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news.Bird Rock Bio has filed an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a phase 2 clinical study of nimacimab, also known as RYI-018, in patients with one of the following renal diseases: diabetic kidney disease, focal segmental glomerulosclerosis (FSGS), or immunoglobulin A (IgA) nephropathy.
The US FDA’s Center for Drug Evaluation and Research. (Credit: The U.S. Food and Drug Administration)
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Nimacimab is a negative-allosteric modulating antibody targeting the cannabinoid 1 (CB1) receptor, which has a known association in renal fibrosis and inflammation. Bird Rock Bio owns the worldwide rights to nimacimab, with patents issued in the U.S. and other territories, including claims to cannabinoid 1 receptor antibodies with inverse agonist function.
The safety and tolerability assessments from the completed phase 1b study in patients with diabetes or prediabetes demonstrated no serious adverse events (SAEs), no early terminations of treatment due to adverse events, and no adverse events of concern occurring in a dose-dependent manner. The pharmacokinetic assessment showed a half-life of approximately three weeks, potentially allowing for monthly dosing. Some encouraging trends were observed in the exploratory biomarkers after the three-week dosing period.
“We are looking forward to the evaluation of nimacimab as a potential treatment for renal diseases with significant unmet need,” said Paul Grayson, the Company’s President and CEO. “Preclinical data suggest that CB1 antagonism with nimacimab may significantly improve renal function and has the potential to provide a first-in-class treatment option in several indications.”
In parallel to carrying out the clinical trial, the Company has successfully completed drug manufacturing at a 1,000-liter scale, demonstrated stability of the drug product in pre-filled syringes for more than 12 months and has completed a 26-week toxicology study with no significant findings.
“The filling of this IND represents the culmination of multiple preparatory activities that position nimacimab for a large value inflection as the Company pursues strategic options for the conduct of the study,” said Alyssa Lochbaum, CFO, Bird Rock Bio.
Source: Company Press Release
