Biopharmaceutical company Neuraltus Pharmaceuticals has announced plans to initiate a second Phase II ALS clinical trial testing NP001, a regulator of inflammatory macrophages and their monocyte precursors. The first Phase IIa clinical trial, which examined safety, tolerability, and preliminary efficacy of NP001 in 136 patients, was completed in 2012. In that study, NP001 caused a clinically meaningful decrease in the rate of disease progression in a subset of patients treated with high dose NP001 who also had elevated baseline inflammation (Miller, RG et al., 2015). Secondary analysis of the Phase IIa data suggested that the inflammatory marker C-reactive peptide (CRP) may be a biomarker of the patient subgroup most likely to benefit from high-doses of NP001. The company is now developing a new Phase II study protocol to validate the initial findings and test CRP as a biomarker to enrich patient selection for future NP001 trials.
Neuraltus aims to begin enrollment for the study in the summer of 2016.
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