Investment
Investment Strategy
Pharma Equity Group, as an investment
company listed on the stock exchange, currently places its primary investment
focus on promoting its subsidiary, Reponex Pharmaceuticals A/S. With a
dedicated approach, Pharma Equity Group aims to maximize the growth and success
of Reponex Pharmaceuticals through strategic investments.
Recognizing Reponex Pharmaceuticals
as a valuable asset within its portfolio, Pharma Equity Group directs its
resources towards supporting the advancement of Reponex Pharmaceuticals’
clinical candidates and therapies. The company’s investment strategy is
tailored to leverage the potential of Reponex Pharmaceuticals’ innovative
pipeline, which addresses unmet medical needs and aims to improve patient
outcomes.
In evaluating investment
opportunities, Pharma Equity Group diligently assesses Reponex Pharmaceuticals’
management team strength, product viability, growth potential, and competitive
landscape. The focus is on aligning the investments with Reponex
Pharmaceuticals’ long-term goals and ensuring a well-balanced portfolio that
optimizes risk diversification.
While Pharma Equity Group maintains an overarching investment strategy in the life science industry, its current primary investment focus is directed towards promoting the growth, development, and success of Reponex Pharmaceuticals A/S. By leveraging its expertise, resources, and industry network, Pharma Equity Group is dedicated to fostering the advancement of Reponex Pharmaceuticals’ groundbreaking therapies and maximizing their potential for long-term returns.
Looking ahead, Pharma Equity Group recognizes the importance of exploring new
investment opportunities in the pharmaceutical industry. While the primary
investment focus currently lies on promoting Reponex Pharmaceuticals A/S, the
company remains proactive in keeping abreast of developments in the
pharmaceutical market. Pharma Equity Group acknowledges the significance of identifying
promising pharmaceutical companies in their early stages, particularly those
prior to phase 2. By continuously monitoring the industry landscape, staying
informed about emerging trends, and engaging with industry experts, Pharma
Equity Group positions itself to seize potential investment prospects that
align with its investment objectives. This forward-thinking approach ensures
that Pharma Equity Group remains agile, adaptable, and well-prepared to
capitalize on future opportunities for sustainable growth and success in the
pharmaceutical sector.
Reponex Pharmaceuticals A/S
Pharma Equity Group’s transaction with Reponex was approved in February 2023. Reponex Pharmaceuticals A/S is a clinical-stage biopharmaceutical company dedicated to the development of new, effective treatments for diseases that have a significant patient and social impact for which current therapy is lacking or in need of improvement. Reponex’s business model and drug development strategy consists of repositioning, rerouting, and recombining different established drugs and finding new use for it. Below you can read about the disease indication that currently are in the scope of Reponex Pharmaceuticals or follow the link below to enter the website of Reponex.
Bacterial Peritonitis
The aim of this project is to improve the treatment of incipient or established peritonitis (inflammation of the lining of the abdominal cavity) as a consequence of appendicitis or other intestinal perforations, thereby significantly improving survival and reducing morbidity and the duration of hospitalization. Following a successful preliminary acceptability and safety study, an explorative clinical trial in patients with ruptured appendix has also been successfully completed.
Our clinical proces
RNX-011 is a combination of 3 active pharmaceutical ingredients (API). In a preliminary clinical proof of concept study in patients with perforated appendicitis undergoing laparascopic appendicectomy, the addition of RNX-011 to standard of care (SOC) was associated with a shorter hospital stay (13 hours in the RNX-011 group versus 84 hours in the SOC group) and a trend to quicker return to normal activities (6 days in the RNX-011 group versus 10 days in the SOC group (1). In addition, there were no complications in the patients receiving RNX-011, whereas two cases of intra-abdominal abscess (localised infection in the abdominal cavity) occurred among patients receiving standard of care.
To read more about the rationale for developing RNX-011 for bacterial peritonitis click “read more” below.
Rationale for developing treatment for bacterial peritonitis
Peritonitis is an inflammation of the peritoneum, the epithelium that lines the abdominal cavity. The inflammation can occur either locally or diffusely in the abdomen. The severity of the disease is closely related to the extent of the inflammation. A local inflammation (as seen in uncomplicated appendicitis) is a less severe disease than diffuse peritonitis (e.g., secondary to a perforation of the colon with faecal contamination throughout the abdomen). In the latter case, peritonitis can have long-term adverse consequences for the patient even with the best current treatment options. Current practice for both local and diffuse peritonitis is surgical intervention and with intravenous (systemic) administration of antibiotics.
RNX-011 is a new combination and new route of administration of drugs to treat peritonitis as an add on to current standard surgical intervention. RNX-011 is administered intraperitoneally, i.e, directly into the abdominal cavity, thereby achieving the highest drug concentrations at the site of infection.
- Incidence of primary indications: 1.7 million per year worldwide (586,000 per year EU+US)
- Incidence of secondary indications: 855,000 per year worldwide (463,000 per year EU+US)
Wound Healing /Chronic Skin Ulcers
Chronic ulcers in the form of venous leg ulcers and diabetic foot ulcers are a worldwide problem to the great inconvenience of the affected patients.
