On December 14, 2015 Bird Rock Bio, Inc., a clinical stage biopharmaceutical company, reported its corporate name change from RuiYi, Inc. to Bird Rock Bio (Press release, Bird Rock Bio, DEC 14, 2015, View Source [SID1234515802]).
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"With the advancement of gerilimzumab into Phase 2 for rheumatoid arthritis (RA) and RYI-018 into Phase 1 for non-alcoholic fibrotic liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) in 2016, our organization has shifted dramatically from discovery operations in Shanghai to global clinical development for novel antibody therapeutics targeting large unmet medical needs," said Paul Grayson, CEO. "We anticipate an exciting year of milestones for both of our highly differentiated antibodies and the new name reflects the shift and progress."
Backed by leading biotechnology venture investors, Bird Rock Bio’s strategy leverages biologic targets with substantial human proof of mechanism for the development of best in class molecules with strong clinical and commercial differentiation. RYI-018 is a first in class inverse agonist antibody to the CB1 receptor with anticipated clinical differentiation associated with an enhanced safety profile and gerilimzumab is a novel anti-IL-6 antibody with potential commercial differentiation as a disruptive, cost effective treatment.
Previous small molecule inverse agonists to the CB1 receptor demonstrated significant benefits in inflammation, metabolism and fibrosis (the principle contributors to NAFLD and NASH), however, these small molecule drugs had potential risk of severe CNS side effects. RYI-018 is the only known CB1 inverse agonist antibody and has demonstrated, pre-clinically, distribution to all peripheral tissues without penetration of the brain. As such, RYI-018 possesses differentiated and potentially compelling product potential for large unserved markets such as NASH. The Company is advancing RYI-018 through IND enablement and anticipates Phase 1 to initiate 2H 2016.
Gerilimzumab is a novel monoclonal antibody that is directed against the IL-6 cytokine, for the treatment of autoimmune disorders, including RA. Gerilimzumab has an ideal product profile, demonstrating in preclinical studies to have the highest known potency amongst the anti-IL-6 cytokine class and in a Phase 1 clinical trial in healthy volunteers to have an extended blood half-life, which is anticipated to support small volume dosing Bird Rock Bio once every eight weeks. This would enable high patient convenience and lowest pricing, which are compelling product features for a chronic therapy to increasingly cost-sensitive healthcare systems globally.
Bird Rock Bio believes gerilimzumab has the potential to effectively compete in the $35 billion global biologic market for rheumatoid arthritis by not only treating the large number of anti-TNF refractory patients but also becoming a front line treatment for moderate and severe patients. The Company expects to submit for its Phase 2 clinical trial in Brazil, a country with more than 1 million biologic naïve RA patients in 1H 2016