On May 28th, biopharmaceutical company Bird Rock Bio filed an IND application to perform a Phase II clinical study to determine the efficacy and tolerability of nimacimab. The company hopes to use nimacimab to treat patients with renal diseases. Read the full release on BioSpace.

Bird Rock Bio’s IND Application

An Investigational New Drug (IND) application represents the start of the drug review process. The sponsor submits the application to the FDA, who explains the IND process more in depth on their website. According to the FDA, a drug therapy needs to be approved before it can cross state lines. So:

because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA.

In this case, Bird Rock Bio is looking to perform a Phase II clinical study on the impact of nimacimab for patients with one of three renal diseases:

• Diabetic kidney disease
• Focal segmental glomerulosclerosis (FSGS)
• Immunoglobin A (IgA nepropathy)

Nimacimab: A Potential Treatment for Renal Diseases

So what exactly is nimacimab? Well, it is described as a negative-allosteric modulating antibody. Let’s break this down a little:

• Allosteric: defined by Merriam-Webster as “of, relating to, undergoing, or being a change in the shape and activity of a protein (such as an enzyme) that results from combination with another substance at a point other than the chemically active site.”
• Allosteric modulators: allosteric modulators, then, bind to a certain receptor in the body and change the way it acts or responds to stimuli.

So, a negative-allosteric modulator helps to reduce the efficacy of certain receptors, reducing negative responses. In this case, nimacimab targets the cannabinoid 1 (CB1) receptor. Cannabinoid receptors can play a role in renal diseases by increasing inflammation and fibrosis, therefore creating more damage.

The company discovered nimacimab through their proprietary iCAPS platform. The platform searches a database of G-protein coupled receptors (GPCRs) to identify potential modulators to treat patients with unmet needs. Currently, nimacimab is the first drug therapy of its kind to enter into clinical trials. Bird Rock Bio owns worldwide rights.

Phase I Clinical Trial

The completed Phase 1B study showed nimacimab to be safe, effective, and tolerable for patients with diabetes. There were no serious adverse reactions.

Additionally, Bird Rock Bio manufactured 1,000 liters of the drug; showcased its stability for at least 1 year; and conducted a 6-month toxicology study. Now, the Phase II study would examine nimacimab in relation to renal diseases.

Renal Diseases

Diabetic Kidney Disease

Diabetic kidney disease is a type of renal disease caused by diabetes. About 25% of patients with diabetes later develop kidney disease. Normally, your kidneys help filter waste out of your blood, which you excrete through urine. But when the kidneys are damaged, waste accumulates, causing health issues. In patients with diabetes, this results from high blood sugar or high blood pressure. Many people are asymptomatic, particularly during earlier stages of the disease. However, if or when symptoms appear, they may include:

• Fatigue
• Nausea, vomiting, and appetite loss
• Shortness of breath
• Difficulty with memory and concentration
• Eye, hand, ankle, and feet inflammation
• Increased need to use the bathroom

Learn more about diabetic kidney disease.

Focal Segmental Glomerulosclerosis (FSGS)

One of the rare renal diseases is focal segmental glomerulosclerosis (FSGS), which occurs when scar tissue forms on glomeruli. Each kidney has around 1 million glomeruli, or little clusters of blood vessels that help filter waste. These little structures leave protein in the blood while filtering out (what will become) urine. But proteins enter the urine when glomeruli become damaged.

There are 3 types of FSGS:

• Primary, which has no known cause.
• Secondary, which is often caused by viruses or blood disorders, autoimmune disorders, sleep apnea, obesity, kidney reflux, or kidney defects.
• Genetic (familial), which is caused by genetic mutations.

Symptoms include high blood pressure, high cholesterol and creatine, protein in the urine, and optic, hand, feet, and abdominal swelling. Learn more about FSGS.

Immunoglobin A (IgA) Nephropathy

One of the final renal diseases we’ll be exploring is immunoglobulin A (IgA) nephropathy, or Berger’s disease. This chronic kidney disease occurs when the antibody immunoglobulin A accumulates in the kidneys. Normally, IgA helps fight foreign invaders. But when it accumulates, it causes inflammation and tissue damage. Much like FSGS, IgA nephropathy damages glomeruli. It often occurs after an upper respiratory or gastrointestinal infection. IgA nephropathy also impacts males more than females.

While patients may be asymptomatic for years, symptoms (upon appearance) include:

• Excess blood or protein in the urine
• Drowsiness
• Swelling of the hands and feet
• Pain in the groin and back
• High blood pressure
• Kidney failure

Learn more about IgA nephropathy.