ABACO CAPITAL PLC
Oxford Pharmascience Group plc
("Oxford Pharmascience" or the "Company")
Successful optimisation of OXPZeroTM Ibuprofen (OXP001) and progression to pilot clinical study
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 optimisation of OXPzeroTM Ibuprofen (OXP001) to deliver a product offering immediate release of the drug and the appointment of a clinical research organisation (CRO) to conduct a further clinical proof-of-concept study for this product.
Highlights
· OXPzeroTM Ibuprofen successfully optimised to deliver an immediate release product that demonstrated in vitro equivalence to standard Brufen (Ibuprofen)
· Appointment of UK based Quotient Clinical to perform clinical proof-of-concept study to confirm significantly less gastrointestinal (GI) irritation observed in earlier study
· Preliminary study results expected mid 2015
In June 2014, the Company announced the positive results of its proof-of-concept clinical study to determine the extent of upper GI tract irritation of the 400mg OXPzeroTM Ibuprofentablet (OXP001) compared to the standard 400mg Brufen (Ibuprofen) tablet. The results showed significantly less GI irritation after administration of OXP001compared to standard Ibuprofen, but that minor optimisation work was required to ensure bioequivalence of OXP001 vs. Brufen.
The Company has now successfully optimised both the active pharmaceutical ingredient (API) and the formulation, developing an immediate release product that achieves comparable in vitro drug release to the Ibuprofen reference. The Company is now proceeding to conduct a proof-of-concept clinical study with the optimised product.
T he Company has appointed Quotient Clinicalto conduct the upcoming study with OXPzeroTM Ibuprofen in the United Kingdom. This is the same CRO that conducted the proof-of-concept clinical study in 2014. The study for OXPzeroTM Ibuprofen has already received ethics committee approval and is expected to begin in Q2 2015 with headline PK data expected by mid-2015 and headline endoscopy data expected in Q3 2015. Further details will be provided in the coming weeks.
The optimisation work and progression to clinical study is a key milestone in the Company's programme to develop a range of prescription and over-the-counter strength non-steroidal anti-inflammatory drugs (NSAIDs), as well gastric safe taste-masked paediatric formulations and will provide the Company with the data required to provide a robust data package to initiate the commercialisation of these clinical stage assets.
Development work on the Company's other OXPzeroTM NSAID molecules (naproxen, diclofenac and aspirin) is continuing and Oxford Pharmascience expects to update the market regarding these molecules 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 with 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 TM 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. Ibuprofen accounts for approximately 35 per cent or $4 billion of the $12 billion annual sales value of NSAIDs (source: Evaluate Pharma) .
Marcelo Bravo, Chief Executive Officer, commented:
"Clinical evidence to demonstrate bioequivalence and confirm the significant reduction in gastrointestinal irritation observed in the earlier study for our optimised OXPzeroTMIbuprofen, compared to standard Ibuprofen, will represent a further major milestone for the Company. Gastric safe NSAIDs are a major commercial opportunity and we believe we are well placed to start seeking partnerships with major pharmaceutical companies during 2015. The Company is now poised to begin realising significant value from the OXPzero TM platform as further data emerges during 2015 and beyond."
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
This information is provided by RNS
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