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Aqualung Therapeutics Receives FDA Clearance of its IND for Acute Respiratory Distress Syndrome

– Aqualung will continue the P1A Healthy Human Volunteer Trial and complete the trial first half of 2023

– The Phase 2A study (PUERTA) will be initiated in the 2nd half of 2023

– ALT-100 is the first humanized mAb therapy that targets the eNAMPT protein which plays a pivotal role in regulating inflammation and fibrosis

Aqualung Therapeutics, an immunotherapeutics biotech company today announced that the U.S. Food and Drug Administration (FDA) has cleared the IND, enabling the company to proceed with continuation of the on-going human clinical trial for ALT-100 in healthy human volunteers. The P1A study has already dosed two of the four dosing cohorts and should be completed by the middle of 2023. Upon successful completion of the P1A study, Aqualung will initiate a P2A (PUERTA - Pioneering the Utility of eNAMPT Reducing Therapies in ARDS/VILI) study in moderate to severe Acute Respiratory Distress Syndrome (ARDS) patients. The P2A ARDS study will be a multicenter study with ~90 moderate to severe ARDS subjects and be conducted in ~ 8 U.S. based Hospitals.

"We must reflect on the reality that there are NO FDA-approved therapies for the treatment of ARDS other than supportive care and mechanical ventilation. This is a vexing condition that still has a mortality rate approaching 40%", states Joe GN Garcia MD, CEO and Founder of Aqualung Therapeutics. "We are excited to bring a first-in-class mAb therapy to the clinic with the potential to meaningfully impact people who experience ARDS in the hospital setting. We look forward to continuing our ongoing P1A study and eventually testing our unique approach of targeting eNAMPT proteins in moderate to severe ARDS subjects. eNAMPT plays a central role in managing unchecked inflammation and fibrosis, both which contribute to ARDS morbidity and mortality. As eNAMPT is also one of the highest expressed proteins for patients placed on mechanical ventilation, our large animal preclinical data strongly suggests ALT-100 is effective in blocking the cytokine storm associated with ventilator induced lung injury; resulting in fewer days on the ventilator, fewer days in the hospital ICU and ultimately saving lives."

"We want to thank all Aqualung team members and advisors, including the FDA for getting this novel therapy to this incredible milestone", states Stan Miele, President and CBO of Aqualung Therapeutics. "This journey began years ago to find a solution to those inflicted with ARDS and Ventilator Induced Lung Injury. We have methodically taken every step necessary (pre-clinical studies, PD/PK/small and large animal toxicology, and manufacturing) to prove this novel therapeutic is both effective and safe; and the FDA agrees we can move this into human clinical trials."

About ALT-100 ALT-100 is a humanized, monoclonal antibody that targets an upstream protein called eNAMPT (nicotinamide phosphoribosyl transferase). eNAMPT plays a central role in attenuating inflammation and fibrosis. With over 8 published articles demonstrating the clinical utility of ALT-100, it has been shown to dramatically improve lung function by greater than 50% in animals induced with septic shock and ARDS, and also reduced numerous inflammatory markers by greater than 50%. This large animal porcine data is most replicable to human disease state expectations.

The ALT-100 clinical trial in healthy human volunteers includes a one-time, 20-minute infusion per course of therapy. This is a single ascending dose study with four doses, plus placebo. The P2A PUERTA study also involves two different doses vs a placebo in moderate to severe ARDS subjects, and each patient will receive a 20-minute IV infusion of ALT-100 upon diagnosis of moderate to severe ARDS. The timing of ALT-100 infusion will play an important role in attenuating runaway inflammation and further demonstrate the safety and efficacy of ALT-100 in this patient population.

About Aqualung Therapeutics Corporation Aqualung is an early-stage biotech company developing immune-focused therapeutic platform, eNamptor™. This anti-inflammatory and anti-fibrotic therapeutic platform is comprised of: i) ALT-100 mAb, a humanized eNAMPT-neutralizing mAb; ii) eNAMPT-Plex, a plasma-based multi-cytokine biomarker panel (including eNAMPT) which predicts inflammatory disease mortality; and iii) NAMPT-Gene, a genotyping assay that identifies individuals at increased risk for severe inflammatory disease and death. Aqualung's science-driven approaches are based upon a seminal discovery by Aqualung CEO and Founder, a physician scientist, who identified extracellular nicotinamide phosphoribosyltransferase (eNAMPT) as a contributor to inflammatory disease severity and mortality. Aqualung Therapeutics has developed a pipeline of ALT-100 mAb indications targeting inflammatory and fibrotic disorders: ARDS, ventilator- and radiation-induced lung injury, intra-amniotic inflammation (chorioamnionitis), pulmonary hypertension, prostate cancer, and organ fibrosis (pulmonary, cardiac, hepatic/NASH). Each of these conditions exhibit significant morbidity and mortality and represent significant unmet medical needs.

For additional information about the company, please visit

Aqualung Therapeutics Corporation

Joe GN Garcia MD Tel: +1-312-618-7337

Stan Miele +1-919-410-0504

SOURCE: Aqualung Therapeutics


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