Verici Dx (VRCI ) said patient enrolment for a multi-centre observational clinical validation study for the Company's lead products has concluded ahead of management expectations.
Having completed its enrolment early, the developer of advanced clinical diagnostics for organ transplants remains on track to complete the validation study for these products by the end of 2021, in line with expectations set out in the Company's admission document.
Verici Dx has partnered with eleven leading US and EU centres to date to run a global, non-randomised study for the clinical validation of its lead 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.
The study uses next generation sequencing in the Verici Dx lab to create transcriptomic profiles to validate performance characteristics of the lead Verici Dx signature tests.
Over the longer term, the study will also provide validation for a fibrosis test called Protega™. The patient enrolment process for Protega which is ongoing is expected to complete by 3Q22.
The end points of the study for this product are expected to be reached up to two years after the completion of enrolment, with data expected shortly thereafter around year-end 2024.
Commenting on the clinical validation study, Sara Barrington, Chief Executive Officer of Verici Dx, said: "I am delighted to have reached this key milestone ahead of our original expectations. Since IPO our primary focus has been on the successful prosecution of these clinical trials, as the first key step in commercialising our innovative transplant products.
She added, “We remain on track to have our two lead products fully tested by the end of the year and look forward to reporting the data in Q1 2022."
View from Vox
In recent weeks, Verici obtained a “major milestone” certification which will authorise it to initiate commercial operations as a diagnostic lab in Tennessee in the United States.
The lab at the Innovation Park in Franklin, Tennessee, which was signed for in April, is located in the Palmetto region, one of the largest Medicare administrative contractors in the US.
At the time, the new space marked the first step towards Verici Dx achieving the necessary CLIA approvals for its commercial launch of its leading products, Clarava™ and Tuteva™.
Back in January 2021, Verici unveiled plans to accelerate a CLIA approval strategy in otfrt to bring forward this commercial launch with the appointment of David Schultenover as Vice President of Quality and Regulatory who is to project manage this key objective for 2021.
In July, Verici Dx expanded the 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.
Verici Dx also unveiled its collaboration with three leading US centres for clinical validation trial of its lead products back in March 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.
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.
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
Verici Dx’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.
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.
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 Verici Dx.
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