Clinical-stage immunotherapeutics company Aqualung Therapeutics announced on Monday that it has received approval from the US Food and Drug Administration (FDA) for a Phase 2a study of ALT-100 mAb as an anti-inflammatory and anti-fibrotic therapy in human subjects with Progressive Pulmonary Fibrosis (PPF).

This marks the company's second FDA-approved Investigational New Drug application (IND), following its 2022 clearance for acute respiratory distress syndrome (ARDS).

With the next round of funding, Aqualung Therapeutics will initiate the multicentre PAISANO trial (Preventing the Advance of Lung Fibrosis via the ALT-100 Antibody) to investigate the safety, pharmacokinetics, pharmacodynamic, and efficacy of ALT-100 mAb. The FDA waived the requirement for a prior idiopathic pulmonary fibrosis study due to compelling preclinical evidence and clinical safety evidence.

Welcoming the clearance of the PAISANO study design, Stan Miele, Aqualung Therapeutics' president and chief business officer, said: "With limited therapeutic treatment options for these patients, there is a significant clinical and medical need for novel therapies."