Bird Rock Bio announced the Company 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.

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.

Discovered internally through Bird Rock Bio's proprietary iCAPS platform, nimacimab is the first-in-class 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 diabetic kidney disease, FSGS, IgA nephropathy, and non-alcoholic steatohepatitis (NASH).

FSGS is a rare kidney disease, often leading to scarring of the kidney and to end-stage renal disease resulting in the need for dialysis or kidney transplant. Symptoms of FSGS include swelling in parts of the body as well as low levels of albumin in the blood. People with FSGS have elevated levels of protein in their urine. Reducing the amount of protein in the urine is associated with better outcomes for people with FSGS.

IgAN occurs when an infection fighting protein, IgA, gets trapped in the kidney. The inflammation then causes the kidneys to leak blood and protein. Over time kidney function can decline leading to kidney failure.