Oxford Pharmascience Group Plc | Medicines made better

 

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23 February 2017

OXPzero™ Ibuprofen - Positive Exploratory PK Study Data

Oxford Pharmascience (AIM: OXP), the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, provides the following update on its lead OXPzero™ Ibuprofen clinical programme.

On 17 January 2017 the Company confirmed that it had started dosing of healthy subjects in its Phase I exploratory pharmacokinetic (PK) study "OAT-01", as previously outlined in an earlier announcement dated 9 November 2016. OAT-01 is a three-part, open label, active controlled, crossover study designed to assess the PK profile of the lead OXPzero™ Ibuprofen technology modifications against licensed ibuprofen products to verify that the improvements in speed of ibuprofen release seen in laboratory studies translate into improvements in healthy human subjects. Interim PK data from the first part of the study in 10 subjects indicate that the technology modifications can successfully change the PK profile of ibuprofen released into the body from OXPzero™ Ibuprofen and that it is possible to achieve a PK profile comparable to Nurofen™ (a licensed over-the-counter ibuprofen product) displaying:

  • equivalent maximum plasma levels (Cmax);
  • equivalent total absorption of ibuprofen (AUC); and
  • a faster rate of absorption (Tmax) (i.e. onset of efficacy).

In addition, alternative technology modifications are able to achieve a PK profile for OXPzero™ Ibuprofen with a slower rate of release and extended duration of effect as compared to Nurofen™.

The OAT-01 study will continue as planned to further elucidate the range of impact on PK by the technology modifications. Further data from this study will help select the optimal technology modifications to guide subsequent formulation development of over-the-counter and prescription strength products. The Company do not intend to announce further OAT-01 study results since details of the technology modifications are the subject of a recently filed UK patent application with international filings to be expanded over the next two years as the UK application progresses. Further details on the OAT-01 study can be found at ClinicalTrials.gov using the identifier NCT02974361.

Commenting on the results, CEO Marcelo Bravo said:

"Oxford Pharmascience is very pleased with these exploratory, interim PK study results, which demonstrate that the technolology modifications can not only make OXPzero™ Ibuprofen bioequivalent to ibuprofen free acid (Nurofen™), but also potentially faster acting. Achieving a product that is bioequivalent to reference is highly important to OXP as the regulatory pathway to gaining product approval generally becomes faster, simpler and therefore less costly for bioequivalent products. The potential to accelerate speed of action or to extend the duration of effect is expected to further differentiate prospective OXPzero™ products.

"These results indicate a strong position with an OXPzero™ Ibuprofen asset that can be made bioequivalent, completely taste masked and either faster acting or having an extended duration of effect compared to the reference product."

This announcement contains inside information.

 

For further information:

Oxford Pharmascience Group Plc  
Marcelo Bravo, Chief Executive +44 207 554 5875
   
N+1 Singer (Nominated Adviser & Broker)  
Aubrey Powell/Lauren Kettle +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.

About OXPzero™ non-steroidal anti-inflammatory drugs (NSAIDs)

Specifically, by comparison with generic NSAIDs, OXPzero™ Ibuprofen and OXPzero™ Naproxen are milder in the GI tract, delivering major reduction in severe GI mucosal damage, significantly mask the bitter taste/burn associated with NSAIDs, and deliver an attractive pharmacokinetic profile with adaptable drug release properties.

 

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