Calluna Pharma Successfully Completes Phase 1 Study of CAL101 for Fibrotic Conditions

OSLO, Norway I October 23, 2024 I Calluna Pharma AS (Calluna), a clinical-stage biotechnology company specializing in pioneering antibodies for the treatment of inflammatory and fibrotic diseases, has announced the successful completion of a Phase 1 clinical trial for CAL101, their leading product candidate. The study highlighted a positive safety profile, pharmacokinetics (PK), and immunogenicity for the monoclonal antibody (mAb).

CAL101 is a groundbreaking monoclonal antibody that targets S100A4, a damage-associated molecular pattern (DAMP) protein involved in serious diseases such as idiopathic pulmonary fibrosis and systemic sclerosis. Preclinical research has shown that CAL101 can prevent and treat fibrosis and alter the disease-specific activation of fibroblasts, which are the principal cells driving fibrosis progression.

Dr. Jonas Hallén, Co-Founder and Chief Medical Officer of Calluna Pharma, stated, "We are encouraged by the findings from the Phase 1 study. These results are a significant step forward in developing our lead asset, CAL101, especially for fibrotic and fibro-inflammatory diseases where new therapeutic options are urgently needed. We are enthusiastic as we now transition into the next phase of clinical development."

The first-in-human, randomized, double-blind, placebo-controlled Phase 1 study involved 57 participants and aimed to evaluate safety, tolerability, immunogenicity, and pharmacokinetics. The study was conducted under the leadership of Professor Dave Singh at the Medicines Evaluation Unit in Manchester, UK. The trial assessed single ascending doses of CAL101 in healthy volunteers and multiple ascending doses in patients with mild to moderate chronic plaque psoriasis.

Key results from the CAL101 Phase 1 study include:

1. **Safety**: The study demonstrated a favorable safety profile for CAL101.
2. **Pharmacokinetics**: The pharmacokinetic profile was positive, indicating how the body absorbs, distributes, metabolizes, and excretes the drug.
3. **Immunogenicity**: The immunogenicity profile, which measures the immune response to the drug, was also favorable.
4. **Tolerability**: CAL101 was well tolerated among both healthy volunteers and patients with chronic plaque psoriasis.

Calluna Pharma plans to advance CAL101 into Phase 2 studies in early 2025 to further investigate its efficacy in treating fibrotic and fibro-inflammatory conditions. The company remains committed to developing innovative treatments for diseases with significant unmet medical needs.

This promising progress marks a notable achievement in Calluna Pharma's mission to bring new therapeutic options to patients suffering from inflammatory and fibrotic diseases. The successful completion of the Phase 1 clinical trial for CAL101 paves the way for further development and potentially transformative treatments for conditions that currently lack effective interventions.