Companies to Focus on Developing Drugs that Inhibit RORγt
PLYMOUTH, Mich. – March 3, 2011 – Lycera Corporation, a biopharmaceutical company pioneering innovative approaches to developing novel oral medicines to treat autoimmune diseases, today announced that it has entered into an exclusive research collaboration with Merck to discover, develop and commercialize small molecules that target T-helper 17 (Th17) cells, key mediators of inflammation. The collaboration will focus on developing drug candidates that have the potential to treat major autoimmune diseases such as rheumatoid arthritis, psoriasis, inflammatory bowel disease and multiple sclerosis.
“We are delighted to be working with Merck, which brings industry leading expertise in drug discovery, development and commercialization to this collaboration,” said Gary D. Glick, Ph.D., Lycera founder and chief scientific officer. “This joint partnership is a significant validation of Lycera’s discovery capabilities and our Th17 program, and enables us to expand the scope of our research in this promising area to expedite our discovery efforts as well as our timeline to enter the clinic.”
Under the terms of the agreement, Lycera will collaborate with Merck, through an affiliate, on discovery efforts and preclinical development of candidates targeting the retinoic acid related orphan receptor (RORγt). Merck is responsible for clinical development and will have worldwide marketing and commercialization rights to any resulting products, subject to a profit share option in the U.S. retained by Lycera to all products resulting from the collaboration. Lycera will receive $12 million in upfront cash payments, significant committed research funding, and is eligible to receive up to $295 million in research, development and regulatory milestone payments if multiple major indications are approved. Lycera is entitled to up to low double digit tiered royalty payments and sales milestones on global sales from any products that are developed as a result of the collaboration.
“Autoimmune diseases continue to represent a significant unmet medical need globally,” said Don Nicholson, Ph.D., vice president and head of worldwide discovery, Respiratory and Immunology Franchise, Merck Research Laboratories. “Lycera has established a strong reputation for innovation in this area and we look forward to working together to advance this program.”
Th17 cells are characterized by the production of interleukin-17 (IL-17), a highly inflammatory cytokine that plays an important role in the pathogenesis of immune-mediated diseases, including psoriasis, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease (colitis) and asthma. RORγt is the key transcription factor that orchestrates the differentiation of Th17 cells, inducing transcription of the genes encoding IL-17. Mice with RORγt deficient T cells have attenuated disease and lack tissue-infiltrating Th17 cells. Thus, RORγt is a key regulator of immune homeostasis and is a potential therapeutic target for immune diseases. Lycera has developed a proprietary program that targets Th17 cells and has identified novel, potent and specific inhibitors of RORγt that reduce IL-17 production in primary cells and in vivo.
About Autoimmune Diseases
Serious autoimmune diseases are a major and growing public health problem. An autoimmune disorder is a condition that occurs when the immune system mistakenly attacks and destroys healthy body tissue. There are more than 80 different types of autoimmune disorders1, and approximately 50 million Americans, or one in five people, suffer from autoimmune diseases2.
Lycera Corp. is focused on the discovery and development of selective, small-molecule immunomodulators for the treatment of patients with autoimmune diseases such as rheumatoid arthritis, psoriasis and inflammatory bowel disease. Lycera is developing drug candidates that target two novel therapeutic pathways and have the potential for first-in-class oral efficacy without the adverse effects of current standard-of-care antiproliferative and immunosuppressive agents. Lycera is focused on the emerging area of cellular bioenergetics to selectively target and silence pathologically activated cells. The company also has a program targeting the Th17 pathway through the inhibition of RORγt. Lycera’s leadership team and advisors represent the core thought leaders in immunology, inflammation, organ transplantation and kinase biology and are responsible for key advances and discoveries in these fields. Visit www.lycera.com for more information.
1 Medline Plus, http://www.nlm.nih.gov/medlineplus/ency/article/000816.htm.
2 American Autoimmune Related Diseases Association, http://www.aarda.org/q_and_a.php.