First Patient Enrolled in the PUERTA Phase 2A ARDS Clinical Trial: Treatment with Aqualung Therapeutics ALT-100 mAb

  • A total of 14 PUERTA participating sites, 12 US and 2 Australian, in the Phase 2A trial of ALT-100 mAb in moderate to severe ARDS
  • Aqualung awarded a $3M NIH R44 grant supporting the PUERTA Phase 2A Clinical Trial

TUCSON, AZ and JUNO BEACH, FL / ACCESSWIRE / December 5, 2023Aqualung Therapeutics, an early stage immunotherapeutics company with an anti-inflammatory and anti-fibrotic therapeutic platform for life-threatening unchecked inflammation/fibrosis, today announced that the first patient has been enrolled in a Phase 2A clinical trial evaluating the safety and efficacy of ALT-100 mAb for the treatment of adults with moderate/severe Acute Respiratory Distress Syndrome (ARDS) and Ventilator Induced Lung Injury. (VILI). The ALT-100 mAb is an investigational first-in-class monoclonal antibody therapeutic targeting extracellular NAMPT or eNAMPT, a master regulator of systemic inflammation and fibrosis that was identified by Dr. Garcia as a novel therapeutic target and major contributor to the severity of ARDS and other severe disorders characterized by inflammation and organ fibrosis. eNAMPT is one of the most highly expressed proteins in ARDS driving inflammation and sustaining unremitting inflammation when patients are placed on mechanical ventilation.

ARDS is a vexing condition which affects ~500K people in the US and over 2M annually on a global basis. With a mortality rate of 40% and no FDA-approved therapies other than supportive care, there remains a significant unmet medical need for novel therapies. The initiation of the study is at the start of the U.S. flu season where there is an increase in hospitalizations and ARDS cases.

“Aqualung has had this important milestone on our calendars for years and we have high expectations for the use of ALT-100 mAb in moderate/severe ARDS subjects” states Stan Miele, President of Aqualung Therapeutics. “The PUERTA study is uniquely designed to administer our therapeutic drug at the time of moderate/severe ARDS diagnosis, which is an important differentiator to many other drugs that have been tested or are being tested in this space. As unchecked inflammation is a major contributor to negative patient outcomes, we believe the sooner ALT-100mAb is administered to patients, it can dramatically attenuate the inflammatory cytokine storm and improve patient outcomes.”

Joe GN Garcia MD, CEO and Founder of Aqualung states; “this has been personal mission for the last 30 years to develop and find a novel target/therapeutic that will improve the outcome of patients diagnosed with ARDS. The compelling results of our human biomarker and genetic studies in subjects with ARDS combined with the dramatic efficacy of the ALT-100 mAb in preclinical mouse, rat and porcine ARDS models, gives me great confidence that we have the right target and therapeutic drug to improve patient outcomes. We believe that ALT-100 mAb has the real promise of reducing the number of days on mechanical ventilation or abolishing the need for mechanical ventilation. Both outcomes undoubtedly will translate to a demonstrated mortality benefit. The chosen PUERTA study sites in the US and Australia are all led by experienced and very talented physicians who are committed to recruiting ARDS subjects in the coming months.”

Additionally, Aqualung received a two year, $3M R44 NIH grant to support the Phase 2A PUERTA clinical trial in US hospital sites. Aqualung has enjoyed long standing support from the NIH which was instrumental in completing key proof of concept pre-clinical ARDS/VILI studies in rodent and porcine models as well as in supporting the IND-enabling toxicology studies with ALT-100 mAb. This strong private/public collaboration between the NIH and Aqualung highlights the shared commitment to exploring impactful solutions for the treatment of ARDS.

About Aqualung Therapeutics Corporation

Aqualung is an early-stage biotech immunotherapeutics company which has developed an anti-inflammatory therapeutic platform for patients with life-threatening unchecked inflammation. Founded in 2016 and led by a physician-scientist, Aqualung’s science-driven approaches led to the identification of nicotinamide phosphoribosyltransferase (NAMPT) as a major contributor to the severity of potentially fatal inflammatory diseases. Aqualung Therapeutics has developed eNamptor™, a Next Gen platform comprised of: i) the humanized ALT 100 mAb, an eNAMPT-neutralizing monoclonal antibody; ii) eNAMPT-Plex, a plasma-based biomarker panel comprised of cytokines and eNAMPT, which predicts ARDS mortality; and iii) NAMPT-Gene, a genotyping assay that identifies individuals genetic variants that predispose to ARDS risk and death. In addition to ARDS and ventilator-induced lung injury, the pipeline of ALT-100 mAb indications currently includes intrauterine infection during pregnancy (chorioamnionitis), prostate cancer, pulmonary hypertension, autoimmune disorders (IBD, SLE) and fibrosis of cardiac (post ischemic), pulmonary (IPF, radiation) and hepatic tissues (NASH). Each of these potentially fatal inflammatory conditions share the significant unmet medical need for therapeutics that reduce morbidity and mortality. For additional information about the company, please visit

Aqualung Therapeutics Corporation
Tel: +1- 312-618-7337; +1-919-410-0504

Joe GN Garcia MD

Stan Miele

SOURCE: Aqualung Therapeutics,

Posted in AZBio News.