Calluna Pharma AS has announced positive results from its Phase 1 clinical trial of CAL101, a first-in-class monoclonal antibody (mAb) targeting fibrotic and fibro-inflammatory diseases. The trial demonstrated a favorable safety, pharmacokinetic (PK), and immunogenicity profile, paving the way for Phase 2 development in early 2025.
The Phase 1 study, conducted at the Medicines Evaluation Unit in Manchester, employed a randomized, double-blind, placebo-controlled design. It included 57 healthy volunteers who received either single or multiple ascending doses of CAL101. The primary objective was to assess the safety and tolerability of the drug.
"We are encouraged by the findings from the Phase 1 study," said Dr. Jonas Hallén, Co-Founder and Chief Medical Officer of Calluna Pharma. "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."
Targeting S100A4 in Fibrotic Diseases
CAL101 is designed to target the S100A4 protein, a key mediator in the pathogenesis of various fibrotic diseases, including idiopathic pulmonary fibrosis (IPF) and systemic sclerosis. S100A4 is involved in the activation of fibroblasts, the cells responsible for the excessive deposition of extracellular matrix that characterizes fibrosis. Preclinical studies have indicated that CAL101 can effectively prevent and treat fibrosis by modulating fibroblast activity.
Key Findings from the Phase 1 Trial
The Phase 1 trial revealed several important findings. CAL101 exhibited a favorable safety profile, with no serious adverse events reported. Adverse events were generally mild to moderate and were balanced between the CAL101 and placebo groups. The drug also demonstrated a favorable PK profile, with dose-dependent exposure increases, supporting the feasibility of monthly dosing. Furthermore, in participants who developed anti-drug antibodies, titers were very low and did not appear to impact PK or safety. Target engagement data indicated complete target coverage at clinically relevant doses.
Next Steps: Phase 2 Trials
Based on these promising results, Calluna Pharma intends to initiate Phase 2 trials of CAL101 in early 2025. These trials will focus on evaluating the efficacy of CAL101 in specific fibrotic and fibro-inflammatory indications. The advancement of CAL101 represents a potentially significant advancement in the treatment of these challenging diseases, addressing a critical unmet medical need.
