Potential pulmonary fibrosis therapy CAL101 fares well in study
Phase 2 studies of fibrotic, fibro-inflammatory conditions are planned
CAL101, an investigational therapy with the potential to treat pulmonary fibrosis, showed a favorable safety and pharmacological profile in a Phase 1 clinical trial, according to results announced by Calluna Pharma, its developer.
“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,” Jonas Hallén MD, PhD, co-founder and chief medical officer of Calluna, said in a company press release.
Fibrosis, or scarring, plays a major role in many diseases and is often accompanied by inflammation. Pulmonary fibrosis refers to scarring in the lungs, which damages lung tissue, making it harder for patients to breathe.
How CAL101 deals with inflammation
CAL101 is an antibody-based therapy that’s designed to target S100A4, a so-called damage-associated molecular pattern (DAMP) protein. When cells are damaged, they release DAMPs like S100A4 to signal the immune system that something is wrong. Immune cells sensing DAMPs will ramp up inflammation to deal with any potential threat.
The system works effectively when cells are being attacked by viruses or bacteria that can be combated with inflammation. But in fibro-inflammatory diseases like pulmonary fibrosis, inflammatory tissue damage leads to the release of DAMPs, triggering more inflammation and leading to more tissue damage in a vicious cycle that drives disease progression. By blocking the activity of S100A4, CAL101 seeks to break this cycle and reduce tissue damage.
In a first-in-human Phase 1 clinical trial to test CAL101 in 57 participants, healthy volunteers were given single ascending doses of the therapy, while people with chronic plaque psoriasis, a chronic inflammatory skin disorder, were given multiple ascending doses.
The study’s main goal was to evaluate CAL101’s safety and pharmacological properties, and the results were positive overall: no serious side effects were reported and pharmacological data supported once-monthly dosing. Data also indicated that CAL101 blocks S100A4 as designed at the doses tested, according to Calluna.
Phase 2 studies to test CAL101 in fibrotic and fibro-inflammatory conditions are planned for early next year.
“We are encouraged by the findings from the Phase 1 study,” Hallén said. “We are excited as we now move into the next phase of clinical development.”
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