Vicore's pulmonary fibrosis drug boosts lung function in phase 2

Vicore Pharma has recently achieved a significant milestone in its pursuit of a treatment for idiopathic pulmonary fibrosis (IPF), a chronic and often fatal lung disease. The Swedish biotech company has released promising final phase 2a clinical trial results for its flagship drug, buloxibutid. This angiotensin II type 2 receptor agonist has demonstrated considerable improvements in lung function among patients. Specifically, after 36 weeks of treatment, patients exhibited an average increase of 216 milliliters in their forced vital capacity (FVC), a key measure of lung function that assesses the volume of air a person can forcibly exhale. This improvement in FVC was nearly 400 milliliters higher than that observed in untreated patients, thereby meeting the primary endpoint of the trial.

Moreover, buloxibutid was found to be safe and well-tolerated. Vicore Pharma reported no drug-related serious adverse events and confirmed good gastrointestinal tolerability. The company presented these findings at the American Thoracic Society International Conference, highlighting the administration protocol of a 100-milligram dose taken orally twice daily.

The trial's design included evaluations at both the 12-week and 24-week marks to determine if patients needed to switch to standard-of-care treatment. Remarkably, 97% of patients continued with buloxibutid, showing positive outcomes at both checkpoints. This high retention rate underscores the drug's efficacy and tolerability.

Supporting these clinical results were measurements of two critical biomarkers. Researchers observed a reduction in plasma levels of TGFβ1, a cytokine known to contribute to IPF, and an increase in levels of collagenase MMP-13, an enzyme that can degrade fibrosis. These biomarker changes further substantiate the drug's potential therapeutic impact on the disease.

Vicore Pharma's CEO, Ahmed Mousa, expressed his enthusiasm over the trial results, stating, “Taking together the biomarker data and the compelling improvement in FVC over 36 weeks, we believe that buloxibutid has disease-modifying potential.” He described the outcomes as “exceeding our expectations.”

In January, Vicore made a strategic decision to focus all its resources on buloxibutid by discontinuing its preclinical program for immune-mediated inflammatory diseases. This move appears to be paying off, especially given the subsequent $10 million upfront payment from Nippon Shinyaku for the Japanese rights to the drug in February. The company is now preparing to advance buloxibutid into a phase 2b trial, which will assess changes in forced vital capacity over a 52-week period.

In addition to its work on buloxibutid, Vicore Pharma is also developing a digital therapeutic named AlmeeTM, which is based on cognitive-behavioral therapy. This digital tool is designed to treat anxiety in patients with pulmonary fibrosis, showcasing Vicore's commitment to addressing the multifaceted challenges of this debilitating disease.

The successful phase 2a trial results mark a significant step forward for Vicore Pharma in its mission to provide effective treatments for IPF. With the upcoming phase 2b trial and ongoing development of complementary therapies like AlmeeTM, the company aims to bring new hope to patients suffering from this challenging condition.