Phase 2a Study Clinically Validates the eNAMPT Pathway and Demonstrates Favorable Safety Profile of ALT-100 in ARDS

Clinical validation of the eNAMPT pathway in humans strengthens ALT-100's potential as a first-in-class platform therapy across inflammatory and fibrotic diseases

TUCSON, AZ, UNITED STATES, July 9, 2026 /EINPresswire.com/ -- Aqualung Therapeutics, a clinical-stage biotechnology company developing first-in-class therapeutics targeting the eNAMPT pathway, today announced publication of positive results from its randomized, double-blind, placebo-controlled PUERTA Phase 2a clinical trial evaluating ALT-100 in patients with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS). Published in the American Journal of Respiratory and Critical Care Medicine, the study provides the first peer-reviewed clinical validation of the eNAMPT pathway in humans, representing an important milestone for both ALT-100 and Aqualung's broader inflammatory and fibrotic disease platform.

Compared with placebo-treated patients, ALT-100 demonstrated encouraging biologic and clinical activity, including improvements in Day 3 Sequential Organ Failure Assessment (SOFA) scores, increased ventilator-free days, and reductions in key inflammatory biomarkers including IL-6, IL-1β and circulating eNAMPT. ALT-100 also demonstrated a favorable safety profile, with treatment-emergent adverse events and serious adverse events comparable to placebo.

"The publication of the first 15 patients in the PUERTA study represents an important value inflection point for Aqualung," said Joe GN Garcia, M.D., Chief Executive Officer and Founder of Aqualung Therapeutics. "Beyond demonstrating favorable safety and encouraging biologic activity in critically ill ARDS patients, these findings provide the first clinical validation of eNAMPT as a therapeutic target in humans. This milestone strengthens our confidence in ALT-100 as a potential first-in-class platform therapy with applicability across multiple inflammatory and fibrotic diseases while further validating the scientific foundation of the Aqualung therapeutic platform."

ARDS remains a devastating syndrome with significant mortality and currently has no FDA-approved pharmacologic therapy. Because eNAMPT is a central regulator of innate immune activation, inflammation and fibrosis, Aqualung believes successful clinical validation in ARDS strengthens the rationale for evaluating ALT-100 across additional high-value pulmonary and systemic inflammatory diseases, including progressive pulmonary fibrosis.

The publication also provides independent, peer-reviewed validation of Aqualung's scientific approach and supports continued clinical advancement of ALT-100 together with the Company's proprietary eNamptor™ precision medicine platform, which combines therapeutic intervention with genomic/biomarker-based patient identification.

Building on these findings, Aqualung is evaluating the optimal clinical development strategy for ALT-100 across inflammatory and fibrotic indications while continuing to expand the clinical utility of the eNamptor™ platform.

About Aqualung Therapeutics

Aqualung Therapeutics is a clinical-stage biotechnology company developing first-in-class therapeutics targeting the extracellular nicotinamide phosphoribosyltransferase (eNAMPT) pathway for severe inflammatory, fibrotic and immune-mediated diseases. The Company's proprietary eNamptor™ platform integrates ALT-100, a first-in-class eNAMPT-neutralizing monoclonal antibody, with biomarker and precision medicine technologies designed to identify patients at greatest risk for disease progression and those most likely to benefit from therapy. Aqualung is advancing ALT-100 for ARDS, pulmonary fibrosis and other serious diseases characterized by dysregulated inflammation and fibrosis.

For more information on Aqualung's therapeutic programs, visit www.aqualungtherapeutics.com.

Media Contacts

Joe GN Garcia, MD
Chief Executive Officer & Founder
+1-312-618-7337
skip@aqualungtherapeutics.com

Stan Miele
President & Chief Business Officer
+1-919-410-0504
stan@aqualungtherapeutics.com

Stanley Miele
Aqualung Therapeutics Corp.
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