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Nura Bio Launches Phase I Clinical Trial for NB-4746: An Oral SARM1 Inhibitor with Blood-Brain Barrier Penetration

Saturday, August 26, 2023

Nura Bio, a biopharmaceutical company dedicated to developing small molecule therapies for debilitating neurological diseases, has announced the commencement of Phase 1 clinical trials for NB-4746, its SARM1 inhibitor. This marks a significant step forward in the potential treatment of various neurological conditions.

Nura Bio, Inc. has introduced NB-4746, an innovative SARM1 inhibitor that can be taken orally and penetrates the blood-brain barrier. This inhibitor holds the potential for neuroprotection and could be applicable across various central, peripheral, and ocular nervous system diseases. Promising preclinical results have shown NB-4746's ability to provide substantial structural and functional protection in models of conditions like Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Traumatic Brain Injury (TBI), and Chemotherapy-Induced Peripheral Neuropathy (CIPN). Importantly, it has displayed effectiveness in significantly reducing, and in some cases preventing, the elevation of neurofilament light (NfL) – a biomarker linked to axonal injury and disease advancement.

Dr. David Lau, Nura Bio's Senior Vice President of Development Sciences, has conveyed optimism about NB-4746's potential impact. The plan is to initiate clinical trials involving patients in 2024, focusing on evaluating how NB-4746 affects axonal injury and NfL levels.

The Phase 1 clinical trial follows a rigorous design, encompassing randomization, double-blinding, and placebo controls. This trial will involve both single ascending dose and multiple ascending dose phases and will primarily assess the safety, tolerability, and pharmacokinetics of NB-4746. Healthy volunteers will be engaged as participants in this crucial phase.

Dr. Shilpa Sambashivan, Chief Scientific Officer at Nura Bio, emphasizes that the initiation of Phase 1 trials marks the company's transition into clinical application. The progress of NB-4746 through early development stages is driven by a strong scientific foundation and a dedicated team. Nura Bio's larger objective involves advancing other compounds through pre-clinical pipelines, all with the aim of introducing groundbreaking neuroprotective treatments.

Central to Nura Bio's efforts is NB-4746, the lead asset in their small molecule pipeline. This compound is tailored to target SARM1, a neuronally enriched NAD hydrolase recognized for its role as an axon-intrinsic metabolic sensor and a significant driver of axon degeneration. Given the pivotal role axon degeneration plays in various neurological disorders, early intervention holds significant promise for delivering structural and functional neuroprotection, potentially revolutionizing the landscape of neurological disease treatment.

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