REG - Oxford Pharmascience - Results from Pilot Clinical Study of OXP500 <Origin Href="QuoteRef">OXP.L</Origin> <Origin Href="QuoteRef">VSVS.L</Origin>

VesuviusAnnouncement

31/07/2015 07:01

RNS Number : 6490U
Oxford Pharmascience Group PLC
31 July 2015
Oxford Pharmascience Group plc
("Oxford Pharmascience" or the "Company")
Encouraging Results
from Pilot Clinical Study of OXPzeroTM Naproxen (OXP005)
Oxford Pharmascience, the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, today announces the results of its proof of concept clinical study to determine the extent of upper gastrointestinal (GI) tract irritation of its OXPzeroTM 250mg tablet ("OXP005") compared with the Naprosyn 250mg (Naproxen) tablet by endoscopic evaluation. Further details are included below and more information can be found atwww.ClinicalTrials.gov.
HIGHLIGHTS
 Achieved a statistically significant reduction in the number of upper gastrointestinal erosions observed by endoscopy after administration of OXP005 compared to Naprosyn in healthy volunteers.
 Lanza score (a clinical rating score of gastrointestinal irritation in the stomach and duodenum on endoscopic evaluation) was comparable between OXP005 and Naprosyn.
 PK data confirms bioequivalence of OXP005 and Naprosyn at Day 1 and Day 7.
 The Company believes the technology can be further optimized specifically for naproxen and a programme to define the improved product is being initiated.
The primary endpoints of the study were 1. a comparison of the overall Lanzascore and 2. a comparison of the total number of erosions observed in the stomach and duodenum. 
In the study both OXP005 and Naprosyn exhibited a similar Lanza score while OXP005 exhibits a moderate (c. 26%) reduction in total erosions, albeit at a non statistically significant level. 
OXP005 meets the primary endpoint of reduced erosions exhibiting a major (c. 38%) reduction of total erosions which is statistically significant after accounting for ineligible subjects. While OXP005 is reducing the number of erosions, the Lanza score endpoint was not met. 
The pharmacokinetic (PK) data obtained on Day 1 of the study confirm results observed in the first phase of the study and also confirm that on Day 7 OXP005 is fully bioequivalent to Naprosyn based on mean values of core PK measures as detailed below. 
Oxford Pharmascience is encouraged by these results and believes that further work will bring the OXPzeroTM Naproxen technology to its full potential. OXP005 was a direct re-application of the technology as developed for ibuprofen, which is known to cause less upper GI irritation than naproxen. 
The Company believes it can further improve these results by adapting OXPzero specifically for the naproxen molecule. In the past few months a significant understanding of the technology and its ability to be modified has been gained in the lab and through its clinical trial observations and this will be applied to reiterate with a reformulated OXP005. 

Headline pharmacokineticdata from a further pilot clinical study of OXPZeroTM Ibuprofen (OXP001) in an optimized, chewable form, will be reported in the coming weeks. 
The Company plans to begin partnering discussions in the coming months with opportunities evaluated on the basis of both current and anticipated data, with the aim of achieving the optimal commercial outcome and value for shareholders. The Company's strong balance sheet provides greater commercial flexibility as it enters these discussions, including to conduct further work to adapt the platform for naproxen. 
Marcelo Bravo, Chief Executive Officer, commented:
"We are encouraged by these results and take confidence from the fact that we now have two clinical data sets for OXPzeroTM variants of major NSAIDs demonstrating reduced GI irritation. Ibuprofen and naproxen account for $4.8 billion of the total $12 billion global market. We are confident in the future potential of the OXPzeroTM platform as we implement the further work to be done to exploit the full potential of naproxen and provide further data to support commercial discussions. With additional funds on board to allow us to generate further data, and additional endoscopy data from our further pilot clinical study for ibuprofen expected by the end of October, the plan remains to commence partnering discussions with the aim of maximising future value for the Company and its shareholders.
We look forward to providing further updates on our development pipeline, including the OXPzeroTM NSAIDs programme and other OXPzeroTM applications and the OXPtargetTM SafestatTM programme and other OXPtargetTM applications."
Summary PK Data
OXP005 achieved mean relative values for absorption (Area Under the Curve, AUC) and maximum concentration (Cmax) of 101.9%and 86.1%respectively on Day 1 and 105.6% and 91.7% respectively on Day 7. The mean values for AUC and Cmax are within the guidelines for bioequivalence (80.0 to 125.0%).
For further information:
Oxford Pharmascience Group Plc

Marcelo Bravo, Chief Executive
+44 20 7554 5875


N+1 Singer (Nominated Adviser & Broker)

Aubrey Powell/Jen Boorer
+44 20 7496 3000
About Oxford Pharmascience Group Plc
Oxford Pharmascience Group Plc uses a range of proprietary technology platforms to re-develop existing medicines to make them better, safer or easier to take. The Company does not manufacture or sell its own pharmaceutical products direct to consumers but instead seeks to license its technologies and dossiers to a network of partners, mainly leading pharmaceutical companies with Rx (prescription) and OTC (Over the Counter) branded portfolios.
Oxford Pharmascience Group Plc focuses on existing medicines that are proven to be safe and effective but nevertheless still have associated issues and side effects often affecting compliance. By working with such medicines the Company is able to develop new innovative products for a fraction of the cost, in much quicker timescales and without the high risk of failure associated with developing new drugs.

This information is provided by RNS
The company news service from the London Stock Exchange
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