LTS and LEO Pharma have announced that the companies will begin a clinical trial to test microarray patches that are designed as local intradermal treatments of psoriasis.
The study will start in April 2019 with expected completion later this year. The aim of the study is to document safety and efficacy in patients.
Also known as a microneedle patch, a microarray patch is a polymeric, microscopic array that delivers encapsulated drugs by perforating the outer stratum corneum with numerous microneedles. The needles are biodegradable and will dissolve as they release the drug in the skin.
This is the first time that microarray patch technology has been applied to psoriasis, representing a novel dosage form with several potential benefits for patients. The microarray patch enables slow release of the drug (betamethasone and calcipotriol), which means that treatment frequency can potentially be reduced from one or more times daily to once weekly. Furthermore the patch may reduce or potentially eliminate the need for application of topicals such as ointments.
Application of the patch is precise due to the small size of the microneedles, ensuring that only affected skin is treated.
The microarray patch for psoriasis has been developed jointly between LEO Pharma and LTS’ laboratories and has good manufacturing practice (GMP) status. The project is the first result of a partnership agreement which the two companies entered in 2016.
Head of LTS’ innovative injection systems unit Stefan Henke said: “After a successful preclinical development in the last two years, initiating a human study in cooperation with LEO Pharma is the next major milestone. Our Micro Array Patch (MAP) platform allows the active ingredient to be released directly into the skin. MAP innovation is driven by a productive and constructive cooperation using core competences of LEO Pharma and LTS.”
Executive vice-president of LEO Pharma research and development (R&D) Kim Kjøller said: “Our alliance with LTS is a great example of LEO Pharma’s innovative approach to psoriasis treatment and how we collaborate to improve and extend what’s possible for the benefit of patients. The microarray patch represents a new treatment method, which we believe has the potential to improve both treatment compliance and convenience, thus helping even more patients achieve healthy skin.”
About LEO Pharma
LEO Pharma is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of R&D to advance the science of dermatology, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 5,700 people, serving 80 million patients in 130 countries. In 2017, the company generated net sales of €1.4bn.