Verici Dx (VRCI ) has expanded its clinical validation of two of its lead assets by initiating its first European clinical validation trial site at the Sant'Orsola Polyclinic Hospital in Bologna.
The Group, which develops advanced clinical diagnostics for organ transplants, said it will work in partnership with Professor Gaetano La Manna, Director of the Specialization School in Nephrology and the Dialysis and Transplant Unit at the hospital which is in Bologna, Italy.
The trial is a global, non-randomised, observational study for the clinical validation of Verici Dx's lead products; Clarava™, which predicts the risk of early acute rejection in the first six months post-transplant, and Tuteva™, which diagnoses acute cell-mediated rejection. Over the longer term, the trial will also seek to validate the Group’s fibrosis test called Protega™.
The Company told investors that this recent work alongside Prof. Gaetano La Manna forms part of its efforts to expand its clinical development and validation beyond North America.
Prof. La Manna, has extensive experience in both clinical and experimental nephrology, dialysis and kidney transplantation, as well as in kidney transplants and its complications.
The Kidney Transplant Center of the University of Bologna which is located inside the IRCCS Sant'Orsola Polyclinic Hospital in Bologna, is one of the most important in Europe for number, quality and complexity of transplants, with more than 3,000 to its credit, Verici Dx explained.
This includes donation after brainstem death (DBD), donation after circulatory death (DCD), marginal donor, double transplants, ABO incompatible, hyperimmunized patients, combined kidney-liver, kidney-heart transplants and other special programs, the Group outlined.
Verici Dx unveiled its collaboration with three leading US centres for clinical validation trial of its lead products back in March 2021 and has subsequently opened 2 more US centres.
To date, enrolment is on target for completion of the Clarava and Tuteva validation study by the end of 2021 with data expected to be published ‘as soon as practicably possible’ in 2022.
Commenting on the news, Angela Rose, Senior Director of Clinical Trial Operations of Verici Dx, said, "The team has worked incredibly hard on this project, from designing and developing the approach to implementing the trial. The diversification of our patient sample is a strategically important initiative for Verici, as we seek to leverage our clinical expertise and demonstrate our commitment to the development of globally validated transplant diagnostics."
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Back in April 2021, Verici, which develops clinical diagnostics for organ transplants, signed the lease for the lab with one of the largest Medicare administrative contractors in the United States, for CMS (Center for Medicare and Medicaid Services) Medicare governance.
At the time, Verici said the new space, which it said was to be situated at the Innovation Park in Franklin, Tennessee, would mark the first step towards the firm achieving the necessary CLIA approvals ahead of the commercial launch of its products, Clarava™ and Tuteva™.
The Group’s Clarava™ assay is a pre-transplant prognosis test for the risk of early acute rejection, while Tuteva™ is a post-transplant diagnostic focused upon acute cellular rejection.
Its efforts to accelerate the use of its organ transplant products comes at a time when the landscape of solid organ transplantation has dramatically changed as a result of COVID-19.
While developing, trialling and obtaining the necessary regulatory authorisations before launching medical technologies can be a lengthy process, Verici said it is focused on compressing these timescales with the aim to commercialise its kidney tests in 2022.
Shares in Verici Dx have increased by over 25% in value since the beginning of the year. The stock was trading 0.68% higher today at 74.5p immediately following the announcement.
Reasons to VRCI
Verici Dx is focused on developing and commercialising tests to understand how a patient will and is responding to organ transplant, with an initial focus on kidney transplants.
Leading IP
The Company’s work is underpinned by extensive scientific research into the recipient's immune phenotype and how that impacts on acute rejection, chronic injury and ultimately failure of the transplant.
Meanwhile, the company’s immuno-profile signatures also inform clinicians as to the optimal strategy for immunosuppressive and other therapies for the most successful treatment to ensure graft acceptance with the least amount of side effects.
Verici Dx was admitted to trading on AIM on 3 November 2020, with the company also raising £12.05m through an oversubscribed fundraising, to primarily fund the development and commercialisation of its two leading clinical products in the kidney transplant space.
Significant Market Opportunity >$600m p.a.
The waiting list for transplants is significant at around 300,000 globally with US and European governments calling for an acceleration in the number of transplants undertaken each year.
Globally, there are approximately 95,000 transplants per annum, of which approximately 24,000 and 25,000 are performed in the US and Europe respectively.
In the US the average cost of a transplant is $0.44m per transplant and the average annual cost of dialysis is around $0.09m, with patients faced with being on dialysis from 3 to 5 years.
Positive Development Newsflow
Verici aims to commence a multi-centre validation study for each product in 4Q20, with studies expected to conclude in 4Q21. Clarava and Tuteva are then expected to be offered as Lab Developed Tests with regulatory approval with first revenues expected during 2022.
Verici expects supportive news flow throughout 2021 on commercial partnerships, regulatory news, reimbursement and results from test development programmes. Once approved, it aims to accelerate reimbursement coverage ahead of full clinical utility data in 4Q22.
Last month, Verici expanded the scope of an existing licence agreement to include an additional patent filing related to the analysis of gene expression in a blood-based test (liquid biopsy) to predict risk of fibrosis (chronic kidney graft damage) and rejection of the graft.
The development of a product that can predict risk of fibrosis and rejection using Verici’s core technological approach would extend its portfolio across the full course of a patient's transplant journey and complement its two in vitro diagnostic assays, Clarava and Tuteva.
The development of a product that can predict the risk of long-term graft failure, alongside our flagship products Clarava™ and Tuteva™, would establish an end-to-end solution for clinicians seeking to understand how a patient will and is responding to organ transplant.
There is a critical need for more personalised diagnostic information within transplant care, and in particular technologies informing earlier interventions with anti-fibrotic therapies in advance of irreversible organ damage,” commented Sara Barrington, CEO of the licence.
Verici said it will provide more information on its development and commercialisation plans in its results for the financial year ended 31 December 2020, which it expects to release in April.
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