The first subject has been dosed in the randomised Phase II trial of Palleon’s E-602 (HLX79), a first-in-class human sialidase enzyme therapeutic, in conjunction with Henlius’ Hanlikang (rituximab biosimilar) for active glomerulonephritis treatment.
The trial is evaluating the safety and efficacy of the combination to treat this form of autoimmune kidney disease, which includes membranous nephropathy and lupus nephritis.
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It is a placebo-controlled, double-blind, multi-centre study and is being carried out in mainland China.
The collaboration between Palleon and Henlius, announced in December 2024, aims to advance glyco-immunology treatments for autoimmune diseases. This trial is a direct result of their ongoing partnership.
The primary objective is to assess the tolerability and safety of the combination compared to a placebo and HLX01 (Hanlikang).
Secondary objectives include evaluating the pharmacodynamics, immunogenicity, and pharmacokinetics of the combination therapy.
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By GlobalDataThe trial will also measure clinical efficacy and changes in biomarkers.
Participants will be administered varying doses of HLX79 at 10mg/kg, 20mg/kg, or 30mg/kg, or a placebo, each paired with HLX01.
Following the initial treatment phase, participants will enter a 20-week follow-up phase, after which they will be evaluated in a pre-second treatment phase.
Should the investigator decide that a second treatment phase is unnecessary for a participant, they will remain in the follow-up phase until they reach the full 48-week duration of the study.
Palleon Pharmaceuticals CEO and founder Jim Broderick said: “E-602’s unique dual mechanism enhances the depletion of autoreactive memory B-cells and reduces pro-fibrotic macrophages that cause organ damage.
“Preclinical and early clinical experiments of E-602, in combination with rituximab, suggest that targeting these two key drivers of autoimmune pathologies can reduce the severity of autoimmune flares and improve treatment response in active glomerulonephritis.”
Last year, Palleon reported the outcomes from its Phase I/II trial of E-602, along with cemiplimab (Libtayo), to treat patients with programmed death-ligand 1 (PD-(L)1)-resistant solid tumours.
