Sep 30, 2024 · Regulatory information

Cantargia reports start of multiple dosing part in CAN10 phase 1 clinical trial

Cantargia (Cantargia AB; Nasdaq Stockholm: CANTA) today reported that the first participant has started study treatment in the second part of the phase 1 clinical trial using CAN10, an antibody designed for treatment of autoimmune or inflammatory diseases. This part investigates multiple dosing during 6 weeks in participants with mild to moderate plaque psoriasis. Besides safety and pharmacokinetics, the trial is designed to analyze a number of biomarkers in both skin biopsies as well as blood.

“The CAN10 clinical program continues to advance nicely with the start of multiple dosing. As this part of the phase 1 trial evaluates participants with psoriasis, significant data will be generated which will be useful to investigate the CAN10 mechanism of action and disease biomarkers in patients ahead of larger phase 2 studies,” said Göran Forsberg, CEO of Cantargia.

CAN10 is one of two clinical projects in the Cantargia pipeline. The CAN10 antibody has been designed for treatment of several autoimmune/inflammatory diseases. The ongoing phase 1 clinical trial initially investigates increasing levels of CAN10 as single dose administration in healthy subjects followed by studies of multiple dosing using subcutaneous administration in participants with psoriasis. The primary endpoint relates to safety. Details on the trial can be found at https://clinicaltrials.gov/study/NCT06143371.

No safety concerns have been observed during the single dose studies to date and in accordance with the protocol, the first of two planned multiple dosing groups has now started. Each participant will receive treatment during six weeks and treatment in the two groups are planned to finish end of Q1 2025.

About Cantargia
Cantargia AB (publ), reg. no. 556791-6019, is a biotechnology company that develops antibody-based treatments for life-threatening diseases and has established a platform based on the protein IL1RAP, involved in a number of cancer forms and inflammatory diseases. Cantargia’s oncology program, the antibody nadunolimab (CAN04), is being studied clinically primarily in combination with chemotherapy with a focus on pancreatic cancer, non-small cell lung cancer and triple-negative breast cancer. Positive interim data for the combinations indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia’s second development program, the antibody CAN10, blocks signaling via IL1RAP in a different manner than nadunolimab and addresses treatment of serious autoimmune/inflammatory diseases, with initial focus on systemic sclerosis and myocarditis.

Cantargia is listed on Nasdaq Stockholm (ticker: CANTA). More information about Cantargia is available at www.cantargia.com.

About CAN10
The CAN10 antibody binds strongly to its target IL1RAP and has a unique capability to simultaneously inhibit signaling via IL-1, IL-33 and IL-36. Inhibition of these signals can be of significant value in the treatment of several inflammatory or autoimmune diseases. The initial focus of CAN10 will be on two severe diseases: hidradenitis suppurativa (HS) and systemic sclerosis. In preclinical in vivo models of inflammatory diseases, such as systemic sclerosis, psoriasis, psoriatic arthritis, atherosclerosis, myocarditis and peritonitis, a CAN10 surrogate antibody significantly reduced the development of the disease. A clinical phase 1 study, investigating CAN10 in healthy volunteers and psoriasis patients, is ongoing. Up to 80 subjects may be included in the trial. Good safety is shown at the completed dose levels, and additional data from the trial are expected continuously during 2024 and 2025.