Clinical study is researching patients with diabetes and advanced chronic kidney disease
Orbsen Therapeutics – a company which focuses on stromal cell immunotherapies – has announced positive results from the EU Horizon 2020-funded Nephstrom clinical trial for diabetic kidney disease (DKD).
The study is a double-blind, randomised, placebo-controlled phase 1/2a trial evaluating the tolerability, safety and preliminary efficacy of Orbcel. The treatment is an off-the-shelf allogeneic bone marrow-derived mesenchymal stromal cell immunotherapy and the study involves adult patients with type 2 diabetes and progressive DKD.
Orbcel is a proprietary formulation of highly purified immunomodulatory stromal cells and the research into its effectiveness was led by the Mario Negri Institute for Pharmacological Research IRCCS.
The interim results discovered that the safety and tolerability profile of Orbcel was found to be similar to placebo and no treatment-related adverse effects due to the stromal cell infusions were observed.
Meanwhile, a single infusion of intravenously delivered Orbcel was associated with statistically significant preservation of kidney function over baseline. Monitored blood markers also suggested that the treatment was associated with evidence of stabilisation in the proportion with regulatory T cells in blood.
Enrolment in the second dose level patient cohort was completed late last year and interim results are expected to be available in the second half of this year
Dr Stephen Elliman, chief scientific officer at Orbsen, reflected: “We’re very encouraged by the safety profile and the preliminary efficacy signal that we have seen with our allogeneic cell therapy in patients with diabetes and chronic kidney disease.”
“Our goal with Orbcel is to resolve systemic inflammation and improve kidney function, so that these patients will not require dialysis or a kidney transplant. The growing burden of DKD and its impact on healthcare make this an important disease target for Orbsen and our technology,” he added.
Professor Guiseppe Remuzzi, director of the Mario Negri Institute for Pharmacological Research IRCCS, concluded: “The current standard of care for DKD patients includes multiple types of drug therapy, such as renin-angiotensin-aldosterone system inhibitors and the more recently approved drug class known as sodium-glucose transporter 2 inhibitors, which have a proven ability to slow the decline of kidney function.”
DKD affects 30 to 40% of adults living with type 2 diabetes and accounts for about 40% of all patients with end-stage kidney disease. It also greatly increases the risk of heart and blood vessel disease.