Autoimmune Disorders & Transplant Rejection: Opportunities for the Drug Development Sector

Affecting as many as 5% of the population, autoimmune disease represents a major clinical problem. Ranking alongside other major conditions such as type II diabetes, in terms of prevalence this group of diseases includes a large number of different conditions of varying prevalence, associated morbidity and disability, and available clinical options. Despite the fragmentation of this market it has proved lucrative for the drug development sector with the emergence of TNF blockers, therapeutics that have now been approved for multiple indications in this market. Global sales of TNF blockers now exceed $5 billion.

Despite the success of the TNF blockers for the treatment of rheumatic diseases, inflammatory bowel disease and psoriasis, this class is rarely completely effective in these indications and some patients are unresponsive to treatment. Moreover other autoimmune diseases that have not benefited from the development of TNF blockers remain unmet markets served by the same therapeutics employed over thirty years ago. The autoimmune disease arena overlaps with the transplant sector.

Although only 0.01% of the population are transplant recipients this field represents a major focus of the drug discovery sector. Drawing less revenue than the TNF blockers, transplant therapeutics nonetheless generate global annual sales worth $2.7 billion even before figures for Cyclosporine are included. Advances over the past decades have led to improved long-term survival of patients although improvements are still required especially for the treatment of lung and intestinal transplants, and for the induction of tolerance in order to obviate life-long immunosupression.

Autoimmune Disorders & Transplant Rejection: Opportunities for the Drug Development Sector represents the most in depth analysis of these areas published for many years. Targeted towards all involved in drug development this report overviews the prevalence of the autoimmune diseases and identifies those that we believe should be prioritized by the drug development sector. Diseases highlighted are:

> Psoriasis

> Graves’ disease

> Rheumatoid arthritis

> IBD

> Type I diabetes

> Multiple sclerosis

> Lupus.

While TNF blockers target the innate immune system, considerable opportunities exist for the development of therapeutics that target T-cells. Each of these autoimmune diseases has a major T-cell component and this report describes the immunology of these indications with an emphasis on T-cell contribution. Recent research has revealed a large number of T-cell molecular targets but only a few candidates for these targets have survived late stage development. This relatively barren pipeline offers significant opportunities however selecting the most appropriate target is critical for drug development activities. This report provides a detailed evaluation of:

> CD80/86:CTLA4/CD28

> Recently identified B7 molecules: PD-L1 (B7-H1), PD-L2 (B7-DC), B7-H3 & B7-H4

> CD40:CD154

> New TNFR family members including OX-40 (CD134) and 4-BB (CD137).

> ICOS:ICOS-L

> Adhesion molecules

Autoimmune Disorders & Transplant Rejection characterizes each of these molecular targets and provides a detailed proof of concept discussion allowing the reader to identify which targets are likely to provide most benefit for the selected indications. The report also provides a full evaluation of regulatory T-cells, a cell type that represents a major target for candidate treatments of both autoimmune disease and transplant rejection. Finally we identify some very novel and unexploited opportunities within this field including the possibility of targeting ICAM-1 to reverse established diabetes and the use of estrogen ligands to induce tolerance. The report provides in depth evaluation of preclinical and clinical data, describes the pipeline for autoimmune candidates that target T-cells, and profiles drugs in development or on the market. Profiles include sales figures for each marketed product.

The report concludes with LeadDiscovery’s analysis of T-cell therapeutics and suggests the most appropriate for further development. Some promising candidates have suffered problems in the clinic, notably the CD154 blockers and this report highlights these problems and strategies to overcome them. Other molecules such as CTLA4-Ig (eg Abatacept & Belatacept) have shown promising activity however there is room for optimization. We discuss the aims of such optimization.

In short this report represents a key tool for all involved in the autoimmune and transplant sector and offers detailed insight to those wishing to be involved in the development of next generation therapeutics.

Publication date: December, 2005

Page Count: 83 pages (not including references; sample pages) - note we use single space 10 font formatting. We do not bump up pages counts with double spacing large font sets etc!!)

Price: £$2250 (5 user license); $3150 (site license); $4500 (global license)
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