Evgen Pharma has signed a memorandum of understanding (MoU) with the University of Rochester School of Medicine & Dentistry to advance SFX-01 towards a clinical study for treating patients with chronic kidney disease (CKD).
The CKD disorder is caused by kidney dysfunction and is also known as chronic kidney failure.
Go deeper with GlobalData
Evgen’s SFX-01 product is a patented composition of synthetic sulforaphane and alpha-cyclodextrin.
Under the agreement, Evgen will supply SFX-01 to support a potential future clinical trial led by University of Rochester Nephrology division chief Thu Le.
According to the company, the intention of the study is to investigate SFX-01 in a randomised controlled trial to see if the treatment can decrease kidney disease progression rate.
The trial will also investigate whether SFX-01 can decrease markers of oxidative stress and inflammation in CKD patients.
Thu Le said: “We are pleased that Evgen will support our plans to undertake a clinical trial on SFX-01 in patients with CKD.
“Increased oxidative stress is a major molecular underpinning of CKD progression and our research suggests that patients with the GSTM1 null allele may particularly benefit from sulforaphane treatment via SFX-01 dosing.’”
Evgen noted that the study will test whether patients with the null allele of the Glutathione S-Transferase M1 (GSTM1) gene respond better compared to that of placebo-administered patients.
The GSTM 1 gene is part of the glutathione-S-transferase (GST) family regulated by Nrf2, which SFX-01 is said to activate.
Evgen Pharma CEO Stephen Franklin said: “We are delighted to be supporting the work of such a respected team and prestigious university.
“We very much hope the proposed trial will generate data demonstrating that SFX-01 could potentially improve the lives of patients suffering from CKD.”
In March last year, Evgen Pharma announced positive headline results from the open-label Phase II STEM trial of SFX-01 to treat patients with estrogen-positive (ER+) metastatic breast cancer.
