Research and development
of pharmaceutical products
and medical devices


Iperboreal Pharma Srl

Iperboreal Pharma S.r.l., established in 2003, is a pharmaceutical company engaged in the research and development of pharmaceutical products and medical devices.
The management and advisory team of Iperboreal Pharma possess extensive experience in all areas of pharmaceutical product and medical device research and development.

SPECIFIC AREAS
OF INTEREST

 Peritoneal Dialysis
End-Stage Renal Disease
Refractory Congestive Heart Failure

Our Strategy

The strategy we employ at Iperboreal Pharma is to develop a structure that minimizes infrastructure costs and maximizes access to scientific knowledge and research in the biomedical field.

All conceptual phases are carried out within Iperboreal Pharma (identification of new therapeutic targets, preclinical pharmacology, engineering, prototyping, etc.), while those supporting precompetitive industrial development are realized through commercial agreements with specialized service companies in the relevant sectors.

An important aspect of this strategy concerns accessing Community (H2020) and national (F.I.T., F.A.R., PIA, Regional Funding) financing programs.

At Iperboreal Pharma, we are convinced that essential elements of a successful industrial research strategy are knowledge and basic research.

Objectives

Our goal is to develop research programs up to a precompetitive industrial development phase, enabling us to establish commercial agreements (licensing, co-development, transfer, etc.) with multinational companies operating in the pharmaceutical and biomedical instrumentation sectors.

This approach significantly reduces the time required for our product to generate real profit and benefit for the community. It is also clear that achieving our goal involves intense intellectual property protection activities (patents), which represent the true assets of any company engaged in research programs.

Furthermore, we can provide the services of a preclinical Contract Research Organization (CRO), offering the expertise, know-how, and professional skills needed to take a drug or medical device from the drawing board to the market.

Why "Iperboreal"

An ancient map depicting the island of Thule, known in ancient Greece as the legendary land of the Iperboreans. In ancient maps, Thule was commonly located to the northwest of England and Ireland or in the northernmost area of Asia.

But what does the myth of the Iperboreans have to do with the pharmaceutical industry? Solutions to health problems are a reward sometimes reserved only for those who are not afraid of uncharted paths. In the demanding pharmaceutical reality, the myth of the Iperboreans, a people inclined without fear towards the discovery of new worlds, inspires us to defend the dream, like the infinite shadow of the truth.

"Not by land or by water will you find the (wondrous) path that leads to the Iperboreans."
Pindar

Our Areas of Interest

Peritoneal Dialysis

Peritoneal dialysis follows the same physicochemical principles as hemodialysis, with the difference that the semipermeable filtration membrane is a biological membrane: the removal of toxins and water occurs through the patient's peritoneal membrane, a membrane that lines the abdominal organs. The patient's abdomen is filled with dialyzing fluid, a solution specifically formulated to act as a peritoneal dialytic solution.

Even for less osmotically active solutions, the peritoneal dialytic solution contains a significant amount of glucose and physiological quantities of sodium, calcium, and magnesium. After 4 years of treatment, the presence of glucose in the dialyzing fluid, necessary to remove water through osmotic processes, damages the peritoneal membrane through fibrosis, progressively reducing its permeability and filtration capacity.

Furthermore, during heat sterilization, glucose degrades, releasing highly reactive substances that inhibit cell proliferation and cause necrosis of fibroblasts, macrophages, and human mesothelial cells in vitro. These toxic actions could accelerate the peritoneal fibrosis process.

Moreover, glucose absorption, to a greater or lesser extent, is always associated with metabolic disorders such as hyperglycemia, hyperinsulinemia, hyperlipidemia, and obesity.

Innovative Solutions

By collaborating with a significant company operating in the field of home therapies, at Iperboreal Pharma, we are developing a portfolio of hypertonic solutions for peritoneal dialysis that are more biocompatible, better tolerated by the peritoneal membrane, and contain less glucose. In fact, a series of in vitro and in vivo studies have demonstrated the superior biocompatibility of our developing hypertonic solutions compared to those exclusively glucose-based.

The presence of carnitine and xylitol as active osmotic agents allows for a significant reduction in the amount of glucose in the dialysis solutions, as well as an improvement in the altered glucose and lipid homeostasis found in diabetic and insulin-resistant patients undergoing peritoneal dialysis.

End-Stage
Renal Disease

End-stage renal disease (ESRD) occurs when a gradual loss of renal function reaches an advanced stage and kidneys are no more able to sustain a sufficient fluid and waste removal.
The leading cause of ESRD is diabetes, that accounts for approximately 35% of newly diagnosed cases, followed by hypertension (30%) and other diseases such as secondary glomerulopathies, cystic and interstitial renal diseases and obstructive uropathy. Chronic renal failure has emerged as one of the leading noncommunicable causes of death, with a population of 500 million of patient worldwide (in growth), among which more than 2 million are under dialysis treatment.

Our development program focuses on Peritoneal Dialysis (PD), one of the limited options available for renal replacement, where we are innovating those hypertonic solutions that are required to carry-on the dialytic process. Our new solutions contain a reduced amount of glucose, associated with naturally occurring agents. The osmolar property of the solution, and hence the ability to achieve a satisfactory filtration process across the peritoneum, is ensured by the presence of new osmolar agents that possess an excellent biocompatibility profile and are also capable to exert a significant systemic action in mitigating conditions such as insulin resistance and hyperglycemia. We refer to our approach as a “glucose-sparing and osmo-metabolic” peritoneal dialysis, opposed to the traditional “glucose-based” one.

