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.
- 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
- Press release. 08 May 2023: https://sarsia.com/news/arxx-therapeutics-initiates-first-in-human-trial
