Nura Bio, a leading biopharmaceutical company specializing in neuroprotective, small molecule therapies, announced today the initiation of Phase 1 clinical trials for its groundbreaking SARM1 inhibitor, NB-4746. This first-in-class, oral, brain-penetrating inhibitor offers broad therapeutic potential across a range of neurological conditions, including Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Traumatic Brain Injury (TBI), and Chemotherapy-Induced Peripheral Neuropathy (CIPN).

NB-4746 Proves Promising in Preclinical Disease Models

Innovative Therapy Significantly Reduces Neurofilament Light (NfL) Levels

NB-4746 has demonstrated significant structural and functional protection in preclinical models for several debilitating neurological diseases. Furthermore, the inhibitor has significantly reduced—and in some instances even prevented—an increase in the levels of the disease-associated biomarker neurofilament light (NfL). “We are excited about the potential of NB-4746 and expect to evaluate its impact on axonal injury and NfL levels in clinical trials slated for 2024,” said David Lau, PhD, Senior Vice President of Development Sciences at Nura Bio.

Details of the Phase 1 Clinical Trial: Safety, Tolerability, and More

Randomized, Double-Blind, Placebo-Controlled Study to Assess NB-4746

The Phase 1 clinical trial is set to be a randomized, double-blind, placebo-controlled study. This trial aims to assess the safety, tolerability, and pharmacokinetics of NB-4746 in healthy volunteers. It is designed as both a single ascending dose and multiple ascending dose study, further underlining Nura Bio’s meticulous approach to drug development.

Nura Bio Transitions to Clinical-Stage Company

Strong Scientific Foundation Fuels Rapid Progression of NB-4746

“The initiation of the Phase 1 trial marks Nura Bio’s transition to a clinical-stage company,” stated Shilpa Sambashivan, Chief Scientific Officer at Nura Bio. The company, backed by a robust scientific foundation and a dedicated team, is progressing NB-4746 rapidly through its early development stages. Nura Bio also continues to advance additional molecules in its pre-clinical pipeline, aiming to deliver potentially life-changing neuroprotective medicines to the market.

By advancing into Phase 1 clinical trials, Nura Bio is carving out its space as a front-runner in the quest to develop revolutionary neuroprotective therapies, underscoring its commitment to combating some of the world’s most debilitating neurological diseases.

  amyotrophic lateral sclerosis, David Lau, Multiple sclerosis, NB-4746, peripheral neuropathy, SARM1 inhibitor, Shilpa Sambashivan, traumatic brain injury, USA