Cantargia AB has announced promising pharmacokinetic (PK) data from the first multiple ascending dose (MAD) cohort in its Phase 1 clinical trial of CAN10, an antibody targeting IL1RAP for the treatment of inflammatory diseases. The data further supports the potential for subcutaneous dosing every four weeks, which could provide a significant competitive advantage in the treatment landscape for hidradenitis suppurativa (HS).
"These first MAD CAN10 clinical data underscore the potential for sc dosing every 4th week. This would be a competitive advantage in the market for HS treatments," said Damian Marron, Interim CEO of Cantargia. "The FDA feedback and SAB endorsement encourage us as we move towards our planned phase 2 study in HS towards the end of this year."
CAN10 Mechanism and Clinical Progress
CAN10 is designed to potently inhibit the activity of multiple pro-inflammatory cytokines—IL-1, IL-33, and IL-36—by targeting the IL1RAP protein. This multi-cytokine inhibition approach differentiates CAN10 from other treatments and could potentially address the complex inflammatory pathways involved in HS.
The ongoing Phase 1 trial has already completed ten single ascending dose (SAD) cohorts with intravenous administration in healthy participants. The trial has now progressed to multiple ascending dose cohorts with subcutaneous administration in both healthy participants and those with mild to moderate plaque psoriasis. The first MAD cohort with healthy subjects has completed dosing and will be followed by higher dose cohorts.
Pharmacokinetic results from the SAD cohorts demonstrated dose proportionality at clinically relevant levels. The observed exposures, combined with modeling results, initially suggested that 4-weekly dosing would be feasible. This has now been reinforced by the exposure profiles observed in the first MAD cohort. Additional evaluations and simulations will be conducted once complete PK data from this cohort becomes available.
FDA Feedback and Regulatory Path Forward
In a significant regulatory milestone, Cantargia has successfully completed a pre-IND meeting with the FDA regarding its planned Phase 2 study in HS. The FDA provided written responses indicating that the proposed study design was reasonable and clarified the primary endpoint, which aligns with expectations for regulatory approval.
The company reports that it will incorporate the FDA's additional comments into the final protocol. The Investigational New Drug (IND) submission remains on track for the second half of 2025, with the Phase 2 study expected to begin toward the end of the year.
Expert Endorsement for HS Indication
Cantargia also convened a Scientific Advisory Board (SAB) with hidradenitis suppurativa clinical experts from the United States and Europe. These key opinion leaders provided strong support for developing CAN10 for HS treatment, based on the underlying biology of the disease and Cantargia's preclinical mechanistic data.
Despite recent approvals and development of new treatments for HS, the experts emphasized that significant unmet medical needs remain, and additional treatment options are necessary. Their feedback on study population and endpoints aligned with the FDA's recommendations and will be implemented in the final study design.
Hidradenitis Suppurativa: A Significant Unmet Need
Hidradenitis suppurativa is a chronic, debilitating inflammatory skin condition characterized by painful nodules, abscesses, and scarring primarily affecting areas where skin rubs together, such as the armpits, groin, and under the breasts. The condition significantly impacts patients' quality of life and can lead to substantial physical and psychological distress.
While recent years have seen new treatment approvals for HS, including biologics targeting specific inflammatory pathways, many patients still experience inadequate disease control. CAN10's novel mechanism of action, targeting multiple inflammatory cytokines simultaneously, could potentially address treatment gaps for patients who don't respond adequately to existing therapies.
Development Timeline and Next Steps
The Phase 2 study in HS will aim to demonstrate clinical proof of concept and identify the optimal dose level and regimen for further development in patients with moderate to severe disease. With the IND submission planned for the second half of 2025 and positive regulatory feedback already secured, Cantargia appears well-positioned to advance CAN10 through clinical development.
The company continues to collect data from the ongoing Phase 1 trial, with additional results expected throughout 2025. These data will further inform the design and execution of the planned Phase 2 study in HS patients.
Broader Development Program
Beyond hidradenitis suppurativa, Cantargia is also exploring CAN10's potential in systemic sclerosis, another serious inflammatory condition with limited treatment options. Preclinical studies have shown promising results in models of various inflammatory diseases, including systemic sclerosis, psoriasis, psoriatic arthritis, atherosclerosis, myocarditis, and peritonitis.
The company's broader pipeline includes nadunolimab (CAN04), an antibody targeting IL1RAP for oncology indications, which is being studied in combination with chemotherapy for pancreatic cancer, non-small cell lung cancer, and triple-negative breast cancer.
