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Verici Dx initiates first US clinical trial sites for Clarava™ and Tuteva™

10:52, 2nd March 2021
Francesca Morgan
Vox Newswire
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Verici Dx (AIM: VRCI FOLLOW) has partnered with three leading US medical organisations in order to initiate the first US clinical trials for its two lead products, Clarava™ and Tuteva™.

The Group unveiled that it has partnered with Dr Lorenzo Gallon at Northwestern University Feinberg School of Medicine, Dr Milagros Samaniego at Henry Ford Health System and Dr Daniel G. Maluf at the University of Maryland, Baltimore to collaborate on the trial.

The trial will use next generation sequencing in the Verici lab to create transcriptomic profiles to validate performance characteristics of the Group’s lead products, Clarava™ and Tuteva™. In the longer term, Verici also hopes to work on the validation of its fibrosis test.

Verici’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. 

Verici recently said that it was accelerating its Clinical Laboratory Improvement Amendments approval strategy to bring forward the commercial launch of the products.

This forms part of its efforts to accelerate the use of its organ transplant products at a time when the landscape of solid organ transplantation has dramatically changed as a result of COVID-19.

Although the Centres for Medicare and Medicaid Services has categorised solid organ transplantation as an urgent procedure, the majority of transplant centres in the US have reduced the numbers of kidney transplant procedures in response to the ongoing pandemic.

An estimated 37 million people in the US have chronic kidney disease, failure (c. 750k) &/or require transplants – with the Medicare system alone spending $130bn pa in treatment. 

The Nature Reviews Nephrology wrote that the pandemic “has disrupted transplant referral and listing processes, led to decreases in the numbers of transplant procedures and resulted in changes in practice for pre- and post-transplantation management and follow-up.”

Commenting on this latest partnership in the US, Sara Barrington, Chief Executive of Verici Dx said, "We are delighted at the level of global interest in our validation trial and highly appreciative that these centres were able to lead our first clinical trials in the United States.”

“Lorenzo, Milagros and Daniel have excellent, demonstrable track records in the medical industry, and have collectively helped pioneer organ transplant research in the modern era. 

We are excited to be onboarding more US sites shortly and are currently progressing with a number of EU sites to ensure that the two leading products are fully tested for validation by the end of the year,” she added. 

The Company, which works as an innovator in kidney donor transplant diagnostics, has now partnered with 3 US medical universities to ‘validate’ its 2 cutting edge tests (Clarava & Tuteva) with confirmatory results expected by the end of 2021.

Today, it seems the best treatment for kidney failure is having a transplant, which requires a donor match, surgery and a lifetime of immuno-suppressants in order to prevent rejection. The outlook for this pathway is more optimistic, with 5-year survival rates doubling to > 80%. Albeit organs are in scarce supply (21,000 pa) with 100,000 people on US waiting lists.

Shares in Verici Dx have nearly doubled in value since the company's admission to AIM in November 2020 and increased by nearly 30% since the beginning of the year alone. This announcement provides investors with additional reasons to be positive on the stock as positive Newsflow emerges on the validation of its proprietary technology with confirmatory results expected by the end of 2021.

VRCI price chart

Reason to Follow 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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The information, investment views and recommendations in this article are provided for general information purposes only. Nothing in this article should be construed as a solicitation to buy or sell any financial product relating to any companies under discussion or to engage in or refrain from doing so or engaging in any other transaction. Any opinions or comments are made to the best of the knowledge and belief of the writer but no responsibility is accepted for actions based on such opinions or comments. Vox Markets may receive payment from companies mentioned for enhanced profiling or publication presence. The writer may or may not hold investments in the companies under discussion.

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