Development of a skin explant assay as a unique tool for the biotechnology and pharmaceutical industry

Alcyomics Ltd was founded to develop and commercialise novel and highly marketable
solutions for pre-clinical drug testing for inflammatory immune responses and cellular
therapies. Alcyomics' expertise is based around the unique human Skin Explant Assay (SEA) which can be used as a diagnostic tool, to test drugs and compounds for potential allergic or hypersensitivity reactions, including individual responses to stem cells and cellular therapies.
This unique platform is already generating revenues, and is poised for growth.
Animal testing is unpopular with the public and provides only a partial guide to drug responses in man. Drug companies are becoming increasingly reliant upon human tissue- based assays to improve drug development and bring drugs closer to market in a shorter period of time,
ultimately reducing drug R&D costs.
Drugs that prove safe in preclinical animal testing often end up failing when they are first tested in humans, wasting precious time and research funds It is now estimated that the average cost of bringing a new drug to market is $1 bn (€ 0.8bn) and is increasing at a rate of nearly 50 per cent every five to seven years.
Analysts believe that a 10% increase in the speed of drug development can save $100m for
every new drug. The problem is compounded by the lack of effective in vitro models and the
continued reliance on animal testing. Ethical issues aside, the problem with current animal
testing is that it is always still one step away from answering the important question "what will my drug do in man?" This is one of the reasons that 90% of compounds that drug-makers take into human clinical trials ultimately fail to become viable medicines.
The Skin Explant Assay (SEA) offers a unique tool for the biotechnology and pharmaceutical
industry, minimising risk in drug research and reducing animal testing. This non-artificial,
human in vitro assay technology allows the study of primary immune and secondary immune cellular responses in the presence of immunomodulatory drugs i.e. drugs that effect the immune system, such as transplant rejection and autoimmune disease drugs. The assay can also be used to study allogeneic (between 2 individuals) stem cell transplantation, without the need for extensive animal testing.
In the assay white blood cells, lymphocytes, which are cells of the immune system, are
incubated with human skin which allows skin damage to be assessed by histopathology. The skin is graded for histological damage using criteria similar to that used and observed in the clinical setting. The results correlate with systemic disease and have been shown to predict outcome. Alcyomics believe that the SEA will benefit the pre-clinical stage of the drug discovery process; in particular, safety, efficacy and dose studies.
Alcyomics is at present a service provider to SMEs and academic institutions for the preclinical testing of novel immuno-suppressant drugs. This initial customer base provides
confidence that the technology is meeting a need in the huge market for development of
biological and cellular therapeutics. Alcyomics needs to develop the assay for faster
throughput and results' read-out in order to attract large pharmaceutical companies as clients.
We also need to continuously evolve the current assay and research innovative new
technology for IP protection.