Chewable Form of OXPzero(TM) 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. OXPzero(TM) Ibuprofen (OXP001) delivers 400mg of reduced gastric irritation ibuprofen via the Company’s patent protected OXPzero(TM) technology.
In January 2015, the Company announced that OXPzero(TM) Ibuprofen had been successfully optimised to deliver an immediate release tablet that demonstrated in vitro equivalence to standard Brufen(R) (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(TM) 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 $12bn(2) and more than 30 million users worldwide consuming NSAIDs each day(3) . 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(TM) 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 prices(2) . 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(TM) technology but will also provide evidence in a clinical setting of its taste masking ability. Successful data from this study alongside data from OXPzero(TM) Naproxen will provide a robust data package moving forward into commercialisation of these assets.”