York Pharma PLC Release: Pre-IND Conference Requested to Enable International Phase IIb Study for Sabarep™
The Company confirms that following earlier positive results generated in a human study to validate the effects on the skin barrier and to confirm the final dosage composition of the product, plans are now progressing towards an international Phase IIb clinical programme. The manufacture and testing of product supplies for these clinical studies are underway.
Sabarep™ is intended to be a global product and in parallel with the development advances in Europe, the Company has received new advice from regulatory experts that a simplified clinical programme for Sabarep™ could be adopted in the USA. Therefore, York Pharma has today requested a pre-IND (Investigational New Drug application) conference with the FDA to confirm that the Company’s planned programme design meets the requirements for building a scientific and clinical dossier which could lead to regulatory approval and commercialisation of Sabarep™ in the USA.
A meeting has already been held with the UK regulator (MHRA) to discuss the pre-clinical and clinical results generated to date with Sabarep™ and to finalise the requirements for the remainder of its development programme prior to the regulatory submission for Marketing Authorisations in Europe.
Terry Sadler, Chief Executive of York Pharma, commented:
“This development could simplify significantly the international approval of Sabarep™ and is the third product in York’s development pipeline to enter international clinical studies. Although up to 25% of children suffer from atopic eczema there are limited treatment choices available and, as a result, there is a clear medical need for a non-steroidal treatment which can be used safely and effectively in children.
York Pharma is now becoming a world leader in understanding how a damaged skin barrier can trigger a wide range of allergic reactions and diseases; the prevention of which will have a major impact on patient well-being and costs to health service providers."
For further information please contact:
York Pharma plc Tel: +44 (0)870 067 2563 Terry Sadler, Chief Executive Officer
Financial Dynamics Tel: +44 (0)207 831 3113 David Yates Ben Brewerton Emma Thompson
Notes to editors:
About Atopic eczema
Atopic eczema (synonym atopic dermatitis) is a disease that affects up to 25% of children and can cause enormous suffering at a crucial time in their development. The child’s skin becomes dry, red and itchy, causing relentless scratching. It has been suggested that atopic eczema has a greater impact on a child (and the family) than diabetes mellitus. (Su JC, Kemp AS, Varigos GA and Nolan TM, Archives of Disease in Childhood. 1997:76; 159-162)
Eczema is a disease associated with the loss in structural integrity of the skin, thereby increasing the risk of exposure to environmental allergens and ‘superallergens’ responsible for chronic atopic diseases such as eczema, asthma and allergic rhinitis (hayfever).
There has been increasing scientific data published over the past five years, indicating that breakdown of the skin barrier is a primary event in the development of atopic eczema. York’s clinical and scientific team has demonstrated that a major contributor to the development of atopic eczema is a genetic predisposition to a defective skin barrier. The defective skin barrier arises because of increased production or activity of proteolytic enzymes, proteases, in the skin. These proteases break down the skin barrier, allowing the penetration of irritants and allergens that trigger a flare of eczema.
The major current medical need is for a new (non-steroidal) class of product to restore the normal skin barrier and to reduce the incidence of flares of eczema. Sabarep™, York Pharma’s Skin Protease Inhibitor formulation is intended to fulfill this need and is potentially a major advance in the treatment of diseases such as atopic eczema.
This loss of skin integrity is brought about by structural adhesion proteins which have become mis-regulated creating a dysfunctional (leaky) barrier, sometimes with an increased cellular cycle which culminates in a thinning of the skin barrier, thus more easily allowing the ingress of environmental allergens which can trigger flares of eczema. Sabarep™ is intended to interrupt this chain of events and create a repair of the skin barrier thereby restoring the skin barrier to its normal protective function.
About Sabarep™ Sabarep™ is a new treatment for eczema and related diseases of the skin. Sabarep™ is the first product arising from York Pharma’s skin barrier discovery platform and is a novel, patented formulation which is able to modulate skin protease activity, to provide the conditions for the repair and maintenance of a healthy skin barrier.
About York Pharma plc York Pharma is an AIM-listed strategic acquirer, developer and marketer of pharmaceutical products in the field of dermatology. Its portfolio now embraces skin diseases that make up approximately 87% of the global $10.6bn dermatology market. For further information, please go to www.yorkpharma.com.