Calluna Pharma Successfully Completes Phase 1 Clinical Study of CAL101, a First-in-Class Therapeutic for Fibrotic and Fibro-Inflammatory Indications

• CAL101 is an anti-S100A4 monoclonal antibody (mAb) and Calluna’s lead drug candidate
• Study demonstrated a favorable safety, pharmacokinetic (PK) and immunogenicity profile
• CAL101 is now entering Phase 2 clinical development

OSLO, Norway–(BUSINESS WIRE)–Calluna Pharma AS (Calluna), a clinical stage biotechnology company pioneering first-in-class antibodies to treat inflammatory and fibrotic diseases, today announced the completion of Phase 1 clinical study for CAL101, Calluna’s lead product candidate. The study demonstrated a favorable safety, pharmacokinetic (PK) and immunogenicity profile for the mAb.

CAL101 is a first-in-class mAb that targets S100A4, a damage-associated molecular pattern (DAMP) protein implicated in serious and life-threatening diseases, such as idiopathic pulmonary fibrosis and systemic sclerosis. Preclinical studies have demonstrated the ability of CAL101 to prevent and treat fibrosis and modify the disease-specific activation of fibroblasts – the key effector cells driving progression of fibrosis¹.

Jonas Hallén M.D., Ph.D., Co-Founder and Chief Medical Officer of Calluna Pharma, commented: “We are encouraged by the findings from the Phase 1 study. These results are an important step forward in the development of our lead asset, CAL101, particularly for fibrotic and fibro-inflammatory diseases where there remains a critical need for innovative therapeutic options. We are excited as we now move into the next phase of clinical development.”

The first-in-human, randomized, double-blind, placebo-controlled Phase 1 study in 57 subjects was designed to evaluate safety, tolerability, immunogenicity and PK, and was led by Professor Dave Singh at the Medicines Evaluation Unit in Manchester, UK². The study tested single ascending doses of CAL101 in healthy volunteers and multiple ascending doses in patients with mild to moderate chronic plaque psoriasis.

Summary of key CAL101 Phase 1 study results:

• CAL101 demonstrated a favorable safety profile and was well tolerated with no Serious Adverse Events across all doses tested.
• Adverse Events were all mild to moderate and balanced between CAL101 and placebo.
• CAL101 demonstrated a favorable PK profile with dose-dependent increases in exposure, supporting once monthly dosing.
• In participants with anti-drug antibodies, titers were very low and with no impact on PK and safety.
• Target engagement data supports complete target coverage at clinically relevant doses.

In early 2025, Calluna plans to advance CAL101 into Phase 2 studies in fibrotic and fibro-inflammatory indications.

1. Denton et al. 2023: https://doi.org/10.1136/ard-2023-223862; Thuong Trinh-Minh et al, 2023: https://acrjournals.onlinelibrary.wiley.com/doi/10.1002/art.42781
2. Press release. 08 May 2023: https://sarsia.com/news/arxx-therapeutics-initiates-first-in-human-trial

For more information about Calluna Pharma, please visit: www.callunapharma.com

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