Lycera is a private biopharmaceutical company that is developing novel small molecule immunomodulatory medicines for the treatment of autoimmune diseases and cancer. Based on its world-class R&D engine, Lycera is advancing clinical candidates from distinct, yet complementary, areas of research, including immune metabolism, cell signaling, and immune cell differentiation.
In June of 2015, Lycera entered into an exclusive global collaboration with Celgene Corporation to advance Lycera’s proprietary pipeline. As part of the strategic agreement, Celgene obtained the exclusive right to acquire Lycera upon conclusion of the option period or achievement by Lycera of pre-specified clinical milestones. During the option period, Lycera retains full control of its R&D programs.
Lycera’s lead product candidate, a novel oral, gut-directed ATPase modulator, designated LYC-30937-EC, for the treatment of inflammatory bowel disease (IBD), completed a Phase I clinical healthy volunteer study in December of 2015. In August of 2016, Lycera announced the initiation of a Phase 2 randomized, placebo controlled clinical trial for LYC-30937-EC, in patients with ulcerative colitis (UC). In November of 2016, Lycera announced the start of a Phase 2 randomized, double-blind, placebo-controlled parallel group study designed to assess the efficacy and safety of LYC-30937-EC given orally once daily in subjects with moderate psoriasis.
The Company also has a leading position in the development of agonists of RORγ, a master transcription factor, or “master control switch,” with diverse applications in immuno-oncology. In January 2017, Lycera announced the initiation of a Phase 1/2A study designed to find the biologically active or maximum tolerated dose of LYC-55716. Once the recommended Phase 2 dose is determined, the study will be expanded to determine single agent safety and activity in patients with advanced solid tumors. In October 2017, Lycera announced that LYC-55716 was advancing to Phase 2A development. The Phase 2a expansion is expected to enroll approximately 75 patients in 6 tumor cohorts.