Announcement
Oxford Pharmascience : Preliminary PK Data & Initiation of Further Study
RNS Number : 7988V
Oxford Pharmascience Group PLC
12 August 2015
Oxford Pharmascience Group plc
("Oxford Pharmascience" or the "Company")
Preliminary Pharmacokinetic Data and
Initiation of Pilot Clinical Study
to Demonstrate Improved GI Profile for OXPzero™ Ibuprofen
Oxford Pharmascience Group Plc (AIM: OXP), the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, today announces that preliminary pharmacokinetic (PK) data confirms that OXP001(2) has successfully met its optimisation objectives for immediate release and complete drug absorption. The Company has commenced dosing in the second phase of the study, which seeks to prove the reduced gastro-intestinal (GI) irritation benefit of OXPzero™ Ibuprofen by endoscopic evaluation.
The randomized pilot PK study was a single-dose, two-arm UK study comparing the OXP001(2) 400mg chewable OXPzero™ Ibuprofen tablet and the reference Brufen® 400mg tablet (ibuprofen), in ten subjects. Preliminary PK data show comparable AUC (Area Under the Curve or total drug exposure over time) and tmax (time to reach maximum serum concentration) results, demonstrating that OXP001(2) is now a product with immediate and complete drug release characteristics. While the PK profile of the product appears to be similar to that of Brufen® on these measures, the maximum level of drug concentration in plasma (Cmax) appears to be lower compared to Brufen® but remains well within the range which the drug has therapeutic effect. The Company believes this preliminary PK data represents an acceptable clinical profile suitable for commercialisation. Additional PK data will be collected during the next phase of the study.
The taste masked benefit of OXPzero™ Ibuprofen was also assessed via subject interviews, during the first phase of this study, with consistent feedback confirming that the chewable tablets were tasteless, with none of the burn or after-taste issues associated with standard ibuprofen.
Following analysis of the preliminary PK data, the Company is proceeding to the second phase of the study, which aims to demonstrate a significantly reduced GI side effect profile compared to standard 400mg Brufen® tablets. The product to be tested, OXP001(2), is a 400mg chewable, taste masked, oral formulation of ibuprofen.
This phase of the study is a randomised, assessor-blinded, controlled pilot clinical study to assess the severity of upper GI damage via endoscopic assessment following 7 days' treatment of 2.4g/day of ibuprofen dosed as either OXP001(2) or Brufen®. A prior study in 2014 demonstrated significant GI side-effect benefits, compared to Brufen®, using an early version of OXP001 for which the PK profile has since been optimised for immediate release and complete drug absorption. Headline results on the second phase are expected to be released in Q4 2015, along with complete PK data and further taste masking assessments.
Marcelo Bravo, Chief Executive Officer, commented:
"We are pleased to confirm that OXP001(2) now achieves immediate release and complete drug absorption in vivo and that the taste masking benefit of the technology has been validated. We are confident the product is achieving release properties in line with the objective of delivering a reduction in GI irritation. Demonstrating that OXP001(2) achieves a significant reduction in GI erosions compared to Brufen® in this new formulation will validate OXPzero™ Ibuprofen as a disruptive compound in the major $4bn ibuprofen market."
Further details about the study can be found at www.ClinicalTrials.gov.
For further information:
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Oxford Pharmascience Group Plc |
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Marcelo Bravo, Chief Executive |
+44 20 7 554 5875 |
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N+1 Singer (Nominated Adviser & Broker) |
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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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