Calluna Pharma completes successful phase 1 trial of new fibrotic disease drug

CAL101 shows promising results and is set to enter phase 2 development

Calluna Pharma AS has announced the successful completion of Phase 1 clinical trials for its lead drug candidate, CAL101, a first-in-class monoclonal antibody (mAb) targeting fibrotic and fibro-inflammatory diseases.

The study, conducted at the Medicines Evaluation Unit in Manchester, showed CAL101 to have a favorable safety, pharmacokinetic (PK) and immunogenicity profile. This trial included 57 subjects in a randomized, double-blind, placebo-controlled format, testing both single and multiple ascending doses.

Co-Founder and Chief Medical Officer Dr Jonas Hallén expressed optimism about the results, saying, “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.”

CAL101 targets the S100A4 protein, which is involved in serious diseases such as idiopathic pulmonary fibrosis and systemic sclerosis. Preclinical studies have shown that CAL101 can prevent and treat fibrosis and alter the disease-specific activation of fibroblasts, the key cells driving fibrosis progression.

The Phase 1 study’s key results include a favorable safety profile with no serious adverse events. Adverse events were mild to moderate and balanced between CAL101 and placebo groups. CAL101 demonstrated a favorable PK profile with dose-dependent exposure increases, supporting monthly dosing. In participants with anti-drug antibodies, titers were very low with no impact on PK and safety. Additionally, target engagement data supports complete target coverage at clinically relevant doses.

With these promising results, Calluna Pharma plans to advance CAL101 into Phase 2 trials in early 2025, focusing on fibrotic and fibro-inflammatory indications. The progression of this drug could mark a significant step forward in the treatment of these challenging diseases.