As reported within the interim results, Oxford Pharmasciences continues commercialisation discussions for its major assets, OXPzero Ibuprofen and OXPzero Naproxen. In parallel, the company has focused its technical activities on advancing the OXPzero 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 OXPzero 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 OXPzero 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 OXPzero Ibuprofen. The OXPzero 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 OXPzero 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 OXPzero 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 OXPzero 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.
Oxford Pharmascience remains well-funded to complete this next stage of work on clinical development and the regulatory pathway for its OXPzero products, as well as the development work on atorvastatin, with cash balances as at October 31, 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 OXPzero Ibuprofen going back into the clinic and our OXPzero NSAIDs IP protection being strengthened. We look forward to receiving advice from the FDA on our over-the-counter and prescription OXPzero Ibuprofen product development strategies.”
This announcement contains inside information.