Neuraltus Pharmaceuticals Inc. recently announced that it has begun a second Phase 2 trial of NP001, its investigational treatment designed for patients who have amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease.
"NP001 is a very promising investigational therapy for ALS and other related neurodegenerative diseases," Nueraltus Scientific Advisory Board Director Dr. Lawrence Steinman said. "The drug's anti-inflammatory mechanism of action is very attractive and capitalizes on numerous recent research insights about the importance of the immune system in driving the progression rates of many neurodegenerative disorders. The preliminary evidence from the company's first Phase 2 clinical trial of NP001 is quite compelling and should be confirmed by this next Phase 2 trial in patients with elevated levels of CRP."
Increased levels of a biomarker for systemic inflammation, C-reactive protein (CRP), may indicate which patients are more likely to have a positive response, a secondary analysis of the study results suggested.
The primary endpoint of the trial will be to study the effects of NP001 and determine if patients will benefit from the treatment.
"The initiation of the second Phase 2 study of NP001 marks an important step in ALS research," Neuraltus Pharmaceuticals CEO Rich Casey said. "We are encouraged by the results of the first Phase 2 study of NP001 and pleased to continue our evaluation of this innovative, targeted investigational therapy for people suffering from this progressive and life-threatening condition."