Early trial data on IgA nephropathy treatment expected by year’s end
Drug designed to have 'enhanced potency,' last longer in the body
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Initial data from a mid-stage clinical trial testing vensobafusp alfa for IgA nephropathy are expected before the end of the year. (Image from iStock)
Enrollment of people with immunoglobulin A nephropathy (IgAN) in a mid-stage clinical trial testing Jasper Therapeutics’ treatment candidate vensobafusp alfa (KP104) — designed to last longer in the body — is now complete, with interim results expected by year’s end.
A so-called basket trial, the Phase 2 study (NCT05517980) is evaluating the safety, pharmacological properties, and early effectiveness of vensobafusp alfa in people with IgAN and other kidney diseases, namely complement 3 glomerulopathy (C3G) and focal segmental glomerulosclerosis (FSGS). Basket trials are those designed to test a therapy in different patient groups.
The proof-of-concept study, involving adults with IgAN and being run in China, was launched by the therapy’s original developer, Kira Pharmaceuticals, which was acquired by Jasper earlier this year.
“Completing enrollment of the first IgAN [patient group] on schedule reflects both the high unmet need in this disease and strong execution by our clinical teams at Jasper and Kira,” Greg Keenan, MD, chief medical officer of Jasper, said in a company press release announcing the milestone and providing other updates.
“We look forward to reporting initial data from the IgAN [group] by the end of this year,” Keenan said.
A chronic condition, IgAN is driven by the buildup of a specific kind of antibody, called IgA, in the kidneys. This can activate the complement system, a group of circulating immune proteins that are normally inactive until a chain reaction activates them one after another to trigger inflammation. Complement activation is thought to be a key driver of kidney damage in IgAN.
Trial testing effectiveness of vensobafusp alfa in adults
Vensobafusp alfa is designed to simultaneously suppress two proteins in the complement system: Factor H and C5. Factor H is a key part of the alternative complement pathway, which is the main molecular trigger that sets off complement activation in IgAN. C5, meanwhile, is an executor of the terminal complement pathway, which actually promotes inflammation and tissue damage.
By blocking both of these complement proteins, the experimental therapy aims to dampen complement activation and ultimately limit tissue damage.
“Engineered to have [a longer duration in the body] and enhanced potency, vensobafusp alfa has a formulation suitable for both intravenous [into-the-vein] and subcutaneous [under-the-skin] administrations,” the release stated.
Jasper is developing the therapy for IgAN and other complement-mediated diseases.
“We believe vensobafusp alfa’s bifunctional ability to [block] both the alternative and terminal complement pathways may provide the potential for differentiated onset and efficacy in complement driven diseases,” Keenan said.
According to Jasper, the IgAN part of the Phase 2 trial has finished recruiting, with a total of 18 participants, all adults, now enrolled. Each is receiving under-the-skin injections of vensobafusp alfa, starting with an induction regimen, then followed by dosing every two, four, or eight weeks.
The main goals of the approximately one-year study are to evaluate the safety and tolerability of vensobafusp alfa in people with IgAN. The study will also explore the treatment’s effect on disease activity, with the aim of identifying the optimal dosing regimen for future trials.
