{"id":10834,"date":"2025-05-22T16:06:32","date_gmt":"2025-05-22T20:06:32","guid":{"rendered":"https:\/\/lifescivoice.com\/?p=10834"},"modified":"2025-05-22T16:06:32","modified_gmt":"2025-05-22T20:06:32","slug":"boehringers-nerandomilast-advances-in-ipf-amid-analyst-reservations","status":"publish","type":"post","link":"https:\/\/lifescivoice.com\/boehringers-nerandomilast-advances-in-ipf-amid-analyst-reservations\/","title":{"rendered":"Boehringer\u2019s Nerandomilast Advances in IPF Amid Analyst Reservations"},"content":{"rendered":"<p>Boehringer Ingelheim\u2019s presentation of phase 3 data for its idiopathic pulmonary fibrosis (IPF) drug candidate nerandomilast has received a reserved response from analysts, who described the treatment as \u201ca step forward but not game-changing.\u201d<br \/>\nThe company had previously disclosed in September that the study met its primary endpoint, raising expectations for a potential improvement over existing antifibrotic therapies, namely Boehringer\u2019s Ofev and Roche\u2019s Esbriet.<br \/>\n<script async=\"\" src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-3812572458252831\" crossorigin=\"anonymous\"><\/script> <ins class=\"adsbygoogle\" style=\"display: block; text-align: center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-3812572458252831\" data-ad-slot=\"7669348015\"><\/ins> <script>\n     (adsbygoogle = window.adsbygoogle || []).push({});\n<\/script><br \/>\nThe study enrolled 915 patients, 78% of whom were receiving background antifibrotic treatment\u2014535 on Ofev and 380 on Esbriet. Results showed that at Week 52, patients receiving a high dose of nerandomilast had a mean lung capacity decline of \u2212114.7 ml, compared to \u2212183.5 ml in the placebo group. Among those using Ofev, the decline was \u2212118.5 ml with nerandomilast versus \u2212191.6 ml on placebo. The smallest difference was observed in the subgroup of patients taking Esbriet, where the low dose of nerandomilast performed worse than placebo.<br \/>\nIn a note dated May 19, Leerink Partners analysts commented that nerandomilast \u201clooks to us to be an incrementally better Ofev,\u201d but emphasized it remains a disease-slowing rather than disease-halting agent. They characterized it as \u201ca decent Ofev-successor\u201d but noted that its \u201cmodest effect size\u201d was unlikely to prompt immediate changes in IPF treatment practices.<br \/>\nConcerns were also raised about the drug\u2019s interactions with current therapies. According to Boehringer, drug-drug interactions between nerandomilast and Esbriet were responsible for the low dose\u2019s failure to improve outcomes in that subgroup. In addition, overlapping toxicity was observed with Ofev. Diarrhea was the most frequently reported adverse event, affecting 41% of patients on the high dose of nerandomilast and occurring most often among those concurrently using Ofev.<br \/>\n<script async=\"\" src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-3812572458252831\" crossorigin=\"anonymous\"><\/script> <ins class=\"adsbygoogle\" style=\"display: block; text-align: center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-3812572458252831\" data-ad-slot=\"7669348015\"><\/ins> <script>\n     (adsbygoogle = window.adsbygoogle || []).push({});\n<\/script><br \/>\nLeerink analysts pointed out that this overlap in tolerability could limit the feasibility of using nerandomilast alongside Ofev. \u201cDiarrhea leading to discontinuation was mainly observed with background [Ofev] use, which we think may limit the number of patients who are able to tolerate concurrent use,\u201d they wrote.<br \/>\nWhile the analysts acknowledged that nerandomilast demonstrated a \u201csolid profile that warrants approval,\u201d they also highlighted the opportunity this leaves for other developers in the IPF space. The perceived limitations of nerandomilast were cited as a positive development for PureTech Health and MannKind, both of which are currently advancing their own IPF programs.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Boehringer Ingelheim\u2019s presentation of phase 3 data for its idiopathic pulmonary fibrosis (IPF) drug candidate nerandomilast has received a reserved response from analysts, who described the treatment as \u201ca step forward but not game-changing.\u201d The company had previously disclosed in September that the study met its primary endpoint, raising expectations for a potential improvement over [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":10835,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[35],"tags":[],"class_list":{"0":"post-10834","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-clinical"},"_links":{"self":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts\/10834","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/comments?post=10834"}],"version-history":[{"count":1,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts\/10834\/revisions"}],"predecessor-version":[{"id":10836,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts\/10834\/revisions\/10836"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/media\/10835"}],"wp:attachment":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/media?parent=10834"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/categories?post=10834"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/tags?post=10834"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}