Pharma Equity Group's subsidiary, Reponex Pharmaceuticals A/S, receives regulatory approval to initiate pivotal clinical trial with RNX-011 for life-threatening peritonitis
Copenhagen, September 01, 2025
Company Announcement No. 10
Reponex Pharmaceuticals A/S (Reponex), a subsidiary of Pharma Equity Group A/S (NASDAQ: PEG), today announced that it has received regulatory approval to initiate a pivotal Phase 2 clinical trial with its drug candidate RNX-011. The study will investigate the treatment of secondary peritonitis, a serious and life-threatening intra-abdominal infection with high mortality.
The approval is a fundamental milestone for the company and a validation of the scientific strategy for RNX-011. The study addresses a critical unmet medical need in emergency abdominal surgery, where patient outcomes remain poor and where effective, local therapies to prevent serious complications are currently lacking.
About the study: Designed to demonstrate commercial value
The study is a randomized, placebo-controlled trial investigating a unique, triple-action combination therapy (fosfomycin, metronidazole, and GM-CSF) administered directly into the abdominal cavity during surgery.
The purpose of the study is to document that RNX-011 can reduce the number of serious postoperative complications, such as abscesses and the need for re-operation, which is the primary value-driving endpoint for potential partners and payers. Additionally, the study will measure the treatment's effect on local inflammation (IL-6) and patients' overall recovery (QoR-15) to support the clinical effect with strong mechanistic data.
The study is expected to enroll 32 patients, with the first patient expected to be included in Q4 2025.
"The regulatory approval of our RNX-011 study is a crucial commercial milestone for Pharma Equity Group. We are now taking the step from a strong proof-of-concept to a pivotal study designed to deliver the data that major pharmaceutical companies demand. Our goal is clear: to prove that RNX-011 can prevent life-threatening complications and fundamentally improve the treatment for a very vulnerable patient group. This approval significantly strengthens our position in the upcoming partner dialogues," says Christian Tange, CEO of Pharma Equity Group A/S.
For further information, please contact:
Christian Tange, CEO, Pharma Equity Group A/S, phone: +45 29488417
Christian Vinding Thomsen, Chairman of the Board, Pharma Equity Group A/S, phone: +45 2622 7222
About Pharma Equity Group A/S
Pharma Equity Group, a listed company on the Nasdaq Copenhagen stock exchange, is fully dedicated to advancing the medical projects of its subsidiary, Reponex Pharmaceuticals A/S. With an unwavering focus on healthcare, Pharma Equity Group's primary objective is to bring significant value to Reponex Pharmaceuticals' medical projects.
The company is committed to providing extensive support, resources, and expertise to drive the development and success of these projects. As a strategic partner, Pharma Equity Group works closely with Reponex Pharmaceuticals, prioritizing the advancement of innovative medical solutions and breakthrough therapies. Every effort is currently directed towards ensuring the utmost success and impact of Reponex Pharmaceuticals' medical projects, with an unwavering dedication to improving global healthcare outcomes. Only when the full potential of Reponex Pharmaceuticals has been unfolded is the intention to explore opportunities to invest in other companies. This approach ensures a strong commitment to the current medical projects and their development, while - in the longer term - remaining open to new strategic investments for continuous growth.
