Oxford Pharmascience’s aims clearing regulatory pathway for OTC and Rx OXP zero NSAID products

Oxford Pharmascience Group, the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, has provided the following update on the development of its R&D pipeline.

OXPzeroTM

As reported within the interim results, the Company continues commercialisation discussions for its lead assets, OXP zero Ibuprofen and OXP zero Naproxen. In parallel, the Company has focused its technical activities on advancing the OXP zero technology to affect and control release properties, scaling-up and optimising the manufacturing process and strengthening its intellectual property (IP) portfolio.

The Company has now completed preliminary laboratory work leading to the identification of OX Pzero platform technical modifications that alter the release properties and enable faster release of the NSAID. As a result of this work, the company has just filed a national application for a new patent in the UK with international filings to be expanded over the next two years as the application progresses, significantly strengthening the IP portfolio for its OXP zero technology platform.

The Company will be now progressing to conduct UK based Phase I exploratory pharmacokinetic (PK) clinical studies to validate the in vivo performance of these technology improvements, focusing first on its lead compound OXP zero Ibuprofen.  The OXP zero Ibuprofen study will be split into three parts and will assess the PK profiles both at over-the-counter (OTC) and prescription (Rx) strength doses of standard ibuprofen against OXP zero Ibuprofen and the lead technology modifications identified. Regulatory and Ethics submissions have been made for this study and dosing is expected to start early in 2017. In addition, pre-clinical evaluation of these technology modifications is ongoing using an innovative gastric mucosal cell model at the University of Newcastle to assess the effect of these technology modifications on gastric mucosal damage.

In parallel to this technical and clinical work, the Company is seeking clarity on the regulatory pathway for OTC and Rx OXP zero NSAID products. The Company is now seeking advice from the US Food and Drug Administration (FDA) on the development pathway for the OTC and Rx OXP zero Ibuprofen programmes. Pre-IND meeting requests have been submitted to the FDA for both the OTC and Rx variants; the Company has assembled a team of highly-experienced US and EU consultants to assist with these meetings which are expected to take place early in 2017. Obtaining clarity from the FDA on the regulatory pathway will be a major milestone to further facilitate partnering discussions for the key US market.

Other programmes

While the focus has been OXP zero NSAIDs, the company also carried out development work to further its cardiovascular pipeline.

Following extensive process development work, OXP zero Aspirin has been successfully manufactured at laboratory scale.  As the material produced by this process has not attained the required stability profile, a decision has been taken not to progress this programme further at this time, said the company and continued:

In our statins portfolio, development of a new colon-targeted formulation of atorvastatin is ongoing. The aim of this programme is to reduce the degree of cytochrome P450 metabolism in the upper GI tract, thereby reducing the formation of degradation products known to cause statin related side effects such as myalgia (muscle pain). A new formulation development and manufacturing contract facility has been appointed and development of a new salt form of atorvastatin with anticipated improved acid stability is ongoing.

Funding

Oxford Pharmascience remains well-funded to complete this next stage of work on clinical development and the regulatory pathway for its OXP zero products, as well as the development work on atorvastatin, with cash balances as at 31 October 2016 of circa £22.6 million.

Commenting on the progress, CEO Marcelo Bravo said:

“In parallel to the ongoing commercial partnering activities, we are pleased to see OXP zero Ibuprofen going back into the clinic and our OXP zero NSAIDs IP protection being strengthened.  We look forward to receiving advice from the FDA on our over-the-counter and prescription OXP zero Ibuprofenproduct development strategies.”

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