Cantargia, a Sweden-based biotechnology company, has commenced an expanded segment of its ongoing Phase I clinical trial for CAN10, a novel antibody. The first participant has been dosed in this expanded phase, which seeks to further evaluate the antibody's pharmacokinetic properties, safety profile, and biomarker effects in healthy subjects.
Targeting IL-1RAP to Modulate Inflammation
CAN10 is designed to inhibit the pro-inflammatory cytokines IL-1, IL-33, and IL-36 by targeting the interleukin-1 receptor accessory protein (IL-1RAP). This mechanism of action differentiates it from Cantargia's oncology program, which utilizes the antibody nadunolimab (CAN04). CAN10 aims to block signaling via IL1RAP to treat inflammatory and autoimmune conditions.
The Phase I trial's primary objective is to assess the safety of CAN10. Initial results from nine single-ascending dose (SAD) cohorts and one multiple-ascending dose (MAD) cohort, involving subjects with mild to moderate plaque psoriasis, have shown no safety concerns. Biomarker studies indicated that the antibody can completely inhibit IL-1 and IL-36 stimulation.
Potential for Extended Dosing Intervals
"The accrued CAN10 clinical results underscore the potential for dosing every fourth week," said Cantargia CEO Göran Forsberg, highlighting the therapy's long-lasting effects observed in the trial. This extended dosing interval could offer a significant advantage over existing treatments for chronic inflammatory conditions.
To further investigate this potential, the clinical protocol was amended to include up to two additional SAD cohorts and two additional MAD cohorts in healthy subjects. These activities are planned for the coming months, with the goal of commencing Phase II trials in the second half of 2025.
Focus on Hidradenitis Suppurativa and Systemic Sclerosis
The primary focus of CAN10's clinical development will be on treating hidradenitis suppurativa (HS) and systemic sclerosis, conditions characterized by significant unmet medical needs. These chronic inflammatory diseases often have limited treatment options and can severely impact patients' quality of life.
Preclinical in vivo models have demonstrated that a surrogate antibody of CAN10 decreased disease development in several inflammatory conditions, including psoriasis, systemic sclerosis, psoriatic arthritis, peritonitis, atherosclerosis, and myocarditis. These findings support the potential of CAN10 as a therapeutic intervention for a range of inflammatory disorders.
Cantargia completed the Good Laboratory Practice (GLP) toxicity study of CAN10 in January 2023, further supporting its safety profile. The company is also advancing its oncology program with nadunolimab (CAN04), which is undergoing clinical trials with chemotherapy combinations for various cancers.
