Gehrig's disease, is the most prevalent form of motor neurone disease which generally occurs in people between 40 and 60 years of age. It is characterised by progressive loss of both lower (spinal cord and brain stem) and upper (cerebral cortex) motor neurones, which leads to severe muscle weakness and wasting, followed by paralysis and death, generally caused by respiratory failure with only 50% of patients surviving 18 months  from diagnosis and only 20% surviving beyond five years from diagnosis⁽¹⁾. There is an urgent need for the development of new approaches to treat this devastating condition.

(Source: (1) ALS-TDI 2012)

Progress to date

In 2012 the Company announced the successful completion of the preclinical evaluation of Cogane™ in ALS. Collectively the results from four different models of motor neuron damage provided strong support for progression into clinical trials in this indication.

Subsequently the Company has been working with a number of leading opinion leaders and charities with an interest in ALS to design a clinical development plan for Cogane™ in ALS. As part of this process two leading grant-giving bodies, the ALS Association ("ALSA") and the North-East ALS Consortium ("NEALS") in conjunction with Massachusetts General Hospital, have provisionally indicated that they will provide financial and logistic support for future studies of Cogane™ in ALS. Both of these grants are contingent on the Company moving forward with a study in ALS.

The Company has also held a discussion with the US regulatory agency, the Food & Drug Administration, with regard to the design of a clinical development plan for Cogane™ in ALS.

Cogane™ has been granted Orphan Drug status by both the European Commission and by the US Food & Drug Administration for development in ALS and this will allow significant access to the regulatory authorities for advice and expedited clinical progression as well as providing financial advantages.

Glaucoma

Current pharmacological treatments for glaucoma are predominantly focused on reducing the elevated intra-ocular pressure ("IOP") in the eye, which is often associated with glaucoma. However, a significant number of patients with glaucoma do not exhibit raised IOP and, in addition, a significant number of patients whose IOP is successfully reduced still experience ongoing neurodegeneration resulting in deterioration of sight. It is therefore believed that there is a major unmet need and a commercial opportunity for products which could successfully treat the underlying neurodegenerative process in glaucoma.

Myogane™ in glaucoma - progress to date

Myogane™ has demonstrated neuroprotective effects in a range of preclinical models of neurodegenerative diseases. Specifically, Myogane™ has been shown to modulate the production of neurotrophic factors in a number of cell types and to have beneficial neuroprotective and neurorestorative effects on retinal ganglion cells, the cells which degenerate in glaucoma.

The Company has completed a study with Myogane™ in an animal model of glaucoma that was inconclusive. The study did not yield a valid result because of an unexpectedly low level of neuronal cell death in the control group which prevented evaluation of the neuroprotective effect of Myogane™. Further tests will be conducted in glaucoma when resources permit.

P61 programme - progress to date

The P61 programme was established to investigate the known pharmacological properties of curcumin and gingerol. P61 is a series of novel new chemical entities ("NCEs") which exhibit anti-inflammatory, anti-remodelling, anti-spasmodic and TRPV1 modulating activities. This range of activity within single molecules could provide attractive therapeutic options for a number of inflammatory diseases. A lead compound has been identified and is being characterised to better understand its pharmaceutical potential.

Finance

Our financial performance from 1 October 2012 to date continues to be in line with our expectations. Our CONFIDENT-PD clinical study is expected to generate clinical data in February 2013, which, if positive, will allow us to maximise shareholder value by seeking late-stage development and/or commercial partners as appropriate. We are also evaluating opportunities following the successful completion of our investigations into the effects of Cogane™ in ALS which may, funding dependent, allow us to investigate further efficacy-indicating clinical trials in this indication. We will continue to evaluate funding opportunities as they arise. We also expect to complete the current phase of the P61 programme.

In line with our virtual operational structure, we will continue to outsource the majority of our operations to specialist external organisations enabling us to operate with a low headcount and minimal infrastructure. Efficiency and cost control continue to be a key focus. Our lean operational structure continues to provide substantial cost and technical benefits as the nature and range of our activities evolve in tandem with our programmes' progress through the various stages of development. Based on our current expectations Phytopharm is financed until at least the end of Q1 2014.

Notes to Editors

Enquiries Phytopharm plc Tim Sharpington, CEO Roger Hickling, R & D Director [phone]

Broker Peel Hunt LLP James Steel Vijay Barathan [phone]

U.K. Investor Relations FTI Consulting LLP Ben Atwell John Dineen [phone]

Phytopharm plc

Strategy

Phytopharm plc ("Phytopharm") is a development stage pharmaceutical Group developing novel treatments targeting diseases with high levels of unmet need. Our lead series of compounds, the sapogenins (including Cogane™ and Myogane™), has the potential to be a new class of therapy for neurodegenerative diseases including Parkinson's disease, ALS and glaucoma.

Phytopharm operates as a virtual Group ensuring the majority of our financial resources are focussed on 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.

Our commercially focused development programmes have the potential to produce significant treatment advances in our target areas of neurodegeneration and inflammatory disease. Our products are single chemical entities with novel mechanisms of action protected by strong patent families. Our pipeline has been sourced from our own research activities and from licensing activities, particularly from leading research institutions in China with which the Group has long-standing relationships.

Our objective is to develop products aimed at major markets with high unmet medical need to key value inflection points before seeking late-stage development and/or commercial partners as appropriate.

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

The sapogenins

Cogane™ and Myogane™ are structurally related, small molecule, chemical entities and members of the sapogenin class of compounds.

Cogane™	Myogane™
Orally bioavailable neurotrophic factor modulators that readily cross the blood-brain barrier
Demonstrated neuroprotective effects in a range of preclinical models
Induce and modulate the production of neurotrophic factors
Completed long-term toxicology studies
Formulated as once daily, orally administered therapies with good bioavailability and safety profiles
Currently being evaluated in a Phase II trial of untreated patients with early stage Parkinson's disease (CONFIDENT-PD)	Evaluated in a preclinical model of glaucoma. The results were inconclusive because of an unexpectedly low level of neuronal cell death in the control group which prevented evaluation of the neuroprotective effect of Myogane™
Evaluated for safety and tolerability in patients with Alzheimer's disease
Positive results in preclinical models of ALS which provides strong support for the utility of Cogane™ in the treatment of this condition

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.

 

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