Calluna Pharma has announced the completion of its Phase I clinical study of CAL101, a first-in-class monoclonal antibody (mAb) targeting the S100A4 protein. The study assessed the safety, tolerability, immunogenicity, and pharmacokinetics (PK) of CAL101 in both healthy volunteers and patients with mild to moderate chronic plaque psoriasis, marking a significant step forward in developing treatments for fibrotic and fibro-inflammatory conditions.
The Phase I trial, conducted at the Medicines Evaluation Unit in Manchester, UK, was a double-blind, randomized, placebo-controlled study involving 57 participants. The trial design included single-ascending doses of CAL101 in healthy participants and multiple-ascending doses in psoriasis patients. The primary objective was to evaluate the safety and tolerability of CAL101 across a range of doses.
Key Findings from the Phase I Study
The results from the Phase I study indicate that CAL101 was well-tolerated, with no serious adverse events reported across all tested doses. Adverse events were generally mild to moderate and balanced between the CAL101 and placebo groups. Furthermore, the study revealed a favorable PK profile for CAL101, with dose-dependent increases in exposure that support the potential for once-monthly dosing. In participants who developed anti-drug antibodies, titres were very low and did not impact the PK and safety of CAL101.
Targeting S100A4 in Fibrotic Diseases
CAL101 is designed to target the S100A4 protein, which is implicated in the pathogenesis of idiopathic pulmonary fibrosis and systemic sclerosis. By inhibiting S100A4, CAL101 aims to address the underlying mechanisms driving fibrosis and inflammation in these conditions.
Future Development Plans
Calluna Pharma plans to progress CAL101 into Phase II studies for fibrotic and fibro-inflammatory indications by early next year. "We are encouraged by the findings from the Phase I study," said 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."
Calluna Pharma's Recent Merger and Funding
Calluna Pharma was formed in January of this year through the merger of Oxitope Pharma and Arxx Therapeutics, accompanied by a Series A funding round of €75 million. This funding is intended to advance the company's monoclonal antibody pipeline, including CAL101.
