On receipt of approval, this asset could become the first disease-modifying therapy for ALS, focusing on immunologic mechanisms rather than neurologic.
A sodium chlorite infusion, NP001 has been designed to restore the balance of the body’s innate immune system, which can become dysregulated in ALS.
By targeting the pro- and anti-inflammatory processes, NP001 may slow the progression of the disease and help preserve vital skeletal muscle function.
The treatment previously already received orphan drug and fast track designations from the FDA, making it eligible for accelerated approval and priority review.
Clinical studies have shown that NP001 is generally safe and well-tolerated.
Currently, there are no medications available that significantly extend life or preserve breathing function in ALS patients beyond two to three months.
Neuvivo founder and CEO Ari Azhir said: “ALS is a devastating disease and patients who are fighting ALS need much better treatment options.
“Our organisation was built on our passion and commitment to help those struggling with ALS by finding new treatments that can make a meaningful difference in their quality of life. We are thrilled to have submitted NP001 for FDA approval as the treatment platform may substantially preserve lung function and extend overall survival by up to a year, especially in patients identified through therapeutic biomarkers as having underlying, uncontrolled inflammation as a result of ALS.”
In June last year, Neuvivo secured $11m in a financing round led by PrimeStreet Capital.
This funding has been instrumental in advancing the development and regulatory submission of NP001.