LUND, SE / ACCESS Newswire / May 12, 2025 / Cantargia (STO:CANTA)
Pharmacokinetic (PK) model generated based on the single ascending dose (SAD) data and the first multiple ascending dose (MAD) cohort.
Model confirms the predicted dosing regimen for phase 2, including subcutaneous (SC) dosing every 4-week.
Safety of multiple SC dosing at a clinically relevant dose confirmed.
Potent and long-lasting inhibitory effects on several key inflammatory biomarkers.
Cantargia (Cantargia AB (publ); Nasdaq Stockholm: CANTA) today announced the results of the first CAN10 PK model with SC multiple dose PK data. The model indicates a high bioavailability of CAN10 and confirms every 4-week dosing choice for phase 2 studies. In addition, CAN10 shows potent and long-lasting inhibitory effects on several key inflammatory biomarkers, further strengthening the potential benefit of CAN10 in inflammatory diseases such as hidradenitis suppurativa (HS) and atopic dermatitis (AD).
"These data from the ongoing phase 1 study of CAN10 confirm the very promising profile of CAN10 as a new treatment for inflammatory diseases", said Morten Lind Jensen, Chief Medical Officer of Cantargia. "The potential to block the entire IL-1 super family of inflammatory cytokines with one dose every four weeks gives CAN10 a strong competitive position, with the potential to reach new levels of efficacy in HS and other diseases".
CAN10 is an antibody against IL1RAP designed to potently inhibit the activity of the pro-inflammatory and disease promoting cytokines of the IL-1-super family: IL-1, IL-33 and IL-36. CAN10 is currently being evaluated in a phase 1 clinical trial. The first multiple SC dose cohort in healthy volunteers has now been completed and determined safe, consequently the last multiple dose cohort in healthy volunteers has been started. The cohort of subjects with psoriasis continues recruitment and data will be analyzed and announced at the appropriate time. These data are not required to be able to start phase 2 studies.
PK data from the completed single ascending dose (SAD) cohorts and the first multiple SC dose cohort has been used to generate the PK model to be able to determine dose and dosing regimen for future studies. The PK model confirms the predicted dose and dosing regimen for Ph2, including potential for SC dosing every 4-weeks. The data also demonstrate high bioavailability and a dose proportional PK profile. In addition, new biomarker results show long-lasting effects of CAN10 with complete inhibition of IL-36 and IL-1 beta stimulation 14 days after SC dosing of CAN10. The effects of CAN10 are broad, with inhibition of several key inflammatory biomarkers known to play disease promoting roles in inflammatory diseases such as HS and AD. With the promising new results, Cantargia continues to plan for the start of two phase 2 studies towards the end of 2025; the first will be a randomized, placebo-controlled, dose and regimen ranging study in HS and the second will be a small pilot study in AD patients not responding to dupilumab treatment.
For further information, please contact
Damian Marron, Interim CEO
Telephone: +46 (0)46-275 62 60
E-mail: damian.marron@cantargia.com
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 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 hidradenitis suppurativa and systemic sclerosis.
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 treatment resistant atopic dermatitis (AD). 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. Good safety is shown at the completed dose levels, and additional data are expected continuously during 2025.
Attachments
Cantargia announces successful Phase 1 results: PK/PD data of subcutaneously administered CAN10 confirms every 4-week dosing choice in Phase 2
SOURCE: Cantargia
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/cantargia-announces-successful-phase-1-results-pk%2fpd-data-of-subcutan-1026398
