The Board of Directors’ decision on a new execution strategy and prioritisation of clinical areas in Reponex Pharmaceuticals A/S.

The Board of Directors’ decision on a new execution strategy and prioritisation of clinical areas in Reponex Pharmaceuticals A/S.

December 13, 2024
Announcement No. 32

Pharma Equity Group conducts continuous evaluation of the clinical pipeline of Reponex Pharmaceuticals A/S (Reponex) based on a number of fundamental commercial criteria, including medical need, patient recruitment, regulatory requirements, likelihood of success and requirements for both human and monetary capital.
Based on this evaluation, Reponex has chosen to give top priority to the following development programmes: 

• RNX-051 for Colon Adenomas and Colon Cancer
• RNX-011 for the Treatment of Peritonitis
• RNX-041 for the treatment of IBD (pouchitis)

The mentioned development programs have all shown relevant, informative and strong clinical data, and have obtained patent protection in the most important geographical areas for the company.

 
In recent months, the Company and its clinical partners have therefore allocated significant resources to the final preparations and finalization of the study protocols for the submission of the Phase 2 clinical trial applications to the authorities. The trial applications for RNX-011 and RNX-051 are expected to be submitted to the authorities at the beginning of Q1-2025 and the end of Q1-2025, respectively.

In Q1-2025, Reponex will implement laboratory models based on blood samples from patients with peritonitis and used to confirm the disease mechanisms that RNX-011 affects. Through these results, the correct dosage of the drug will be tested on the patient’s blood sample and thereby generate an ongoing data package. The initiative will not only support clinical studies, but enable individualisation of the treatment of patients with peritonitis.

RNX-041 is actively included in Part 2 of the ongoing Phase 2 proof-of-concept clinical study for the treatment of pouchitis.

The studies are conducted as investigator-initiated studies (IITs), designed in compliance with guidelines from the FDA and EMA as well as expected requirements from future industrial license partners. In addition, it is emphasized that the study design enables continuous analysis and release of data.
  
The company works continuously to establish strategic partnerships – a process that will continue during the completion of the studies.

The company has unblinded the proof-of-concept study with RNX-021 for the treatment of chronic venous leg ulcers. As expected, data from the proof-of-concept study provide the company with significant and valuable information for use in the continued formulation work with a focus on optimizing the drug candidates for future clinical studies with RNX-022 and RNX-023.

The Company’s drug candidates in the treatment of chronic leg ulcers (RNX-022, RNX-023) and Crohn’s Disease (RNX-041) continue to be considered of great interest both clinically and commercially. These programmes will be pursued through strategic clinical and industrial cooperation.

For further information, please contact:

Christian Vinding Thomsen, Chairman of the Board of Directors of Pharma Equity Group A/S, phone: +45 2622 7222