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Ibuprofen progressing to proof of concept trial

15th May 2015 07:22

RNS Number : 2857N
Oxford Pharmascience Group PLC
15 May 2015
 



Chewable Form of OXPzero™ Ibuprofen progressing to Proof-of-Concept Clinical Trial

 

Oxford Pharmascience Group Plc (AIM: OXP), the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, today announces completion of the development of an immediate release, taste masked, chewable 400mg ibuprofen product that is now ready for clinical evaluation. OXPzeroTM Ibuprofen (OXP001) delivers 400mg of reduced gastric irritation ibuprofen via the Company's patent protected OXPzero™ technology.

 

In January 2015, the Company announced that OXPzero™ Ibuprofen had been successfully optimised to deliver an immediate release tablet that demonstrated in vitro equivalence to standard Brufen® (400mg Ibuprofen tablet) and that a proof-of-concept clinical study with the optimised tablet was expected to begin in Q2 2015.

 

The Company has now developed a chewable 400mg ibuprofen tablet that is not only expected to reduce the risk of GI irritation but also to taste mask the bitter taste of the ibuprofen via OXP's patent protected OXPzero™ technology. Patient compliance to long-term therapy for chronic illnesses is a key issue and is reported to be around only 50% in developed countries.1 Providing patients with a GI safe treatment option, delivered in an easier to take dosing mechanism is believed to be a significant advantage in the non-steroidal anti-inflammatory drug (NSAID) treatment arena. The Company believes this would lead to improved patient compliance amongst long-term usage patients.

 

The Company has now decided to proceed to a proof-of-concept clinical trial with the chewable tablet and is planning to begin dosing in July 2015 with headline pharmacokinetic data also expected in July 2015. Endoscopy data to prove the reduction in GI irritation is due to follow in late Q3/early Q4 2015.

 

NSAIDs are one of the most widely used classes of drugs, with combined annual sales in excess of $12bn2 and more than 30 million users worldwide consuming NSAIDs each day3. 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 and diclofenac for pain and inflammation and aspirin for primary and secondary prevention of cardiovascular disease.

 

Ibuprofen is currently the dominant NSAID molecule in the pain relief and anti-inflammatory sector. Worldwide sales of Ibuprofen are in excess of $4bn per annum at manufacturers selling prices2. The Company hopes to provide the market with a much differentiated product, offering both a GI safer alternative to current NSAIDs and varied finished product forms to improve compliance rates.

 

Marcelo Bravo, Chief Executive Officer, commented:

 "The development and progression of a chewable taste masked ibuprofen tablet to the clinic will not only provide the data to further confirm the GI irritation reduction benefit of the OXPzero™ technology but will also provide evidence in a clinical setting of its taste masking ability. Successful data from this study alongside data from OXPzero™ Naproxen will provide a robust data package moving forward into commercialisation of these assets."

 

Sources

1. WHO Report "Adherence to long-term therapies. Evidence for action. 2003.

2. Evaluate Pharma

3. Black Swan Analysis Ltd - Market Evaluation for OXPZero™ technology to improve compliance with leading NSAID brands, November 2013 (commissioned by OXP)

For further information:

Oxford Pharmascience Group Plc

Marcelo Bravo, Chief Executive

+44 207 554 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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