New patent filed as York advance eczema treatment
York Pharma plc, which is developing pharmaceutical products for skin care, announces progress in the development of Sabarep™, York's patented treatment for atopic eczema and related diseases of the skin.Results from human subjects identify the optimal composition of this multi-component product. The company has also discovered additional novelty during the course of these studies and has filed a new patent to enhance further its strong intellectual property position in the area of skin protease inhibition.
The functional mechanistic studies of Phase II design (vehicle and placebo controlled) generated data from 114 human subjects, involving 149 tests on these subjects, with 760 skin sites tested.
The skin was damaged in a clinically controlled manner to model the defective barrier in eczema. Subsequent repair was monitored during treatment. These investigations were designed to optimise the composition of Sabarep.
Using biophysical and clinical assessments following four-day treatment periods, initial preparations containing single ingredients improved skin barrier function by 22 per cent, compared to baseline. Subsequent development has led to an optimised, multi-component Sabarep formulation achieving a 67 per cent improvement over baseline. These developments have produced new discoveries leading to an additional patent filing, further strengthening the Company’s position in this field.
Furthermore, earlier this month, the Company held a meeting with the UK medicines regulator (MHRA) to review the results generated to date with Sabarep and to agree the requirements for the remainder of its development programme prior to the regulatory submission for a Marketing Authorisation. The Company is pleased with the outcome of this meeting, which has clarified the remaining stages of development of this new class of therapy.
Terry Sadler, York Pharma’s CEO commented: “The progress the Company has achieved to date with Sabarep is impressive and the three events: the progress towards the final formulation; the filing of a new patent and the meeting with the regulator, now allow the Company to move into the remainder of the clinical development programme with clarity and confidence.
“York Pharma is now a world leader in the fundamental understanding of the skin barrier. A dysfunctional barrier plays a primary role in a cascade that results in a wide range of allergic reactions and diseases such as atopic eczema. The restoration of skin barrier function is expected to have a major impact on patient well-being and a cost-benefit to health service providers."