Experimental MS therapy NB-4746 to be tested in healthy volunteers

Nura Bio has launched a Phase 1 clinical trial evaluating NB-4746, its investigational treatment for multiple sclerosis (MS) and several other neurological conditions, in healthy volunteers.

The trial’s participants will be randomly assigned to receive single and multiple doses of NB-4746 or a placebo. The goal is to evaluate the safety, tolerability, and pharmacokinetics of the small molecule before it can be moved to clinical trials in people with neurological diseases. Pharmacokinetics refers to the movement of a drug into, through, and out of the body.

The company believes NB-4746 could have a broad application in diseases of the nervous system. In addition to MS, the therapy has shown the ability to reduce signs of nerve damage in models of amyotrophic lateral sclerosis, traumatic brain injury, and chemotherapy-induced peripheral neuropathy.

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Phase 1 trial ‘marks Nura Bio’s transition to a clinical-stage company’

“The initiation of the Phase 1 trial of NB-4746 marks Nura Bio’s transition to a clinical-stage company,” Shilpa Sambashivan, PhD, chief scientific officer at Nura Bio, said in a company press release. “With our strong scientific foundation and dedicated team, we are rapidly progressing NB-4746 through early development.”

MS occurs when the immune system mistakenly attacks myelin, the protective coating around nerve fibers that helps them send electric signals efficiently. This leads to inflammation, further damaging the myelin sheath and nerve cells.

NB-4746 is an oral small molecule that blocks SARM1, an enzyme highly produced by nerve cells that is activated upon injury and contributes to axonal degeneration.

Axonal degeneration happens in the deterioration and loss of function of the axon, the long wire-like projections of nerve cells that sends signals to other neurons or to muscles. It occurs in MS as a result of damage to the protective coating of these nerve fibers, and is associated with sensory, motor, and cognitive symptoms.

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Clinical trials in patients expected in 2024

By inhibiting SARM1, NB-4746 has been shown to protect nerve cells from damage in animal and cell models of disease, preserving the structure and function of these cells. It also lowered the levels of neurofilament light chain (NfL), a marker of nerve cell damage.

The molecule has the ability to cross the blood-brain barrier, a highly selective barrier that controls which substances can travel from the blood into the brain. Crossing this barrier is often a challenge for drugs that aim to target the brain and spinal cord.

“We are excited about the potential of NB-4746,” said David Lau, PhD, senior vice president of development sciences at Nura Bio. “We expect to enter clinical trials in a patient population in 2024, to evaluate the impact of NB-4746 on axonal injury and NfL levels.”