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RESEARCH & TECHNOLOGY

Lycera’s novel approach to developing selective oral immunomodulators and disruptive technologies positively position the company to have a significant impact on high unmet-need autoimmune diseases. Lycera has brought together leaders and scientists who represent the best of their individual fields to build a team with the unique credentials to transform the direction of drug development and treatment for autoimmune diseases.

Lycera is focused on developing oral small-molecule medicines to treat autoimmune diseases having identified two promising novel autoimmune pathways and is working to identify and investigate other promising leads. Both the Bioenergetics and Th17 pathways have been validated in preclinical/clinical studies. We believe that drugs developed from these platforms will have the potential for first-in-class oral efficacy without the safety and tolerability issues or the burdensome injections associated with today’s biologic therapies.

Bioenergetics

Lycera’s proprietary technology platform is focused on the emerging area of cellular bioenergetics to selectively target and silence pathologically activated lymphocytes without global immunosuppression, thereby keeping the healthy immune cells intact. Cellular bioenergetics is a field of biology focused on studying how energy in the form of ATP is made and utilized in living systems.

Lycera’s lead research program, the Bioenergetics program, originated from the lab of the company’s founder and chief scientific officer Gary D. Glick, Ph.D., at the University of Michigan. In preclinical studies, modulating the ATPase within the mitochondria of pathologically activated lymphocytes has demonstrated efficacy with no major toxicities or effects on antibody or DTH responses in mice. Testing has been conducted in preclinical models of lupus, rheumatoid arthritis, psoriasis, graft-vs.-host disease and other medical conditions. The mechanism has been supported by extensive published and unpublished work over the past eight years and has generated multiple potential drug candidates. The company is on track to be in the clinic in 2011 with its first small-molecule oral therapy candidate.

Th17

Lycera has developed a proprietary lead program that targets Th17 cells, key mediators of inflammation, through the inhibition of ROR-gamma, a member of the highly druggable nuclear receptor super-family. Th17 cells secrete pro-inflammatory cytokines (including IL-17A, IL-17F, IL-21 and IL-22) and express IL-23 receptor and chemokine receptor CCR6, which play important roles in autoimmune disease. Targeting Th17 cell differentiation by blocking production of pro-inflammatory cytokines, IL-23R and CCR6 can be achieved by inhibiting the upstream master regulator ROR-gamma, which controls the production of IL-17 and other related proinflammatory cytokines.