Interim Management Statement

RNS Number : 4078M

Phytopharm PLC

16 August 2011

 



16 August 2011

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 April 2011 to 16 August 2011 and contains information up to the date of publication of this IMS.

Highlights for the period

·     Recruitment of patients with Parkinson's disease (PD) into the multi-national Cogane™ Phase II dose ranging study (CONFIDENT-PD) ongoing.

·     Achieved positive results demonstrating that Cogane™ reduced side effects associated with L-DOPA treatment in a preclinical model of PD; data presented at the Movement Disorders Conference in June 2011.

·     Positive preclinical in vitro data was presented at the World Glaucoma Congress in June 2011 supporting the ongoing development of Myogane™ in glaucoma.

·     United States Food & Drug Administration (FDA) granted Orphan Drug status to Cogane™ for the treatment of amyotrophic lateral sclerosis (ALS) in July 2011.

Cogane™ in Parkinson's disease

Cogane^TM is currently being evaluated in a 400 patient multi-national Phase II, randomised, double blind, placebo controlled, dose ranging study (CONFIDENT-PD). The study has been designed to compare the safety, tolerability and efficacy of three doses of Cogane^TM and placebo when administered for 28 weeks to untreated patients with early stage PD. Patient recruitment commenced in November 2010. Our target remains to have headline results from the study available at the end of 2012.

A preclinical model conducted by Phytopharm has shown that administration of Cogane^TM in conjunction with L-DOPA (the standard treatment for PD) resulted in improved control of symptoms compared to treatment with L-DOPA alone.  We have also now demonstrated that Cogane^TM  reduced the side-effects of L-DOPA in preclinical models; this data was presented at the International Congress of Parkinson's disease and Movement Disorders held in June 2011 in Toronto, Canada.  Together, these results demonstrate the potential of Cogane™ not only as a monotherapy for PD but also in combination with L-DOPA to widen the therapeutic window of L-DOPA. These data continue to support the development of Cogane^TM as a new and potentially disease-modifying therapy for PD. In addition to its effects in preclinical models of PD Cogane^TM has shown efficacy in preclinical models of cognitive impairment and therefore may have utility in treating the non-motor symptoms of PD. 

Cogane™ in motor neurone disease / ALS

We have initiated a study of Cogane™ in the genetic "gold standard" in vivo model of ALS, with the support of the Motor Neurone Disease Association, a UK based charitable organisation which has provided a grant to cover the costs of the study. Results from the study are expected in Q4 2011. As Cogane™ is already in clinical trials for PD, rapid progression into efficacy indicating trials will be possible, subject to funding, if results from this preclinical study are positive.

In July 2011, the FDA granted orphan drug status to Cogane™ for the treatment of ALS. For a product to gain Orphan Drug status in the United States, the clinical condition must affect less than 200,000 people in the United States. If a product has been granted orphan drug status, FDA will provide assistance in the design of the preclinical and clinical studies needed to achieve marketing approval for the designated clinical condition. Additionally, there are financial incentives available (such as waiver of the fee for the marketing application, currently $1.5m) and 7 years' marketing exclusivity (compared to 5 years available for non-orphan diseases). An application to gain Orphan Drug status in the European Union has also been made to the European Medicines Agency.

Myogane™ in glaucoma

Following a preclinical assessment of Cogane™ and Myogane™ in glaucoma, a neurodegenerative condition of the eye, Myogane™ has been selected for further investigation. Preclinical in vitro data was presented at the World Glaucoma Congress in June 2011. The assessment of efficacy using an in vivo preclinical model of glaucoma is ongoing and results from this model will be available in Q4 2011.

P61 in Inflammatory Disease

P61 is a series of novel new chemical entities which exhibit anti-inflammatory, anti-remodelling, anti-spasmodic and TRPV1 modulating activities. This range of activity within single molecules could provide attractive therapeutic options in a number of inflammatory diseases. A lead optimisation programme has been conducted and a lead candidate has been selected for further evaluation.

Finance

We continue to focus our resources on our lead programme, Cogane™ in PD, together with the next stage of development of our sapogenin programmes investigating the effects of Cogane™ in ALS, Myogane™ in glaucoma. We are also completing the current phase of the P61 programme. Our financial performance from 1 April 2011 to date has been in line with our expectations. We continue to operate with a lean operational structure whilst also diversifying our development pipeline in a cost efficient manner, with the potential for further programmes to enter the clinic or become licensed in the medium term. Based on our current expectations Phytopharm is financed to the end of 2013.

Notes to Editors

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

U.K. Investor Relations FD Ben Atwell John Dineen [phone]

Phytopharm plc

Phytopharm is a development stage pharmaceutical company 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 PD, ALS and glaucoma.

Phytopharm's strategic direction has evolved from developing products extracted from natural botanical sources to investigating single chemical entities.

Phytopharm operates as a virtual company. We utilise a network of scientific and clinical experts to help guide our development projects, with our experienced pharmaceutical managers overseeing operations.

Our commercially focussed development projects 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 whom the company 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 commercial partners as appropriate. We will consider retaining certain rights to products targeting orphan indications.

The sapogenins

Cogane^TM and Myogane^TM are structurally related, small molecule, chemical entities and members of the sapogenin class of compounds. They are orally bioavailable neurotrophic factor modulators that readily cross the blood-brain barrier. Both compounds have demonstrated neuroprotective effects in a range of preclinical models. Specifically, Cogane^TM and Myogane^TM have been shown to induce and modulate the production of neurotrophic factors.

Both compounds have completed long term toxicology studies, have been formulated as once daily, orally administered therapies and have completed Phase I studies demonstrating good bioavailability and safety profiles.

Phytopharm is listed on the Official List of the London Stock Exchange. Further information on Phytopharm is available from the Company's website www.phytopharm.com

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 the Group's plans and objectives for future operations, including future revenues, financial plans and expected expenditure and divestments. All forward looking statements in this report are based upon information known to the Group at 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 of the Group.

 

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