Successful Pilot Clinical Study

Successful Pilot Clinical Study ofImmediate Release OXPzero™ Naproxen

Oxford Pharmascience, the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, today announces that the pilot comparative pharmacokinetics ("PK") study of OXPzero™ Naproxen ("OXP 005"), which commenced on 5 March, has been successful and the headline data from the trial demonstrates bioequivalence of OXP005 to Naprosyn® (generic naproxen).

OXPzero™ Naproxen aims to deliver 250mg of reduced gastric irritation naproxen via the Company's patent protected OXPzero™ technology in an immediate release oral formulation in order to provide a significantly reduced gastrointestinal (GI) side effect profile compared to standard naproxen tablets.

The headline PK data showed results which demonstrate bioequivalence and that the OXPzero™technology has been successfully optimised to enable immediate and complete drug release.

Full results of the study will be published in the following weeks. Based on this data, the company will now progress to a proof of concept endoscopy study to demonstrate the reduced GI irritation benefit of OXPzero™ Naproxen, as was previously demonstrated for OXPzero™ Ibuprofen in an earlier formulation.

Non-steroidal anti-inflammatory drugs (NSAIDs) are one of the most widely used classes of drugs, with combined annual sales in excess of $12 billion and more than 30 million users worldwide consuming NSAIDs each day (source: Evaluate Pharma). Chronic use of NSAIDs causes well-documented GI side effects, including ulcers and bleeding, and leads to significant morbidity and mortality in a substantial number of patients, with significant associated healthcare costs. The OXPzero™ platform technology reduces these risks and is being selectively applied to the most commonly used NSAID molecules, namely ibuprofen, naproxen, diclofenac and aspirin.

Marcelo Bravo, Chief Executive Officer of Oxford Pharmascience commented: 

"Demonstrating the bioequivalence of immediate release OXPzero™ Naproxen is a great result and a significant milestone for Oxford Pharmascience. This allows us to proceed with confidence to the endoscopy trial to demonstrate the reduced gastric irritation benefit of OXPzero™ Naproxen, and also confirms that the technology has been successfully optimised to achieve immediate and complete drug release. Oxford Pharmascience will now continue to progress confidently with our clinical programmes for both OXPzero™ Naproxen and OXPzero™ Ibuprofen."

Further information about the study:

The randomised pilot PK study, which was conducted by Quotient Clinical in the UK, was a single-dose, two arm study between OXPzero™ Naproxen and the reference Naprosyn® 250mg tablets with ten subjects in each arm. Headline PK data show mean AUC (Area Under the Curve or total drug exposure over time) and mean Cmax (maximum serum concentration) results meet the bioequivalence criteria, demonstrating that the OXPzero™ technology has been successfully optimised to enable immediate and complete drug release. Further details about the study can be found at www.ClinicalTrials.gov, ref: NCT02351024.

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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.