Pharma Equity Group (“PEG” or “the Company”) announced on Friday, December the 13th, the board of directors’ decision on a new execution strategy and prioritization of clinical areas regarding the Company’s subsidiary Reponex Pharmaceuticals A/S (“Reponex”).
PEG conducts continuous evaluation of the clinical pipeline in regards to Reponex based on several 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 prioritized the following development programs going forward:
- RNX-051 for Colon Adenomas and Colon Cancer
- RNX-011 for the Treatment of Peritonitis
- RNX-041 for the Treatment of IBD (Pouchitis)
The abovementioned drug candidates have demonstrated relevant, informative, and clinical data, with patent protection secured in the most critical geographical regions for the Company.
Development of RNX-051 and RNX-011
In recent months, PEG and the Company’s clinical partners have allocated significant resources to finalize study protocols in preparation for the submission of Phase 2 clinical trial applications to regulatory authorities. The trial applications for RNX-011 and RNX-051 are expected to be submitted at the beginning and end of Q1-25, respectively. During Q1-25, Reponex will implement laboratory models using blood samples from patients with peritonitis to confirm the disease mechanisms affected by RNX-011. These results will help to determine the correct dosage of the drug and generate an ongoing data package. This initiative will not only support clinical studies but also enable the individualization of treatment for patients with peritonitis.
Development of RNX-041
Regarding RNX-041, the drug candidate 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 trials (IITs), designed in compliance with FDA and EMA guidelines, as well as anticipated requirements from future industrial licensing partners. Furthermore, the study design enables continuous analysis and timely data release.
Recent activities
The Company is also working to establish strategic partnerships, a process that will continue throughout the completion of the abovementioned studies. Additionally, Reponex has unblinded the proof-of-concept study with RNX-021 for the treatment of chronic venous leg ulcers. As anticipated, data from the study have provided significant and valuable insights for further formulation work, with a focus on optimizing drug candidates regarding future clinical studies involving RNX-022 and RNX-023. Moreover, the Company’s drug candidates for the treatment of chronic leg ulcers (RNX-022, RNX-023) and Crohn’s Disease (RNX-041) remain of great clinical and commercial interest. These programs will continue to advance through strategic clinical and industrial collaborations.
Analyst Group’s view of the new execution strategy and prioritization of clinical areas
“Analyst Group views the new execution strategy and prioritization of clinical areas as a positive step, enabling the Company to allocate resources to drug candidates with the shortest routes to market. Prioritizing these programs, supported by robust clinical data and patent protection, enhances the regulatory and commercial potential, which may accelerate the path to licensing agreements and cash flows.
The colorectal cancer market, which PEG addresses through RNX-051, was valued at USD 19bn in 2022 and is estimated to witness a 4.0% CAGR from 2022 to 2030, reaching USD 26bn by 2030.1 In the year 2020, approximately 12.7% of new cancer diagnoses and 12.4% of cancer-related deaths were attributed to colorectal cancer in EU-27 countries – this positioning marks it as the second most prevalent cancer, following breast cancer, and the second leading cause of cancer-related mortality, after lung cancer.2 Hence, the need of new innovative treatment methods in regards to colorectal cancer can be included in effective cancer treatment is more urgent than ever.
Looking at the market that RNX-011 targets, secondary peritonitis poses an increasing challenge and burden for individuals as well as the healthcare system, constituting 1% of urgent hospital admissions and ranking as the second most common cause of sepsis (blood poisoning).3 The global peritonitis treatment market is expected to grow at a CAGR of 6.1% from 2020 to 2028, driven by a rising prevalence and increased investments in R&D to develop permanent and adequate treatment options, originating from both public and government sectors.4
Additionally, the need adequate treatment methods for pouchitis speaks in favor of RNX-041, where a heightened preference for effective yet less invasive symptomatic therapeutics and biologics are fueling the market growth. The global inflammatory bowel disease (IBD) market had, according to ReportLinker, an estimated value of USD 21.3b in 2023 and is expected to experience a 4.8% CAGR during 2023-2027, thereby reaching USD 25.7bn by 2027.5
In summary, Analyst Group believes that focusing on drug candidates with the most favorable near-term outlook and efficiently allocating time and capital is the right approach. With a strengthened balance sheet following the recent directed share issue of.. , a more streamlined focus, and several potential triggers anticipated in early 2025, PEG is well positioned to make significant progress toward licensing agreements in the coming year.”
1. https://www.databridgemarketresearch.com/reports/global-colorectal-cancer-treatment-market
2. https://ecis.jrc.ec.europa.eu/sites/default/files/2023-12/Colorectal_cancer_en-Mar_2021.pdf
3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6889898/?report=printable
4. https://www.databridgemarketresearch.com/reports/global-peritonitis-treatment-market
5. https://www.reportlinker.com/p06317616/Inflammatory-Bowel-Disease-Treatment-Global-Market-Report.html?utm_source=GNW
