Remedy Cell, a clinical-stage biopharmaceutical company developing proprietary cell-derived therapies for fibrotic diseases, has initiated a partially blinded, randomised Phase 1b clinical trial to evaluate RC-0315 in patients with Idiopathic Pulmonary Fibrosis (IPF).

The first-in-human study is designed as a single- and repeat-dose, four-cohort trial assessing the safety and tolerability of RC-0315 compared with placebo. The investigational therapy is administered intra-bronchially to patients diagnosed with IPF.

In addition to its primary safety and tolerability objectives, the Phase 1b study includes exploratory endpoints to assess RC-0315’s impact on disease pathology. These assessments will be conducted using advanced imaging techniques and biomarker analyses from Bronchoalveolar lavage (BAL) fluid and plasma samples.

Commenting on the milestone, Ayelet Dilion Mashiah, Chief Executive Officer, Remedy Cell, said, “Advancing the company’s platform into clinical development marks a significant step forward for both Remedy Cell and patients living with IPF. The company believes its regenerative, multi-target approach has the potential to address the complexity of the disease and support meaningful recovery of lung function.”

IPF is a progressive and fatal interstitial lung disease affecting approximately three million people worldwide. The condition is marked by excessive collagen accumulation that causes lung tissue to become stiff and thickened, leading to irreversible loss of lung function. With a median survival of just two to five years following diagnosis, patients face worsening respiratory failure and a significant decline in quality of life. Current treatment options offer limited clinical benefit, underscoring the urgent need for new therapeutic approaches.

RC-0315 is a novel, multifactorial, multi-protein cell-derived therapy designed to simultaneously target multiple biological pathways involved in IPF. By addressing the complex mechanisms driving fibrosis, the therapy aims to reduce fibrotic burden, promote tissue repair and restore pulmonary function.