There are several categories of non-healing wounds and ulcers, each of which has its own specialised treatment. These treatments include debridement of necrotic tissue, infection control and local wound care. However, non-healing wounds and ulcers have in common that they are typically caused by a deficiency in local blood supply, which fails to provide the nutritional means of keeping the cells involved in healing fully active. White blood cells (neutrophils) and macrophages fail in their housekeeping functions, and the macrophages fail to provide their normal stimulation of repair functions.
Reponex has several drug candidates in development for the treatment of non-healing wounds. To read more about wound healing click “read more” below.
Rationale for developing treatments for wound healing
Chronic skin wounds are typically associated with diabetes, venous insufficiency, local pressure, or vascular disease. Common to these is a lack of local blood supply, which impairs the provision of the substances that are necessary to maintain full activity of the cells involved in the healing process. The white blood cells and macrophages do not perform their functions adequately, and the macrophages do not stimulate the healing processes as they normally would. By treating chronic wounds with Reponex formulations, the cleansing functions of the macrophages should be restored, improving the removal of bacteria and dead tissue and accelerating wound healing.
Combination with other healing-promoting agents, RNX-022: Reponex is investigating the combination of immune stimulating agents with other wound-healing promoting agents to further enhance the healing process. These include agents that promotes the synthesis and assembly of key extracellular matrix components such as interstitial collagens during wound healing, and agents that amplifies the effects of intrinsic cytokines and growth factors involved in wound repair, e.g. basic fibroblast growth factor, by binding them and protecting them from degradation, so their effect on the wound healing process is prolonged. These agents are expected to exert additive and synergistic effects through different but complementary mechanisms of action, to exert an optimal effect on wound healing.
Combination with antibiotics, RNX-023: Bacteria are present in all chronic wounds, but more than 16% of the wounds may in certain stages be more aggressively infected by pathogenic bacteria such as Staph. aureus and/or P. aeruginosa. While strengthening local immune cell response is critical for wound repair, the addition of antibacterial agents to eliminate bacterial biofilms is expected to further enhance the speed wound closure, when there is evidence of wound infection. Reponex preferred antibiotic is particularly suitable since its broad spectrum covers most of the relevant pathogenic organisms, including methicillin-resistant S. aureus (MRSA), multidrug-resistant bacteria
and many common strains of P. Aeruginosa.
- Prevalence of chronic leg ulcers: 47.9 million worldwide (13.9 million in EU+US)
- Incidence of infected chronic leg ulcers: 7.2 million per year worldwide (1.5 million per year in EU+US)
Inflammatory Bowel Disease
Pouchitis
A special group of patients having had previous surgical removal of their large bowel for ulcerative colitits, suffer from a chronic inflammation of the pouch constructed from the terminal ileum to allow normal defecation. This inflammatory condition is called “pouchitis”. Pouchitis causes great pain, very frequent toilet visits and often significantly reduced quality of life for the patients.
A preliminary clinical trial of RNX-041 in the treatment of pouchitis is ongoing at Zealand University Hospital. The study will provide invaluable data for the design and execution of the subsequent placebo-controlled trials of RNX-041.
A clinical phase II trial on RNX-041 for the treatment of pouchitis is ongoing at Zealand University Hospital. The study will provide invaluable data for the design and execution of the subsequent placebo-controlled trial of RNX-041 for Crohn’s Disease.
Crohn’s Disease
Reponex seeks to improve on the current treatment of Crohn’s disease through the development of RNX-041. RNX-041 is applied directly onto the affected areas via a spray catheter that can be directed to the target area through the endoscope used for localisation of the lesions. Applying RNX-041 locally from the intestinal lumen to the areas of inflamed and damaged mucosa has the potential to restore the impaired mucosal barrier and local macrophage function without provoking systemic inflammatory effects. At the same time, the local application of the antibiotics in RNX-041 can reduce the load of intestinal bacteria that trigger and sustain the abnormal inflammatory response. To read more about Crohn’s disease and pouchitis click “read more” below.To read more about Crohn’s disease and pouchitis click “read more” below.
Rationale for developing treatment for Crohn’s Disease
The principle of the treatment is to supply RNX-041 locally to the inflamed areas of the intestinal mucosa from the intestinal lumen. The rationale is that this route of administration optimises a favourable local effect of RNX-041 which acts to restore the disrupted mucosal barrier without provoking an augmented systemic inflammatory response (with an unfavourable activation of unwanted immune cells such as eosinophils and basophils). Similarly, high local concentrations of broad-spectrum antibiotics attenuate the pathogenic influences from the intestinal flora, especially from the Enterobacteriaceae and B. fragilis group of organisms that are suspected of exacerbating Crohn’s disease.
