{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,2]],"date-time":"2026-07-02T07:47:53Z","timestamp":1782978473671,"version":"3.54.5"},"reference-count":26,"publisher":"MDPI AG","issue":"9","license":[{"start":{"date-parts":[[2025,5,3]],"date-time":"2025-05-03T00:00:00Z","timestamp":1746230400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Neuvivo, Inc. (Palo Alto, CA, USA)","award":["Neuvivo-NP001"],"award-info":[{"award-number":["Neuvivo-NP001"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["IJMS"],"abstract":"<jats:p>Amyotrophic lateral sclerosis (ALS) is a heterogeneous disease that involves progressive loss of voluntary muscle and ultimately, respiratory function, which is the primary cause of death in ALS patients. Respiratory vital capacity (VC) measurements are objective, reproducible, and directly related to survival. Respiratory function is known to be negatively affected in individuals with excess abdominal fat contributing to a chronic innate immune inflammatory state. To test whether ALS patients might have a body mass index (BMI) related VC response to the innate immune system regulator NP001, clinical results from two NP001 phase 2 trials were evaluated in an intent-to-treat manner, stratified by BMI measurements. Slowing of progressive VC loss and extension of overall survival (OS) occurred primarily in ALS patients who were overweight with a BMI \u2265 25 (70% of patients in the phase 2 trials). Innate immune dysfunction is a characteristic of ALS patients \u2264 65 years of age, and in this group both VC and OS changes in response to NP001 were most significant. This study represents a novel approach to ALS, wherein VC and OS were both significantly improved through immunologic, not neurologic modulation with NP001, a precursor to the dominant regulator of inflammation, taurine chloramine.<\/jats:p>","DOI":"10.3390\/ijms26094349","type":"journal-article","created":{"date-parts":[[2025,5,4]],"date-time":"2025-05-04T20:10:27Z","timestamp":1746389427000},"page":"4349","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Respiratory Function Improvement and Lifespan Extension Following Immunotherapy with NP001 Support the Concept That Amyotrophic Lateral Sclerosis (ALS) Is an Immuno-Neurologic Disease"],"prefix":"10.3390","volume":"26","author":[{"given":"Rongzhen","family":"Zhang","sequence":"first","affiliation":[{"name":"Department of Medicine, University of California San Francisco, San Francisco, CA 94110, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ari","family":"Azhir","sequence":"additional","affiliation":[{"name":"Neuvivo, Inc., Palo Alto, CA 94303, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7232-2602","authenticated-orcid":false,"given":"Michael S.","family":"McGrath","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of California San Francisco, San Francisco, CA 94110, USA"},{"name":"Neuvivo, Inc., Palo Alto, CA 94303, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,5,3]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"156","DOI":"10.1002\/mus.26801","article-title":"Addressing heterogeneity in amyotrophic lateral sclerosis CLINICAL TRIALS","volume":"62","author":"Goyal","year":"2020","journal-title":"Muscle Nerve"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"e100","DOI":"10.1212\/NXI.0000000000000100","article-title":"Randomized phase 2 trial of NP001-a novel immune regulator: Safety and early efficacy in ALS","volume":"2","author":"Miller","year":"2015","journal-title":"Neurol. 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