CAL101 is a monoclonal antibody targeting the S100A4 protein for the treatment of fibrotic and fibro-inflammatory diseases. Credit: JOURNEY STUDIO7 / Shutterstock.

Calluna Pharma has concluded the Phase I clinical study of its lead product, CAL101, for fibrotic and fibro-inflammatory indications.

CAL101 is a first-in-class monoclonal antibody (mAb) targeting the S100A4 protein concerned with idiopathic pulmonary fibrosis and systemic sclerosis.

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The study, led by Professor Dave Singh at the Medicines Evaluation Unit in Manchester, UK, aimed to assess the tolerability, safety, immunogenicity, and pharmacokinetics (PK) of CAL101.

This Phase I, first-in-human, double-blind, randomised, placebo-controlled study involved 57 subjects, including healthy volunteers and patients with mild to moderate chronic plaque psoriasis.

It tested single-ascending doses of CAL101 in healthy participants and multiple-ascending doses in psoriasis patients.

Results indicated that the antibody was well tolerated, and no serious adverse events were reported across all tested doses.

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Adverse events were mild to moderate and were found to be balanced between the CAL101 and placebo groups.

The study also revealed a favourable PK profile for CAL101, with dose-dependent increases in exposure that support the potential for once-monthly dosing.

Calluna Pharma co-founder and chief medical officer Jonas Hallén commented: “We are encouraged by the findings from the Phase I 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.”

Furthermore, titres were observed to be very low in participants who developed anti-drug antibodies and did not impact the PK and safety of CAL101.

Looking ahead, Calluna plans to progress CAL101 into Phase II studies for fibrotic and fibro-inflammatory indications by early next year.

In January this year, Oxitope Pharma and Arxx Therapeutics merged to form Calluna Pharma, raising €75m in a Series A funding round.