Stopping
ALS progression
Transforming inflammatory macrophages
to stop the progression of
motor neuron damage

About
A new treatment for ALS that addresses patients who are non-responsive to current therapy options

Neuvivo is dedicated to creating therapeutics for the treatment of Amyotrophic Lateral Sclerosis (ALS) and other neurodegenerative diseases. We have developed a patented macrophage-targeted technology, NP001, that addresses chronic inflammation, a key factor in the progressive loss of motor function in ALS.

To date, the treatment has received Orphan Drug and Fast Track designation by the FDA as it addresses a clear unmet medical need. We are focused on quickly moving this compound toward approval and are committed to delivering an effective new treatment to reduce the suffering caused by this devastating disease.

Science
Regulating inflammatory macrophages back to their non-inflammatory wound-healing state

ALS is a neurological disorder that causes the loss of motor neurons and results in progressively debilitating muscle weakness. There is an emerging consensus that ALS disease progression is associated with systemic inflammation and abnormal inflammatory macrophage/microglia activity within affected spinal cord and brain regions. Macrophages are white blood cells, critical for wound healing, clearance of bacteria, and resolution of inflammation. In one state (M1), macrophages are toxic, producing inflammatory cytokines (TNF-α) and other proinflammatory factors. In a second state (M2), macrophages are neuroprotective and associated with the reversal of inflammation and the suppression of uncontrolled immune responses. In ALS, the appearance of new M1 macrophages in the spinal cord indicates disease progression.
Microglia are a type of macrophage located throughout the brain and spinal cord, accounting for 10-15% of all cells found within the brain.
They are a subset of macrophage cells and act as the first and main form of active immune defense in the central nervous system (CNS). Microglial inflammatory activation has been observed consistently in association with degenerating upper and lower motor neurons.
Neuvivo’s therapeutic, NP001, is a small molecule which, through a series of biochemical interactions in the body, is converted to a compound that transforms inflammatory macrophages (M1) to the non-inflammatory, wound healing state (M2), to stop damage to motor neurons.

Current research points to compromised macrophage function as a critical factor in many other CNS diseases, such as Parkinson’s Disease and Alzheimer’s Disease, suggesting that NP001 could successfully treat a range of CNS diseases.

Patients
NP001 has been shown to have an exceptional safety* profile in people living with ALS

ALS is a neurological disorder that causes the loss of motor neurons with grave consequences for the patient. There are approximately 40,000-50,000 people living with ALS in the US and Europe. There are just two currently approved therapies to treat the disease but neither has a significant effect on improving quality of life, nor has been shown to extend lifespan more than a few months. Additionally they are only indicated for a small subset of people living with ALS.

Neuvivo has developed NP001, a proprietary small molecule therapeutic that has been shown in clinical trials to halt the progression of the disease and is primed to submit to the FDA. In three clinical trials*, NP001 has demonstrated an excellent safety profile; no drug-related serious adverse events have occurred. NP001 is on course to arrest the progression of this disease for which there are currently few effective options.

Neuvivo is working closely with leading ALS clinicians and researchers to deliver an effective treatment for people living with ALS – as soon as possible.

* Miller RG, Zhang R, Block G, et al. NP001 regulation of macrophage activation markers in ALS: a Phase I clinical and biomarker study. Amyotroph Lateral Scler Frontotemporal Degener 2014;15:601–609.

Miller RG, Block G, Katz JS, Barohn RJ, Gopalakrishnan V, Cudkowicz M, et al. Randomized Phase 2 trial of NP001-a novel immune regulator: Safety and early efficacy in ALS. Neurol Neuroimmunol Neuroinflamm. 2015;2(3):e100.

Pipeline
NP001 has gained Orphan Drug and Fast Track Status from the FDA

Neuvivo has completed two Phase 2 trials, providing significant data that demonstrates the efficacy of NP001 in halting the progression of ALS and protecting motor neurons. The treatment has shown a robust safety profile with no drug-related serious adverse events.
NP001 has strong IP protection. 8 patents have been issued in the US and ROW with protection extending through 2042. Additional patents have been filed.
With the completion of the pre-clinical research and the demonstration of safety, Neuvivo is in a position to initiate Phase 2 studies in Parkinson’s Disease, Alzheimer’s Disease and Vascular Dementia.

Founders

Executive Team

Career
Join our team

The team at Neuvivo is committed to developing groundbreaking, effective treatments for ALS and other motor neuron diseases.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.

If you share our passion, we encourage you to contact us at careers@neuvivo.com