RedHill Biopharma (NASDAQ:RDHL) Ltd. has announced the results of a new preclinical study with its oral pill drug candidate opaganib (ABC294640), demonstrating its efficacy in significantly decreasing renal fibrosis in a unilateral ureteral obstruction-induced renal interstitial fibrosis model.
The company noted reports suggest that over 20% of hospitalized coronavirus (COVID-19) patients experience acute renal failure. Kidney fibrosis generally leads to loss of tissue function and subsequent organ failure, with a high mortality rate.
The company further noted that its global 475-patient Phase 2/3 clinical trial with opaganib in hospitalized COVID19 patients has completed treatment and follow up phase, with top-line results upcoming New therapeutic small molecules to modulate fibrosis are urgently needed. The aim of the in vivo efficacy study was to verify the effect of opaganib on kidney inflammation and fibrosis in a unilateral ureteral obstruction (UUO) model – a well-characterized model for renal fibrosis. Results from the study showed that opaganib significantly decreased renal fibrosis.
READ: RedHill Biopharma demonstrates strong inhibition by opaganib of the coronavirus (COVID-19) Delta variant
In a statement, Dr Reza Fathi, RedHill's senior VP, R&D commented: "A final, common pathway in chronic kidney disease is fibrosis, the formation of internal scar tissue, which can cause devastating effects and can ultimately lead to end-stage kidney failure. "This new preclinical data, demonstrating opaganib's ability to decrease kidney fibrosis, along with its observed anti-inflammatory properties, positions opaganib as a potential novel therapy for the millions of patients suffering from chronic kidney disease and potentially extends to COVID-19 patients with Acute Kidney Injury (AKI) who are at risk of developing renal fibrosis."
He added: "Kidney injury and its associated progression to fibrosis is an important facet in both the acute phase of COVID-19 and in long COVID. Recent research has shown that after acute kidney injury, which we know can be a result of COVID-19 infection, the kidneys often fail to repair themselves properly and that sphingosine kinase-2 (SK2), which is inhibited by opaganib, is part of this process.
"These findings provide further support for the extensive work we are doing with opaganib in COVID-19. With the upcoming readout, we expect to learn more about kidney outcomes from hospitalized COVID-19 patients treated with opaganib in our global Phase 2/3 study."
Renal fibrosis, a common outcome of chronic kidney disease (CKD), is characterized by an excessive accumulation and deposition of extracellular matrix (ECM) components and fibrous tissue. Renal fibrosis may ultimately lead to end-stage renal failure, a devastating disorder that requires dialysis or kidney transplantation. CKD is a very common disease, affecting 15% of US adults.
Opaganib, a leading novel small molecule investigational oral pill in development for the treatment of COVID-19, is a unique dual antiviral and anti-inflammatory drug that acts on the cause and effect of COVID-19. Opaganib is host-targeted and is expected to be effective against emerging viral variants, having already demonstrated strong inhibition against variants of concern, including Delta.
It is believed to exert its antiviral effect by selectively inhibiting SK2, a key enzyme produced in human cells that may be recruited by the virus to support its replication. Opaganib's global 475-patient Phase 2/3 study in hospitalized patients with COVID-19 has completed its treatment and follow-up phase, and study top-line results are upcoming.
RedHill Biopharma (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases.
Contact the author at jon.hopkins@proactiveinvestors.com
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