Aqualung Therapeutics Receives FDA Clearance for Phase 2a Lung Fibrosis Study

JUNO BEACH, Fla., Dec. 22, 2025 /PRNewswire/ -- Aqualung Therapeutics, a clinical-stage immunotherapeutics company, announced today that the Food and Drug Administration (FDA) has cleared its 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).

Upon the next round of funding, the company will initiate the multicenter 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.

PPF is a life-threatening condition that affects patients with underlying lung diseases that are either idiopathic or associated with autoimmune disorders. ALT-100mAb is a humanized murine mAb (monoclonal antibody) designed by Aqualung Therapeutics to neutralize the protein eNAMPT (extracellular nicotinamide phosphoribosyl transferase). This protein was first identified as a novel therapeutic target by Aqualung Therapeutics CEO & Founder Joe, GN Garcia MD.  eNAMPT is a master regulator of the immune system and contributes to excessive inflammation and scarring (fibrosis) of critical organs. By neutralizing eNAMPT, the ALT-100 mAb effectively halts this immune response.

"The Aqualung team is delighted that the FDA cleared our PAISANO study design," says Stan Miele, President and Chief Business Officer (CBO) of Aqualung Therapeutics. "With limited therapeutic treatment options for these patients, there is a significant clinical and medical need for novel therapies."

Joe GN Garcia, MD, Chief Executive Officer and Founder of Aqualung Therapeutics, notes that the approval follows a successful Phase 1a study in 32 healthy, adult volunteers; a P2a study in 15 patients with moderate to severe ARDS; along with extensive small and large animal toxicology studies, and more than 20 peer-reviewed publications validating the preclinical utility of ALT-100 mAb. "Our dramatic disease-attenuating effects of the ALT-100 mAb in preclinical models of lung fibrosis combined with the preliminary evidence of ALT-100 mAb's ability to dampen innate immunity activation and disease severity in the PUERTA ARDS trial gives us great confidence that this therapeutic drug will help address the unmet needs of patients with PPF," he states.

About Aqualung Therapeutics Corporation

Aqualung Therapeutics is an early-stage biotech company featuring an immunotherapeutics platform targeting eNAMPT. Its Next Gen platform, eNamptor™, includes the ALT-100 mAb, a plasma-based biomarker panel to predict disease risk and severity, and a genotyping assay to identify genetic risk of disease development, severity and mortality. This IND enables Aqualung to continue its progress with conducting human clinical trials that address the unmet therapeutic needs of patients with serious inflammatory, fibrotic diseases and cancers.

For more information on Aqualung's therapeutic trials with ALT-100 mAb. visit www.aqualungtherapeutics.com.

Media Contacts

Joe GN Garcia, MD, CEO and Founder | +1-312-618-7337 | [email protected]

Stan Miele, President & CBO | +1-919-410-0504 | [email protected]

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SOURCE Aqualung Therapeutics