Neuraltus Pharmaceuticals, Inc., is currently enrolling up to 120 individuals with ALS and evidence of systemic inflammation in a second Phase 2 study of its investigational treatment NP001, an immune system regulator. Inflammation is thought to be a contributing factor to ALS disease progression and existing NP001 data suggest that it may have an effect on inflammation in the immune system. This additional Phase 2 study is being conducted to test whether NP001 slows the progression of ALS symptoms in patients who have evidence of increased inflammatory activity in their blood.
The study is a randomized, double-blind, placebo-controlled, multicenter study in North America. Patients will receive NP001 or placebo intravenously for 5 days in a row during the first month and for 3 days in a row in Months 2 through 6. There will be an end-of-study visit at Month 7. The study will explore the effects of NP001 versus placebo by looking at a functional rating scale questionnaire, pulmonary function, time to tracheotomy and inflammatory biomarkers. See press release for more information: http://www.neuraltus.com/february-8-2017
For questions, please contact Frances Faurot at Neuraltus Pharmaceuticals