Cantargia's CAN10 Demonstrates Promising Biomarker Results and Safety in Phase 1 Trial
核心洞察
Cantargia (搜索)'s CAN10 phase 1 trial shows good safety and promising biomarker results in healthy participants receiving a single dose.
CAN10 completely blocked IL-1 (搜索) signaling in the blood of participants one week after infusion, validating its unique mechanism of action.
The ongoing multiple dosing part of the trial will generate additional data ahead of phase 2 trials planned to start in H2 2025.
Cantargia (搜索) AB announced positive results from its CAN10 phase 1 clinical study, revealing good safety and promising biomarker results in healthy participants. The single-dose study demonstrated that CAN10 effectively blocks IL-1 (搜索) signaling in the blood of participants even one week after infusion, reinforcing its potential as a treatment for autoimmune and inflammatory diseases.
The phase 1 trial included nine groups with 68 participants receiving a single dose of CAN10 or a placebo. The primary endpoint of the trial focused on safety, with secondary endpoints evaluating the drug's impact on key biomarkers. The study's findings strongly validate the unique mode of action of CAN10, which targets IL1RAP (搜索) and inhibits signaling via IL-1 (搜索), IL-33 (搜索) and IL-36 (搜索).
Biomarker Results
Biomarker samples taken during the study showed a potent, dose-dependent blockade of IL1RAP (搜索) function, measured as inhibition of IL-36 (搜索) signaling in immune cells. Finalized analyses also confirmed that CAN10 completely blocks IL-1 (搜索) signaling in immune cells a week after a single dose. This dual blockade of both IL-1 and IL-36 signaling is a unique feature of IL1RAP-blockade, distinguishing it from drugs targeting individual pathways.
Ongoing Multiple Dosing Study
The second part of the phase 1 trial, which investigates multiple dosing of CAN10 in participants with psoriasis (搜索), is currently ongoing. Additional results from this portion of the trial are expected to provide further insights into the drug's efficacy and safety profile. Cantargia (搜索) plans to initiate phase 2 clinical trials in the second half of 2025, focusing on indications such as hidradenitis suppurativa (搜索) or systemic sclerosis (搜索).
CAN10's Potential
CAN10 is an antibody designed to treat autoimmune and inflammatory diseases stimulated by IL-1 (搜索), IL-33 (搜索), and/or IL-36 (搜索). Preclinical studies in models of systemic sclerosis (搜索), psoriasis (搜索), myocarditis, and other inflammatory conditions have shown that a CAN10 surrogate antibody significantly reduced disease development. The ongoing phase 1 trial is investigating increasing levels of CAN10 via single intravenous administration in healthy subjects, followed by studies of subcutaneous multiple dosing in participants with psoriasis. Up to 80 subjects may be included in the trial.
"We are extremely happy with the outcome of the single dose part of the phase 1 clinical trial. CAN10 show good safety and potent effects on biomarkers. Additional results of high importance will be generated in the ongoing multiple dosing part ahead of phase 2 clinical trials, planned to start H2 2025," said Göran Forsberg, CEO of Cantargia (搜索).