June 02, 2022

Neuvivo’s NP001 – an Immune System Regulator – Has Effect on Biomarkers of Microbial Translocation in ALS Patients Responsive to Treatment

Palo Alto, CA and Edinburgh, Scotland, June 2, 2022 – Today, at the ENCALS Conference (European Network to Cure ALS) Neuvivo presented an abstract titled: “Plasma biomarkers of microbial translocation are modulated in ALS patients clinically responsive to NP001”.

Microbial translocation (MT) occurs when bacteria or bacterial products that should only be in the lumen of the intestine, travel across the epithelial barrier into systemic circulation, where they contribute to chronic inflammation and disease pathogenesis. This is a process known to occur in patients with ALS and other neurodegenerative diseases. NP001 is a regulator of innate immunologic function converting inappropriately activated macrophages that promote MT to a normal wound healing form that can reverse the MT process.

In phase 2 studies with NP001 in ALS patients, clinical signs of disease activity and respiratory vital capacity were positively affected compared to controls. Plasma specimens obtained during the phase 2A study were evaluated for levels of inflammatory markers related to MT at baseline and after 6 months and compared to placebos.  Baseline markers of MT (LPS, LBP, sCD163, IL-18) all decreased significantly in the NP001 treatment arm as compared to placebos (p = 0.04, 0.006, 0.02, 0.02, respectively) whereas the plasma levels of wound healing epidermal growth factor (EGF) and neopterin increased in patients treated with NP001 (p = 0.04 and 0.02 respectively).

“NP001 treatment reduced inflammation and importantly, enhanced production of wound healing factors,” said Michael McGrath, MD, PhD, Chief Scientific Officer, Neuvivo.  “The clear clinical improvement in patients as measured by ALSFRS-R and Vital Capacity scores, coupled with NP001‘s known mechanism of action targeting the immune system - suggests that reversal of MT may alter ALS pathogenesis. Taken together, the NP001 trial data links positive clinical outcomes with changes in biomarker levels supporting NP001 as a potentially effective therapy for ALS through regulation of MT.”

About Neuvivo: Neuvivo is a private, late-clinical stage biopharmaceutical company committed to creating and delivering advanced treatments for ALS and other neurodegenerative diseases.  The company was formed by industry leaders and scientists, committed to improving the prognosis for patients diagnosed with ALS and a range of diseases for which few current treatment options exist.  For more information please visit: www.Neuvivo.com.

Editor’s Note:  Lou Gehrig Day - The baseball great passed on this day, June 2 in 1941 having taken himself out of the starting lineup in May 1939 when his performance on the field became hampered by an undiagnosed ailment, later confirmed to be amyotrophic lateral sclerosis (ALS) an incurable neuromuscular illness.  80 years have passed since but there are only two broadly-available treatments for this devastating disease that today is still 100% fatal.