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Correction: Pharma Equity Group's subsidiary, Reponex Pharmaceuticals A/S, receives regulatory approval to initiate pivotal clinical trial with RNX-011 for life-threatening peritonitis
PSEGPSEG(US:PEG) Globenewswireยท2025-09-02 08:04

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 serious intra-abdominal infection with high mortality rates [2][3]. Group 1: Regulatory Approval and Study Design - The approval marks a significant milestone for the company and validates the scientific strategy behind RNX-011 [3]. - The study is a randomized, placebo-controlled trial that will investigate a triple-action combination therapy (fosfomycin, metronidazole, and GM-CSF) administered directly into the abdominal cavity during surgery [4]. - The trial aims to enroll 32 patients, with the first patient expected to be included in Q4 2025 [6]. Group 2: Study Objectives and Expected Outcomes - The primary objective of the study is to demonstrate that RNX-011 can reduce serious postoperative complications, such as abscesses and the need for re-operation, which are critical for potential partners and payers [5]. - The study will also assess the treatment's effect on local inflammation (IL-6) and overall patient recovery (QoR-15) to provide strong mechanistic data supporting clinical efficacy [5]. Group 3: Company Strategy and Future Outlook - The regulatory approval is viewed as a crucial commercial milestone, transitioning from proof-of-concept to a pivotal study that aims to deliver data required by major pharmaceutical companies [7]. - Pharma Equity Group is committed to supporting Reponex Pharmaceuticals in advancing its medical projects, focusing on innovative solutions and breakthrough therapies [9][10].