Oxford Pharmascience Group Plc | Medicines made better

 

News

17 January 2017

Technical, Clinical and Regulatory Update

Oxford Pharmascience Group plc (AIM: OXP), the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, provides the following update.

Highlights

  • Dosing commenced in the Phase I exploratory pharmacokinetic (PK) study designed to confirm improved release properties of OXPzero™ Ibuprofen
  • Confirmation that FDA responses on US regulatory pathway for OXPzero™ Ibuprofen over-the-counter (OTC) and prescription (Rx) categories are expected during Q1 2017
  • Successful manufacturing process validation of OXPzero™ Ibuprofen at intermediate scale
  • Further NSAID*, OXPzero™ Ketorolac, successfully synthesised at laboratory scale
  • Remains well funded to pursue strategy, with circa £21.9 million net cash at year end

As reported on 9 November 2016, the Company had completed laboratory work to identify modifications to the OXPzero™ technology platform that alter the release properties and enable faster release of the NSAID. Evaluation of the modified OXPzero™ Ibuprofen technology modifications in an in vitro gastric cell model developed by the University of Newcastle has shown that the modifications did not cause diminution in the viability of gastric cells. Therefore it is considered likely that the beneficial gastrointestinal effect of the OXPzero™ technology is preserved in the modified version(s).

Accordingly, the Company is now pleased to announce that dosing of healthy subjects in its Phase I exploratory PK study "OAT-01" has begun. 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 the lab studies translate into in vivo improvements. Further details on the study can be found at ClinicalTrials.gov NCT02974361. Dosing of all three study parts is due to be completed by the end of Q2 2017, with first readouts expected no later than Q2 2017.

The Company also announces that pre-IND** packages have been submitted to the FDA for both OXPzero™ Ibuprofen OTC and Rx programmes. The FDA has indicated that its formal feedback will be provided during Q1 2017 in written format only. Clarity on the regulatory pathway is expected to further facilitate partnering discussions for the key US market.

The Company is also pleased to announce that it has successfully synthesised a further NSAID molecule, ketorolac, at laboratory scale. Ketorolac is an NSAID in the family of heterocyclic acetic acid derivatives which is used for moderate-to-severe pain, often prescribed in place of opioids. The use of ketorolac is heavily restricted (to not more than five days) due to the potential of increasing the frequency and severity of adverse reactions which include gastro-intestinal bleeding. The Company believes that a safer version of ketorolac would be an effective alternative or complement to opioids in certain clinical settings.

In addition to the above developments, the Company has also completed intermediate scale process validation of OXPzero™ Ibuprofen. Three batches of 40 kilogrammes have been produced by the Company's contract manufacturer Dipharma Francis S.r.l. This is a significant achievement giving confidence that OXPzero™ products can be manufactured effectively at commercial scale and cost.

The Company continues in dialogue with prospective partners regarding these developments with a view to commercializing its OXPzero™ assets. Updates will be provided as required.

As at 31 December 2016, the Company had net cash of circa £21.9 million and remains well funded to pursue its strategy.

Commenting on the progress, CEO Marcelo Bravo said:

"We have focused on clinical and regulatory activities identified in our commercial interactions last year as being important to partners and we are pleased with the progress achieved in the past weeks. In parallel to these, our dialogue with prospective licence partners for our NSAID technology and assets continues, with a focus on prescription markets."

This announcement contains inside information.

*NSAID - non-steroidal anti-inflammatory drug
** IND - refers to the Initial New Drug application which is required by the FDA before any US clinical trials can commence

 

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™ 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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