Oxford Pharmascience Group has 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, said the company in its press release issued on Tuesday.
The company said 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. 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.
At a same time Oxford Pharmascience has submitted pre-IND (Initial New Drug) packages to the FDA for both OXPzero Ibuprofen OTC and Rx programmes. The FDA said that its formal feedback will be provided during Q1 2017 in written format only.
The company has also 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, 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.
The company continues in dialogue with prospective partners regarding these developments with a view to commercializing its OXPzero assets. As at 31 December 2016, the company had net cash of circa £21.9 million.
CEO Marcelo Bravo commented:
“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.”