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Oxford, which specialises in reformulating drugs to make them better, safer and easier to take, said the results of the trial indicated that OXP001 caused significantly less gastrointestinal irritation in comparison to Ibuprofen.
The company said the results allow the company to push on with confidence to the phase III clinical trial, where the drug will be tested on a large number of people and compared to the current standard treatment, though a bit of tweaking to the tablet formulation will be required.
The pharmacokinetic data obtained from the study indicated that while 65% of OXP001 subjects had comparable absorption to the Brufen (Ibuprofen) tablet, OXP001 achieved a smaller average dose of Ibuprofen absorbed (around 76%). An average in the 80-125% range is required to achieve bioequivalence.
"Oxford Pharmascience is very encouraged by the positive results of this proof of concept study in humans showing significant reduction in gastrointestinal irritation of OXP001 compared to Ibuprofen,” said Marcelo Bravo, Oxford’s chief executive officer.
Dr Stuart Mair, medical director at Quotient Clinical and the principal investigator in the trial said the results are “potentially meaningful in a clinical context, representing an improved safety profile”.
NSAIDs are one of the most commonly consumed types of drug, with an estimated 30mln people worldwide taking them on a daily basis; however, there are well-documented gastrointestinal side-effects, such as erosions, bleeding and ulcers, and the OXP001 formulation seeks to reduce or eliminate these.
House broker N+1 Singer said the result is extremely positive for the prospect of OXP001 and the company’s OXPxero technology.
“OXP001 and OXPzero could potentially offer patients NSAIDs with an improved safety profile,” the broker said.
“We look forward to data on the optimised OXP001 tablet, expected over the coming months, and the subsequent commencement of larger scale pivotal trials,” N+1 Singer said.
Share price reaction was positive, with the shares up 6.2% in mid-morning trading at 4.78p. Year-to-date, the shares are up nearly 27%.