- Prevalence of Crohn’s disease: 2.75 million worldwide (1.75 million in EU+US)
- Incidence of pouchitis: 235,000 per year in EU+US
Colorectal Cancer
It has recently been discovered that generation, growth and spread of colorectal cancer tumors are promoted by certain bacteria in the large bowel. These include toxin-producing fusobacteria that organized in biofilms which invades the surface mucous layer of the bowel. Some of these bacteria also infect bowel cancers, where they have been shown to promote the growth of these tumours and make them more resistant to treatment with radiotherapy and chemotherapy.
Reponex is developing drug formulations as an innovative method of reducing or eradicating these cancer-promoting bacteria in the bowel, A preliminary clinical study of RNX-051 at Zealand University Hospital has completed enrolment, and results are expected by the end of year, 2023. To read more about CRC treatment click “read more” below.
Rationale for developing RNX-051 for colorectal cancer
Fusobacterium is a genus of Gram-negative anaerobic bacteria, species of which, including F. nucleatum, are found in the oral cavity, where they play a role in periodontal disease. Genomic sequences of fusobacteria have been found to be enriched in colorectal cancer tumors, with a prominence of DNA sequences related to F. nucleatum. An overabundance of F. nucleatum RNA was also detected in such tumors. Fusobacteria target colorectal adenocarcinoma cells by means of their Fap2 lectin, which specifically binds to the D-galactose-β(1-3)-N-acetyl-D-galactosamine (Gal-GalNAc) residues of the surface carbohydrates of colorectal and certain other adenocarcinomas. Once in the tumor, the fusobacteria invade the cells and can enhance cellular proliferation, create a tumor-favourable inflammatory environment and protect the cancer cells against killing by natural killer cells and tumor-infiltrating T cells. F. nucleatum also promotes the resistance of colorectal cancers to chemotherapy, and because similar cellular mechanisms are involved, to radiotherapy. High fusobacterial abundance in colorectal cancer correlates with poor disease outcome. At the same time, there has been a call for antibacterial agents targeted specifically to fusobacteria to avoid the adverse effects of systemically administered broad-spectrum antibiotics.
Fusobacteria are highly sensitive to specific antibiotics. Local administration of the antibiotic via the bowel lumen, will result in a very high antibiotic concentration at the luminal surface, and achieves high levels within intestinal mucosa cells, where the fusobacteria are located. Thus local delivery of the drug achieves high bacterial killing concentrations within the bowel mucosal cells while minimizing systemic exposure and the risk of side effects.
Quantitative polymerase chain reaction analysis of F. nucleatum DNA in the tumors demonstrates that the bacteria are concentrated in the superficial, luminal portion of the tumors. Therefore, antibacterial treatment by applying a high concentration of the antibiotic from the luminal side should be particularly effective in eliminating the bulk of the bacterial load.
- Incidence of colorectal cancer: 1.9 million per year worldwide (586,000 per year EU+US)
New Drug Delivery Platform
In parallel with the development of RNX-041, it has been important for Reponex to develop a concept for administration of the active substances for the treatment of intestinal lesions in the form of an oral drug, so that patients can receive treatment daily comfortably and without significant inconvenience.
Reponex has been developing a new concept and technology that entails the targeting of the active ingredients in RNX-041 and possibly other biological agents directly to the intestinal lesions, by binding the agents to known and approved substances that in themselves bind selectively to the lesions and prolong the contact of the biological agents with the ulcer bed. RNX-042 is to be administrated orally by a gel forming substance protecting the biological agents until reaching the terminal ileum where the gel dissolves and releases the active ingredients. To read more about new drug delivery platform click “read more” below.
Providing local intraluminal intestinal treatments by means of oral formulation.
Two main concepts are being studied that can be used individually or in combination to target the drugs to the intestinal lesions in Crohn’s Disease:
- Adsorption (surface binding) of the fragile but important active protein in Reponex’s medicinal drug, which builds the integrity of the intestinal mucosa, into a known ulcer-treating particle product that binds the protein, protects it from the breakdown of stomach acid and digestive enzymes, binds to defects in intestinal mucosa and enhances the action of the adsorbed protein.
- Dissolve the active substances in a small amount of a thin liquid containing substances which form a soft gel lump when the liquid is swallowed and comes into contact with the stomach acid. The drugs remain significantly inside the gel, thereby protecting against the full effect of stomach acid and digestive enzymes. The gel is transported down the intestine, but is broken down again in the transition from the small intestine to the large intestine, thus triggering the drugs. This could prove to be suitable for the treatment of Crohn’s lesions in the terminal small intestine and / or the subsequent part of the large intestine. Preliminary studies so far indicate a satisfactory incorporation of the API into the gel when it is formed in contact with simulated gastric acid.
Reponex attaches great importance to the development of these possible oral treatments for intestinal lesions, as thy are expected to enable the performance of what is actually a local treatment that would most often require invasive endoscopy, as a convenient oral treatment for daily use.
Through the development work with RNX-042, this dynamic gel concept has proven to be particularly suitable for the delivery of particle preparations further down the intestine, including probiotic bacteria, which is also specified in the filed patent application.
Reponex’s innovative drug administration platform opens up completely new possibilities for local targeted treatments in the gut, which go far beyond Reponex’s current development program.
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