2022-10-001 - FIBROKIT-2 - IVD-based non-invasive detection & monitoring of kidney fibrosis

FIBROKIT-2

2022-10-001

A dual approach IVD tests for RF (a qualitative “point-of-care” lateral flow kit and a quantitative ELISA kit for clinical labs). FIBROKIT will contribute to drastically reduce underdiagnoses, help doctors to preserve kidney function of patients at risk of developing end-stage renal diseases and, therefore, reduce the important social and economic burden associated with CKD.

To date there is no commercially available non-invasive test to evaluate and monitor RF and our tests could benefit patients diagnosed/in risk of CKD, patients with chronic metabolic pathologies, cardiovascular patients, aged people and kidney transplant patients. The assets will be cost-effective and could be implemented regularly in the clinical practice, which in turn may help to reduce the burden of biopsies and kidney replacement treatments of CKD patients. Besides, assets may be of interest of pharmaceutical companies developing antifibrotic drugs as non-invasive test for clinical studies.

CKD is on track to become the leading cause of death in the forthcoming decades. Moreover, cost studies place it above cancer and diabetes in terms of healthcare expenditure. Delivering early and efficacious diagnosis is paramount in reversing these alarming trends. Only 1% of people suffering from CKD are aware of their condition. This fact is translated into a high rate of underdiagnosed and untreated CKD patients, who are at risk of developing an end-stage kidney disease requiring replacement therapy. Improved monitoring of RF (the main factor for CKD evolution) with FIBROKIT may help to reduce these figures, contributing to prolong kidney function. FIBROKIT may allow frequent, non-invasive monitoring and treatment management of CKD patients (including kidney transplant patients) and patients at risk of developing RF due to other pathologies, with a positive impact on patient management and a reduction in healthcare associated costs. Our solutions may also help to drastically reduce the high rate of underdiagnosed patients at risk and help select objectively patients eligible for biopsy. Providing more efficient and frequent monitoring of patients will help to better Personalize Medicine, which will undoubtedly contribute to patients’ quality of life. Moreover, our assets may also help pharmaceutical companies performing clinical trials for novel anti-fibrotic drugs. By easing patients monitoring, FIBROKIT may contribute to fasten the development of new drug formulations for renal fibrosis.

Chronic kidney disease (CKD) is a major health problem affecting approximately 15% of the world's population. CKD silently evolves to kidney dysfunction and failure, which ultimately requires high cost and invalidating kidney replacement therapies (e.g. dialysis and transplantation). The main responsible of CKD progression is the silent and gradual accumulation of extracellular matrix in the kidneys, referred as Renal Fibrosis (RF). Although many efforts are being made, to date there is still no cure for CKD. However, prevention and early detection can help to slow or halt the progression of RF. Current analytical parameters do not reflect fibrotic lesions and the "gold standard" for RF diagnosis is renal biopsy (RB), an invasive procedure with major limitations precluding an optimal patient monitoring. Therefore, we are developing FIBROKIT, the first IVD tests for diagnosis and monitoring of RF. A dual diagnostic approach, based on a solid and easily scalable technology, for a precise, repeatable and patient-friendly solution that may overcome most of the drawbacks of RB. FIBROKIT approaches will help to reduce the number of underdiagnosed patients and better monitorize patients at risk of developing end-stage renal disease, contributing to prolong their kidney function and quality of life.

850000000

19600000

3500000

Our business model is a B2B, B2A and B2B2C omnichannel pay-per-kit, offering an ELISA test designed for laboratories and a rapid Lateral Flow test for immediate use that is also compatible with commonly used diagnostic reading devices. FibroKit can deliver significant benefits to hospitals, clinics, national healthcare systems, and even patients online, facilitating early diagnosis and ongoing monitoring of the disease. The right distribution agreements will be instrumental in ensuring FibroKit's succes.

More than 100 million CKD patients only in EU and USA, the important association between CKD and chronic pathologies, and a worsening projection on CKD incidence show that there is a clear unmet need to address. There are two main challenges to solve, the incapacity of early detection of RF and the lack of non-invasive, precise and objective methods for monitoring RF.

Our potential market is 15% of the world's population with an expected sector anual growth of 7%. The bulk of these prospective users are located within European and North American hospitals and clinics, markets where diagnostic testing is experiencing a strong growth.

We need an initial 500K€ to build our team, covering areas of business development, technical validation of prototypes, product optimization, as well as advance regulatory submissions and clinical trials. Afterwards, we anticipate a seed funding requirement in the range of €0.8-1.2M to reach a state of market readiness.

Financing

Spin-off constitution

FIBROKIT, is aimed to be a non-invasive test based on the detection of urinary VTN by specific proprietary monoclonal antibodies. Fibrokit is conceived as a dual platform biomarker test: i) a lateral-flow qualitative test for screening and ii) an ELISA test for quantitative definition of VTN levels. Beyond the use of FIBROKIT for screening and monitoring Kidney transplant patients and other population at risk of suffering severe CKD (i.e. aged people, cardiovascular, metabolic & chronic patients), our solution may be also of interest for companies developing anti-fibrotic drugs as an alternative read-out to RB in clinical monitoring. Also for assessing the potential induction of renal fibrosis by new or current drugs or treatments. Our assets may be also applied to evaluate the fibrotic level of donor grafts before transplantation, increasing the quality of their monitoring.

Technological risks: Reproduce PoC with our own prototypes and Biopsy as gold standard to compare. Financial: Fail to attract investors/agencies and Lack of financial support Market determinants: Clinicians reluctance, Difficult to replace current endpoints , Costs for NHS and Lack of actionability due to lack of anti-fibrotic drugs Regulatory environment: Newly implemented EU regulations for IVD products

Fibrokit has already made significant strides thanks to competitive funding. We've successfully identified our key biomarker, validated our technique across numerous cohorts, and secured our innovations with robust patent protection. Our regulatory strategy, with the assistance of Asphalion, is clear and in place. We've also completed favorable HTA studies in collaboration with FHiTT and a promising preliminary FTO study. We are currently developing our propietary antibodies and designing our prototypes. We still need to evolve our prototypes into final ELISA and Lateral Flow products, advance to manufacturing, execute clinical validation, and secure CE and FDA approvals. Simultaneously, we're developing a ResearchUseOnly variant of the product to drive commercial interest. Our next steps also involve establishing Fibrokit as a spin-off entity and setting it on a professional trajectory to raise funds for a seed round by the end of 2025.

Our assets are protected with a patent application published as WO2021/130138 (PCT/EP2020/087290), with priority date of 23 December 2019). The Written Opinion of the Searching Authority (WO/ISA) stated that claims expressed in the PCT are Novel, Inventive and of Industrial Applicability, thus the application entered national phases and extended in EU, US, Canada and Mexico. This application claims methods for using vitronectin for the screening, diagnosis or monitoring of kidney fibrosis in a subject, the classification of a subject according to its degree of kidney fibrosis, and a method for determining prognosis on the basis of the degree of kidney fibrosis.

NO

NO

Patents: WO2021130138 - Date: Jul 1st, 2021 Status: Granted URL: https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2021130138

Based on a technology that fits current clinical practice (monoclonal Antibody specific detection), Fibrokit would allow non-invasive and frequent screening and monitoring of CKD patients and/or patients at risk of developing RF due to other chronic and highly prevalent pathologies (e.g. diabetes or hypertension). This way, FIBROKIT will contribute to drastically reduce underdiagnoses, help doctors to preserve kidney function of patients at risk of developing end-stage renal diseases and, therefore, reduce the important social and economic burden associated with CKD.