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TUCSON, AZ, December 12, 2022 /24-7PressRelease/ -- AquaLung Therapeutics gets listed on THE OCMX™
Aqualung Therapeutics, a clinical stage immunotherapeutics company with an anti-inflammatory and anti-fibrotic therapeutic platform for life-threatening unchecked inflammation/fibrosis continues to advance it's lead therapeutic mAb ALT-100 in human clinical trials.
The company has dosed 75% of the patients in the first healthy human volunteer study and will conclude dosing by early January 2023. There will be an end of phase 1 meeting with the FDA in March 2023, and the company expects to initiate a pivotal P2A study in moderate/severe Acute Respiratory Distress Syndrome (ARDS) patients by mid-2023.
This is the lead indication for Aqualung's therapeutic, designed to address a major unmet medical need of this vexing condition: a 30-40% mortality rate with no FDA approved therapies.
The target for ALT-100 is a novel protein discovered by Aqualung scientists called eNAMPT, and this protein is a master regulator and driver of severe unchecked inflammation. This protein increases 3-10-fold when there is an injurious stimuli such as ARDS and unless kept in check, it will lead to dramatic levels of systemic inflammation, organ failure and potential mortality for patients.
The OCMX™ is pleased to announce the listing of AquaLung Therapeutics to its online portal which offers financial networks the ability to learn more about this exciting opportunity.
The OCMX™ has spent considerable time completing its due diligence on AquaLung Therapeutics and concluded that there is indeed a tremendous potential for this company.
The OCMX™ noted that AquaLung Therapeutics exhibits the main components of any solid opportunity, namely a solid management team, a great track record, and several key competitive advantages.
PROBLEM THEY ARE SOLVING
The problem is too may people are dying of ARDS and there are NO FDA approved therapies. This therapy unlocks the key to attenuating runaway inflammation when patients are diagnosed with sepsis, severe viral or bacterial pneumonia, severe Covid 19, trauma or hypoxia (lack of oxygen).
The drug ALT-100 mAb has proven in numerous animal models (including a large animal porcine model most replicable to humans) to reduce inflammatory markers by _50% while also demonstrating a _ than 50% improvement in overall lung function parameters.
This will result in less days in the ICU, less days on mechanical ventilation, saving lives and dramatic financial savings to health care.
WHERE THEY ARE HEADED
This $10M series A financing will allow the company to conclude a Ph1A study to validate efficacy and safety, and by mid 2023 to initiate and complete a 90 patient P2A study in moderate/severe ARDS subjects. It will also fund the company's ability to conclude animal repeat dosing toxicity for the chronic indications of radiation pneumonitis & fibrosis, and pulmonary arterial hypertension.
Within 30 months the company will have a completed P2A study in ARDS, and an IND submission for two chronic indications and should lead to a licensing agreement with the likes of big Pharma who are looking for products that target innate immunity. Active discussions with Pharma companies are ongoing and we already have two in active diligence.
• Validated target protein that is novel and the master regulator of inflammation and fibrosis in the human body.
• De-risked investment due to cGMP material on hand (3500 doses) for use in human studies coupled with an IND from the US FDA for the ARDS indication. The only company to ever demonstrate in a large animal porcine sepsis/ARDS/VILI model the use of a therapeutic drug that had a greater than 50% reduction in inflammatory markers, and also yielded a greater than 50% improvement in lung function indices. This is most replicable to expectations in humans.
• Validated mechanism of action on how the drug ALT-100 mAb works in the body and preserves vital organ function and can save lives. Low COGs are based on tremendous affinity to the eNAMPT protein.
• Already completed 75% of the P1A study in humans with NO serious adverse events.
• Funding to date has been the US government with approximately 70% of our funding to date (_$25M USD) coming from the NIH and department of defense.
• Peer reviewed, published data (8 publications) which shows validated scientific rigor.
• Strong IP (composition of matter and method of use patents). Licensing agreement in place for China and specific Asian markets.
Joe GN Garcia MD. – CEO and Founder
World renowned physician scientist. National Academy of Medicine. Former chair of critical care, Johns Hopkins and ran University of Chicago and University of IL and University of Arizona Health Systems. Over 500 publications and a leader in inflammation research.
Stan Miele – President and CBO
Over 30+ years in life sciences and biotech. Former president (6 years) of Sucampo Pharma Americas. Private and Public company experience; launched and successfully commercialized numerous pharmaceutical products globally. Established multiple global licensing agreements and established subsidiaries in Europe and Australia. Chief Commercial officer for several companies and experience in IPOs, private placements and all forms of capital raises.
• Initiation of the P1A human study.
• IND approval by the FDA for the indication of ARDS within the 30-day time frame and NO questions from the FDA on the protocol or the animal toxicology data.
• Closed two convertible notes totaling $3.8M dollars.
• Received over $25M in NIH grants with the government as the biggest investor.
• Won two state awards in 2022 (Fast Lane award from Arizona Bio to the company that achieves the greatest milestones within a 12-month period) and Tech Launch Arizona 2022 startup company of the year.
• Composition of matter patent granted (through 2041). Collaborative interaction with the FDA with comments suggesting they want to "accelerate development of ALT-100" in indications such as radiation pneumonitis and fibrosis as this is a significant unmet medical need.
• Validated science through peer reviewed publications and over $25M in NIH and DOD grants.
• Validated target of eNAMPT which is the number one protein expressed when a patient is diagnosed with ARDS and ventilator induced lung injury.
• Strong IP position (composition of matter and method of use patents). World leader of eNAMPT research.
• Financially prudent clinical development program with a simplified cap table.
ABOUT THE OCMX™
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