La Jolla, Calif., September 13, 2018 – Bird Rock Bio, Inc., a clinical stage biopharmaceutical company, announced today that it has successfully completed its final patient visit in the Phase Ib multiple ascending dose trial in patients with non-alcoholic fatty liver disease (NAFLD) and diabetes or pre-diabetes. Nimacimab, also known as RYI-018 or JNJ-2463, a negative-allosteric modulating antibody targeting the cannabinoid 1 receptor, was administered in three sequential escalating dose cohorts of 28 patients each, and was conducted at eight clinical trial facilities in the United States, Canada, and Australia. Notably, 81 of the 84 patients randomized completed the trial, and there were no serious adverse events (SAEs) or early terminations due to adverse events reported.
“The primary objectives of the multiple ascending dose portion of the Phase I clinical trial are to evaluate safety, tolerability, and pharmacokinetics of nimacimab in patients,” said Paul Grayson, President and CEO of Bird Rock Bio. “Additionally, we are assessing the effects of nimacimab on numerous biomarkers related to non-alcoholic liver disease and kidney disease.”
“Completion of the final patient visit in our clinical study is an important milestone in our development plan. While the results of the study remain blinded, we are encouraged by the fact that there were no serious adverse events or early terminations due to adverse events reported in the study,” said Alan Glicklich, Bird Rock Bio’s Chief Medical Officer. “Each cohort of the trial included four weekly doses followed by safety and biomarker assessment out to 67 days post first dose.”
Study results from the clinical trial are anticipated prior to the American Society of Nephrology’s “Kidney Week” in October in San Diego and AASLD’s The Liver Meeting® 2018 in November in San Francisco.
Discovered internally through Bird Rock Bio’s proprietary iCAPS platform, nimacimab is the first and only known negative-allosteric modulating antibody to the CB1 receptor to be in clinical trials. Nimacimab is a multi-modal therapeutic candidate with fibrotic, inflammatory and metabolic mechanisms of action. This provides for the opportunity for nimacimab to have significant potential across a broad range of fibrotic and metabolic diseases including large unmet medical conditions such as NASH and diabetic nephropathy.
Bird Rock Bio’s iCAPS platform, the leading GPCR allosteric antibody drug discovery platform, can isolate and present functional GPCRs in the correct confirmation to identify selective monoclonal antibody allosteric modulators. GPCRs are a valuable class of drug targets but have been largely unexplored in antibody discovery because of the difficulty in isolating GPCRs in the correct conformation and functional form.
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