Pharma Equity Group's subsidiary, Reponex Pharmaceuticals A/S, receives regulatory approval to initiate pivotal clinical trial with RNX-011 for life-threatening peritonitis

Core Viewpoint - Reponex Pharmaceuticals A/S has received regulatory approval to initiate a pivotal Phase 2 clinical trial for RNX-011, targeting secondary peritonitis, a life-threatening condition with high mortality rates [1][2]. Group 1: Study Details - The clinical trial is a randomized, placebo-controlled study that will evaluate a triple-action combination therapy (fosfomycin, metronidazole, and GM-CSF) administered directly into the abdominal cavity during surgery [3]. - The primary endpoint of the study is to demonstrate that RNX-011 can reduce serious postoperative complications, such as abscesses and the need for re-operation [4]. - The study will also assess the treatment's impact on local inflammation (IL-6) and overall patient recovery (QoR-15) to provide strong mechanistic data [4]. Group 2: Company Perspective - The approval is seen as a crucial commercial milestone for Pharma Equity Group, transitioning from proof-of-concept to a pivotal study that aims to deliver data required by major pharmaceutical companies [6]. - The company emphasizes its commitment to advancing Reponex Pharmaceuticals' medical projects and improving healthcare outcomes globally [8]. - Pharma Equity Group intends to focus on the success of Reponex Pharmaceuticals before exploring new strategic investments [8]. Group 3: Study Enrollment - The study is expected to enroll 32 patients, with the first patient anticipated to be included in Q4 2025 [5].