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The company’s lead asset demonstrated neuroprotection in preclinical models of nerve injury and disease. Credit: Jo Panuwat D/Shutterstock. Nura Bio has secured an additional $68m in a Series A financing round to advance the development of its neuroprotective therapies. The latest funding brings the total funds raised by the company to more than $140m with $73m in an initial Series A round in 2020. The Column Group led the investment round, with continued support from Samsara Bio Capital and Euclidean Capital, and new backing from Sanofi Ventures. Nura Bio’s recent funding milestone coincides with the successful completion of Phase I studies for its lead clinical candidate, NB-4746, in healthy subjects. A brain-penetrant SARM1 inhibitor, NB-4746 has demonstrated potential in preventing axon degeneration and offering neuroprotection in preclinical models of nerve injury and disease. See Also: AstraZeneca’s Fasenra to challenge GSK’s Nucala in rare vasculitis after FDA nod FDA approves Accord BioPharma’s HERCESSI for cancer treatment The Phase I trial data indicated that NB-4746 was well-tolerated in both single ascending and multiple ascending dose arms, achieving targeted plasma exposure levels believed to be necessary for efficacy without serious treatment-emergent adverse events. Cerebrospinal fluid levels of NB-4746 confirmed brain penetration, bolstering the molecule’s prospects for treating conditions impacting the peripheral and central nervous systems. The company is preparing to commence a Phase Ib/II trial with NB-4746 in patients by 2025. In conjunction with the latest funding, the company appointed Shilpa Sambashivan as its new CEO and board member. Dr Sambashivan stated: “At Nura Bio, we have been laser-focused on our mission of delivering novel neuroprotective therapies to patients by leveraging our deep scientific understanding of underlying disease mechanisms including axon degeneration and neuroinflammation. The strong support demonstrated by our investors through this financing reflects the tremendous potential of our research and development pipeline. “I am proud of the results our team has delivered. I look forward to leading the company through this next phase as we prepare to test the SARM1 hypothesis in a patient population in 2025 with our lead candidate NB-4746 while continuing to advance our promising preclinical pipeline.”

Neurodegenerative disorders progress in a variety of ways, but one characteristic many of them share is the breakdown of axons, a cable-like fiber that extends from a neuron and transmits electrical signals. While scientists have long known about axon degeneration, they haven’t had tools to stop it. Nura Bio’s lead drug candidate blocks a novel target associated with this damage to axons and the startup now has $68 million to proceed to a Phase 2 test. The new financing announced Tuesday was led by founding investor The Column Group. Along with the new capital, South San Francisco-based Nura Bio announced the appointment of Shilpa Sambashivan as CEO and a member of the company’s board of directors. The initial target of Nura Bio’s research is SARM1, an enzyme that is involved in axonal degeneration. SARM1 is not activated in healthy people and if it has a role in states of health, scientists have not found it, Sambashivan said. But once activated, the enzyme leads to axonal degeneration. That activation can be sparked by a chemical injury, such as chemotherapy, or a physical one, such as traumatic brain injury. presented by Health IT Accelerating Claim Processing: Strategies to Shorten the Life of a Claim These strategies and practices can significantly shorten the life cycle of claims, leading to quicker resolutions and improved financial outcomes. By Greenway Health “We all know that axon degeneration is important,” said Sambashivan, who was part of Nura Bio’s founding team and previously served as the startup’s chief scientific officer. “We thought of it as a passive process. This is not a passive process. There is actually a mechanism in axons that is sensitive to changes in the environment.” Nura Bio aims to stop axon degeneration with a brain-penetrating drug that inhibits SARM1. The company’s lead program, NB-4746, recently completed Phase 1 testing in healthy volunteers. Sambashivan said results showed the twice-daily pill was well tolerated with no adverse effects. Scientists confirmed that the drug penetrated into the brain by measuring for it in cerebrospinal fluid. However, Sambashivan said the Phase 1 test was unable to show whether NB-4746 engaged SARM1 in the healthy volunteers because the enzyme is activated only in states of disease. Showing the drug’s effect on the target enzyme will come with the next stage of clinical testing. The Phase 1b/2 test is expected to begin in 2025 in a yet-to-be-determined neurological indication. Sambashivan said one key measure of this study will be to measure levels of neurofilament light (NfL) proteins, a type of protein released into the blood by damaged neurons. These proteins are a biological indicator for neurological disease and they are an indirect way to measure SARM1, Sambashivan said. There’s precedent for using NfL levels as a surrogate clinical trial endpoint. The reduction of blood levels of this protein was the basis for the 2023 accelerated FDA approval of Biogen’s Qalsody, a treatment for amyotrophic lateral sclerosis (ALS) driven by a certain genetic mutation. Sambashivan acknowledged ALS is one potential indication for Nura Bio’s NB-4746. Others include multiple sclerosis and chemotherapy-induced peripheral neuropathy. In 2022, the company published research in the journal Neuron showing SARM1 inhibitors were neuroprotective in preclinical models of nerve injury and neuropathy. Reduction of NfL levels was a key measure of this research. While Nura Bio believes its lead program has potential applications in a wide range of neurological disorders, Sambashivan said the company is still determining which indication to choose first to demonstrate proof of biology. presented by Health Tech The Promise of Value-Based Care and MedTech Innovation Monica Vajani, Executive Director for mHUB’s MedTech Accelerator, discusses how mHUB is helping innovators transition healthcare towards value-based care. By Monica Vajani Nura Bio’s approach is based on the SARM1 research of scientific founders Marc Freeman of Oregon Health & Science University and Steven McKnight of University of Texas Southwestern Medical Center. The startup’s drugs (additional pipeline details and drug targets remain undisclosed) were all discovered within the company, Sambashivan said. Nura Bio’s SARM1 efforts face potential competition from Eli Lilly. In 2020, the pharmaceutical giant acquired Disarm Therapeutics, a startup that was in preclinical development with SARM1 inhibitors. The M&A deal came three years after the startup emerged from stealth with science based on the SARM1 research of its Washington University academic co-founders. Lilly’s pipeline currently lists a SARM1 inhibitor in Phase 1 development as a potential treatment for neurodegeneration. Asked what differentiates Nura Bio’s approach from Disarm’s, Sambashivan said all Nura Bio knows about the Disarm research is what is in the public domain, which is not much. She added that her company does not have additional insight to offer at this time. Nura Bio’s new financing adds to a $73 million Series A financing announced in 2020, extending the round’s total to $141 million. Sanofi Ventures joined the latest round as a new investor. Other participants include earlier investors Samsara Bio Capital and Euclidean Capital. Sambashivan said the new capital is enough to get Nura Bio’s lead program to the end of the proof-of-biology clinical trial. Even though Nura Bio just closed the additional financing, the startup is already preparing for the next round. “Once you get to the clinical stage and you’re moving more molecules into the clinic, you’re always raising,” Sambashivan said. Photo by Nura Bio