Naproxen Progresses into Proof of Concept Trials

Oxford Pharmascience Group Plc(AIM: OXP), the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, today announces the successful development of an immediate release clinical formulation of OXPzero™ Naproxen, which has been accelerated to clinical proof-of-concept with subject dosing planned to start during Q1 2015.


•       Successful development of immediate release clinical formulation of OXPzero™ Naproxen that demonstrated in vitro equivalence to standard naproxen tablets

•       Appointment of Quotient Clinical to conduct two clinical proof-of-concept studies, which aim to demonstrate (1) a comparable pharmacokinetic (PK) profile and 2) reduced gastrointestinal (GI) side effects of OXPzero™ Naproxen versus standard naproxen tablets (the "PoC Studies")

•       Headline PK results expected by the end of Q1 2015, and headline endoscopy data expected in Q2 2015
Following the September 2014 announcement that the Company had successfully synthesised OXPzero™Naproxen at lab scale, the Company is pleased to announce that an immediate release clinical formulation has been successfully developed. Final preparations are being made to progress this programme through the two PoC Studies, with the ethics committee application and the MHRA clinical trial application already submitted.

The Company has appointed UK-based Quotient Clinical as its clinical partner to run these PoC Studies (as well as the recently announced OXPzero™ ibuprofen study), using its in-house formulation development, GMP manufacturing and clinical facilities.  The PoC Studies aim to demonstrate (1) a comparable PK profile of 250 mg OXPzero™ Naproxen tablets to 250 mg Naprosyn (standard naproxen) tablets and (2) proof-of-concept of reduced GI side effects compared to Naprosyn tablets.

Headline PK results are expected by the end of Q1 2015 with headline endoscopy data expected in Q2 2015. Further details on these trials will be provided in the coming weeks.

NSAIDs are one of the most widely used classes of drugs, with more than 30 million users worldwide consuming NSAIDs each day and combined annual sales in excess of $12 billion (source: Evaluate Pharma). However, chronic use of NSAIDs causes well-documented GI side effects, including ulcers and bleeding, and leads to significant morbidity and mortality in many patients. The OXPzero™ platform technology reduces these risks and is being selectively applied to the most commonly used molecules in the NSAID category, namely ibuprofen, naproxen, diclofenac and aspirin, to maximise both the significant health benefits to users and the capture of commercial value for the company over the medium term. Ibuprofen, naproxen and diclofenac are the most commonly used drugs for pain and inflammation (accounting for 76 % of chronic pain prescriptions in the US and Europe in 2013) and aspirin is widely used as an antiplatelet agent. Naproxen accounts for approximately 7% or c. $815 million of the $12 billion annual sales value of NSAIDs (source: Evaluate Pharma).

Marcelo Bravo, Chief Executive Officer of Oxford Pharmascience, commented:

"The progression to proof of concept studies for naproxen brings the Company significantly closer to proving that the OXPzero™ proprietary platform technology can be applied across a range of molecules in the vast NSAIDs market, and to providing a robust data package to support the commercialisation of our NSAID clinical stage assets. Naproxen alongside ibuprofen are two of the most widely used NSAIDs in both over-the-counter and prescription markets, and advancing these two lead programmes in parallel significantly strengthens our commercial profile and offering. Gastric-safe NSAIDs are a major opportunity and the Company is poised to begin realising significant value from this during 2015 and beyond."

Mark Egerton, CEO of Quotient Clinical, added: "Using our Translational Pharmaceutics platform, we enable companies like Oxford Pharmascience to conduct clinical proof-of-concept studies faster and more effectively, by providing access to formulation development, real-time manufacturing and clinical testing capabilities at a single site,. We look forward to applying our unique approach to Oxford Pharmascience's OXP ZeroTM Naproxen and Ibuprofen studies."   

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