Nura Bio Initiates Phase I Clinical Trial for its Oral, Brain-Penetrant SARM1 Inhibitor, NB-4746

- NB-4746 is being developed as a neuroprotective therapy for neurological diseases

- Milestone marks Nura Bio’s transition to a clinical-stage company

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Nura Bio, Inc. (Nura Bio), a biopharmaceutical company developing neuroprotective, small molecule therapies for the treatment of debilitating neurological diseases, today announced the initiation of the Phase 1 clinical trial of its SARM1 inhibitor, NB-4746.

NB-4746 is believed to be a first-in-class, oral, brain-penetrant, neuroprotective SARM1 inhibitor with broad therapeutic potential across diseases of the central, peripheral, and ocular nervous systems. NB-4746 confers significant structural and functional protection in several preclinical disease models including Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Traumatic Brain Injury (TBI), and Chemotherapy-Induced Peripheral Neuropathy (CIPN). In preclinical models, NB-4746 significantly reduced and in some cases prevented, an increase in levels of the axonal injury-dependent, disease-associated biomarker neurofilament light (NfL).

“We are excited about the potential of NB-4746,” said David Lau, PhD, Senior Vice President, Development Sciences, 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.”

The Phase 1 clinical trial is a randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study to assess the safety, tolerability, and pharmacokinetics of NB-4746 in healthy volunteers.

“The initiation of the Phase 1 trial of NB-4746 marks Nura Bio’s transition to a clinical-stage company,” said Shilpa Sambashivan, PhD, Chief Scientific Officer, Nura Bio. “With our strong scientific foundation and dedicated team, we are rapidly progressing NB-4746 through early development. We also continue advancing additional molecules through our pre-clinical pipeline, with the goal of delivering novel and potentially life-changing neuroprotective medicines.”

About NB-4746

NB-4746 is the lead asset in Nura Bio’s small molecule pipeline. NB-4746 targets SARM1, a neuronally enriched NAD hydrolase that has emerged as an important axon-intrinsic metabolic sensor and central driver of axon degeneration. Axon degeneration is an early hallmark of several neurological diseases. Halting axon degeneration early can confer significant structural and functional neuroprotection and has tremendous potential in the treatment of several neurological diseases.

About Nura Bio

Nura Bio, Inc. (Nura Bio) is a clinical-stage biopharmaceutical company developing neuroprotective therapies for the treatment of a broad range of neurological diseases. Nura Bio’s research and early development small molecule pipeline spans discovery through Phase 1. Nura Bio’s efforts are focused on developing therapies that halt axon degeneration and/or modulate microglial responses to degeneration and injury, with the goal of conferring neuroprotection, across diseases of the central, peripheral, and ocular nervous systems.

For more information, visit www.nurabio.com.