Our most advanced product is in clinical development ad reached the phase III (EudraCT: 2019-004183-21). 

Causes of Chronic
Kidney Disease

Diabetes mellitus is the leading cause of end-stage chronic kidney disease, accounting for about 35% of new cases diagnosed, followed by hypertension (30%).
Other causes of end-stage chronic kidney disease include primary and secondary glomerulopathies, cystic and interstitial kidney diseases, and obstructive uropathy.
Untreated end-stage chronic kidney disease is irreversible and lethal.
The life expectancy of adult individuals affected by this renal condition is less than 10 years, making it similar to other chronic diseases like cancer.
End-stage chronic kidney disease is a significant public health issue that could become unsustainable in the next 10 years.

Addressing Chronic
Kidney Disease

The only possible solutions for treating individuals with end-stage chronic kidney disease are kidney transplantation or dialysis.

Kidney transplantation cannot be considered a comprehensive solution due to the limited number of donors, compatibility issues, and high incidence of short-, medium-, and long-term failures due to hyperacute, accelerated acute, and chronic rejections.

Currently, the majority of patients must undergo dialysis: hemodialysis or peritoneal dialysis.
Hemodialysis involves a session during which a machine, referred to as an artificial kidney and equipped with a semipermeable membrane capillary hemofilter, removes toxins and excess water from the patient's blood. Hemodialysis patients typically require dialysis three times a week for 3-4 hours per session.

REFRACTORY CONGESTIVE
CARDIAC FAILURE

Congestive Heart Failure (CHF) is a condition where the heart is not able to provide a sufficient perfusion to meet body demands, causing a decreased renal function and thus leading to fluid accumulation in lungs, abdomen, liver and lower body. CHF patients are fatigued, dyspnoeic, unable to carry out physical exercise without discomfort and exerting typical symptoms even at rest. Furthermore, a consistent amount of patients (40%) become refractory to the conventional medical therapy and with the progression of the pathology they have no other therapeutic option then end-of-life hospice care. Beside the human burden, HF heavily impact the society, with a high and growing population (almost 7 million in US) and generating the largest expense in medicare (53bn$ of direct costs forecasted for 2023). Most of these costs (80%) are due to hospitalizations, whose most frequent cause is, indeed, congestion.

The key to improve patients’ life and societal burden is achieving a functional and lasting fluid disposal, which could alleviate patients’ symptoms and guarantee a higher quality of life, while decreasing the need for hospital and private care. Our experience in peritoneal dialysis innovation allowed us to start developing a therapeutic platform for congestive heart failure. Here, we aim to achieve a long-standing fluid disposal by peritoneal ultrafiltration performed with Polycore, one of our bioactive and glucose-sparing innovative solutions.


Our therapeutic proposal desired outcomes are:
Fluid unloading – peritoneal ultrafiltration is a home-based therapy able to guarantee a significant fluid disposal which should alleviate congestion symptoms thus limiting the necessity for hospital resources.

Preservation of renal function – peritoneal ultrafiltration better preserves kidney function if compared to other kidney-replacement therapies. Moreover, the limitation of glucose uptake further spare kidney function due to a decreased effort in reabsorbing sodium.

Preservation of peritoneum function – Polycore is developed to be highly biocompatible. the limitation of intra-peritoneal glucose and the presence of bioactive agents preserve the peritoneum and guarantee a longer therapy life, which is vital to assure continuity to patients’ needs.

Mitigate comorbidities – an inadequate glycemic control and insulin signaling may lead to heart failure and comorbidities progression. The limitation of glucose uptake and the favorable metabolic effects of bioactive agents contributes to a better glycemic and insulin control.

Our most advanced product is in clinical development ad reached the phase II (EudraCT: 2019-004670-25).

Pipeline

Our Publications

GlucoThera: glucose-based PD solutions (CAPD/APD)
GlucoThera Low Sodium: low-sodium glucose-based PD solutions (CAPD/APD)
GlucoThera Plus: glucose-based PD solutions for carnitine deficiency (CAPD/APD)
XyloThera: osmo-metabolic-based PD solutions (CAPD/APD)
PolyCore: osmo-metabolic and colloidal-based Ultrafiltration solution (CAPD)

Medical Devices

At Iperboreal Pharma, we are also committed to the research and development of medical devices for peritoneal dialysis. Our hypertonic solutions will be accompanied by a range of devices that form an integrated therapeutic system utilizing the best technologies to provide a safe and personalized peritoneal treatment.
Through the use of a modular cycler, it will be possible to offer a new therapeutic approach that adapts to the patient's physiological needs in real-time by continuously monitoring specific parameters that gauge the effectiveness of the ultrafiltration technique and provide feedback to both the patient and the physician about the progress of the therapy.

Furthermore, we are engaged in the development of new user-friendly connection systems capable of facilitating aseptic fluid exchange, thus protecting the patient from potential contamination due to environmental bacterial agents that could lead to risky peritonitis.

Via L'Aquila 9 / 65121 Pescara ITALY
Tel. +39 085 2034834  -  info@iperboreal.com

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