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Antibody To Treat Lung Inflammation May Offer Potential in COVID-19

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Early stage biotech company Aqualung Therapeutics is currently developing a therapeutic monoclonal antibody – ALT-100 – for the treatment of unchecked inflammation.

COVID-19 can cause severe pneumonia and respiratory failure. Some patients require mechanical ventilation, an intervention which promotes inflammation. There is therefore a potential option to treat patients diagnosed with COVID-19 with ALT-100. The antibody has completed pre-clinical testing and Aqualung Therapeutics are hoping to accelerate approval and licensure processes in this critical time.

Technology Networks
recently spoke with Joe GN “Skip” Garcia, MD, Founder and Chief Executive Officer of Aqualung Therapeutics to learn more.

Molly Campbell (MC): For our readers that may be unfamiliar with Aqualung Therapeutics Corporation, please can you provide background on the company and its aims? 

Joe GN “Skip” Garcia (JG):
Aqualung Therapeutics is an early stage biotech company focused on developing therapeutic anti-inflammatory drugs for innate immunity-focused conditions.  We have a platform technology comprised of three elements: a therapeutic drug – the monoclonal antibody ALT-100 – a diagnostic biomarker and a genotyping assay. The latter two are designed to predict responders to our medication, which is very exciting since it represents personalized medicine. Our singular aim is to address conditions of unchecked inflammation, many of which are very serious and have a high mortality rates, including acute respiratory distress syndrome (ARDS). We want to save lives and reduce healthcare costs at the same time.

MC: Aqualung are developing a novel anti-inflammatory monoclonal antibody, ALT-100 to treat serious unchecked inflammation. Please can you tell us about the antibody's development and how it elicits a therapeutic effect?

Our therapeutic antibody is a next generation antibody; meaning it is highly specific and targeted to the upstream protein of eNAMPT and should have less adverse events.  eNAMPT is a potent inflammation-inducing protein whose levels in the blood increase (3 to 10-fold) in response to many injuries (infection, virus, trauma, ischemia etc). When this protein gets stimulated by an injury, it is highly secreted in the blood and it binds to a specific pro-inflammatory receptor, inducing a phenomenon called “cytokine storm”.  This serious unchecked inflammation leads to multi-organ dysfunction and ultimately death.  Our lead therapeutic ALT-100 neutralizes circulating eNAMPT, preventing further activation of other inflammatory receptors and reduces the magnitude of the cytokine storm.  In ARDS, the goal is to reduce the number of days patients are on a ventilator, and thereby save lives.  We have numerous preclinical models highlighting a dramatic reduction in unchecked inflammation, yet due to our mechanism of action, we maintain the capacity to thwart off bacteria if needed. 

MC: How could ALT-100 potentially be used in treating patients with COVID-19?

COVID-19 infection and pneumonia can lead to development of ARDS. Hyperactive immune inflammatory responses lead to fluid accumulation in the lung. This prevents oxygen absorption, the ability of the patient to breathe effectively and the failure of several vital organs.

Some patients that are diagnosed with COVID-19 develop a pulmonary hyperinflammation response, leading to severe pulmonary dysfunction and hospitalization. A subset of these patients will develop ARDS and be on mechanical ventilation, an intervention which itself promotes inflammation.

We believe that our therapeutic ALT-100, when administered at the time of intubation, will attenuate the downstream cytokine storm or runaway inflammation, reducing the days on the ventilator and helping to clear the lungs of fluid – a life saving measure.

MC: Please can you provide information on pre-clinical data in the testing of ALT-100? 

We have numerous pre-clinical models of trauma-, infection- and mechanical ventilation-induced advanced lung injury. Intravenous injection of our therapeutic antibody over a several minute infusion attenuates the level of the cytokine storm and dramatically reduces the severity of lung injury. All of the models show highly statistically significant improvement. 

At what stage in the development process is ALT-100 at present? Are there any plans in place to accelerate this?

We are in our investigational new drug (IND) enabling study(ies) phase. We are doing early PD/PK and toxicology studies and are looking to file an IND within 12 months. Our hope is to accelerate this due to the significant unmet medical need. We are in discussions with manufacturers who may be able to accelerate the appropriate timing of our mAb ALT-100 from 12 months down to 6 months. We do believe after we have a pre-IND meeting with the FDA this can be accelerated and (at a minimum) we expect fast track designation from the FDA. 

What challenges currently exist in the development of antibody-based therapeutics and in the licensure of such products? 

The biggest challenge is time. It takes time to make a humanized mAb and we are at the mercy of the clone expressing and growing in an optimal and timely manner. From a licensure perspective, the most successful drugs in the world – drugs like Humira – are mAbs and they are highly specific to their targets and can yield tremendous efficacy. We don’t see an issue with potential out-licensing if approached once we have some human safety and POC data. 

Joe G
N “Skip” Garcia , MD, Founder and Chief Executive Officer, Aqualung Therapeutics, was speaking with Molly Campbell, Science Writer, Technology Networks.