Bird Rock Bio completed its final patient visit in a phase 1b ascending dose trial of nimacimab for treating patients with nonalcoholic fatty liver disease and diabetes or pre-diabetes, according to a press release.
“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,” Paul Grayson, president and CEO of Bird Rock Bio, said in the release. “Additionally, we are assessing the effects of nimacimab on numerous biomarkers related to nonalcoholic liver disease and kidney disease.”
Nimacimab, also known as RYI-018 or JNJ-2463, is a negative-allosteric modulating antibody designed to target the cannabinoid 1 receptor. The phase 1b study comprised three sequential escalating dose cohorts of 28 patients each. Eighty-one of the 84 patients completed the trial.
The researchers reported no serious adverse events or early terminations due to adverse events.
“Completion of the final patient visit in our clinical study is an important milestone in our development plan,” Alan Glicklich, chief medical officer of Bird Rock Bio, said in the release. “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.”
Bird Rock Bio anticipates completed study results prior to the American Society of Nephrology’s Kidney Week 2018 meeting in San Diego, California, and AASLD’s The Liver Meeting 2018 in San Francisco, California.