Aqualung Therapeutics Advances Its Investigational Monoclonal Antibody into Ind-Enabling Studies of Acute Respiratory Distress Syndrome (ARDS) And Ventilator-Induced Lung Injury (VILI)

Aqualung Therapeutics Corporation is developing ALT-100, a therapeutic monoclonal antibody, to combat serious unchecked inflammation. The initial application aims to reduce the mortality of Acute Respiratory Distress Syndrome (ARDS) and Ventilator-Induced Lung Injury (VILI). This offers a potential option in the treatment of COVID-19, which causes severe pneumonia and respiratory failure and can be compounded by mechanical ventilation, resulting in multi-organ failure and death.

The Company is actively engaged with government agencies such as the National Institutes of Health & the Department of Defense for additional funding opportunities and has begun required testing as part of the Investigational New Drug (IND) regulatory package for the FDA.

“Antibacterial agents, antiviral agents and methylprednisolone to date have been largely ineffective in viral-induced ARDS and according to early reports, in NCIP-induced ARDS,” said Joe G.N. Garcia MD, CEO and Founder of Aqualung Therapeutics (ALT) and globally-recognized expert on ARDS. “There is a serious and ongoing unmet therapeutic need for COVID-19 therapies with a case fatality rate estimated to be ~2-3% as well as for the nearly 500,000 ARDS patients in the U.S. alone who annually develop ARDS from sepsis, trauma and a myriad of diverse stimuli and experience 30-40% mortality.”

Specifically, Aqualung Therapeutics is developing eNamptor™, a Next Gen platform comprised of:

1)      ALT-100, a humanized eNAMPT-neutralizing monoclonal antibody (ALT-100);

2)      eNAMPT-Plex, a plasma-based biomarker panel comprised of cytokines, including eNAMPT, which predicts ARDS mortality; and

3)      NAMPTGene, a genotyping assay that identifies individuals with NAMPT genetic variants at increased risk for ARDS death.

“We hope to quickly finalize our manufacturing agreements and get ALT-100 into the Emergency Room and ICU to address this significant unmet medical need as soon as possible, during not only this current COVID-19 crisis but in the future”, states Stan Miele, President of Aqualung Therapeutics.”

Aqualung Therapeutics identified an upstream protein, extracellular nicotinamide phosphoribosyltransferase (eNAMPT) and its receptor, Toll-like receptor 4 (TLR4) which are important in regulating the upstream inflammatory cascade that contributes to ARDS morbidity and mortality. Supported by strong preclinical and human data, combining the elements of the eNamptor™ platform technology has the potential to define high risk ARDS individuals as well as identify patients most likely to respond to ALT-100 and reduce downstream inflammation that contributes to death from COVID-19 infection and NCIP-induced ARDS.

In December 2019, a novel coronavirus, SARS-CoV-2, was found to produce COVID-19 infection in humans with clusters of acute respiratory illness in Wuhan, China, now known as novel coronavirus–infected pneumonia (NCIP).

Deaths due to coronavirus COVID-19 infection primarily occur in patients transferred to the ICU with NCIP. These patients have or develop severe respiratory distress, respiratory failure and full blown ARDS. In such cases, treatment requires placement on a ventilator and mechanical ventilation for respiratory failure.

Patients with NCIP-induced ARDS often succumb to multi-organ failure due to two life-threatening mechanisms. First, the organ failure that occurs is a direct result of unremitting inflammation generated by the virus-activated innate immunity pathways designed to contain the viral infection. A second and very important threat is the activation of inflammatory pathways by exposure to the increased mechanical stress to the lung created by exposure to mechanical ventilation.

Activation of these evolutionarily-conserved inflammatory pathways results in massive increases in the circulating levels of inflammatory cytokines which produce vascular leak, edema of multiple critical organs (lung, kidneys, heart, brain, liver, GI tract) and ultimately result in multi-organ dysfunction and death. The overall inflammatory burden produced by the virus and by use of the mechanical ventilation drives the occurrence of severe, and often fatal organ failure.

Aqualung is an early stage biotech company developing immune-focused therapeutic antibodies for patients suffering from disorders characterized by acute and chronic lung and systemic inflammation. Founded in 2016 and led by a physician scientist, Aqualung’s science-driven approaches led them to the identification of nicotinamide phosphoribosyltransferase (NAMPT) and other key proteins expressed in both acute and chronic inflammatory diseases. The pipeline of ALT is designed to target a range of diseases, including ARDS, ventilator- and radiation-induced lung injury, prostate cancer, pulmonary hypertension and pulmonary fibrosis. These conditions all exhibit a significant unmet medical need with significant morbidity and mortality. For additional information about the company, please visit www.aqualungtherapeutics.com.

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