First in human subjects enrolled in Aqualung Therapeutics’ Phase 1A study evaluating the safety, tolerability, and pharmacokinetics of ALT-100

TUCSON, AZ /ACCESSWIRE/July 5, 2022/ Aqualung Therapeutics, an early-stage immunotherapy biotechnology company developing an anti-inflammatory therapeutic platform for severe, uncontrolled inflammatory disorders, today announced that its first two patients have been enrolled in the Phase 1A study in healthy human volunteers. The data from this study will be used to understand and validate the dosage and safety of the humanized monoclonal therapeutic antibody ALT-100 for future clinical trials in diseases caused by uncontrolled inflammation.

The main indication for ALT-100 is an acute inflammatory lung condition called acute respiratory distress syndrome or (ARDS) that has no FDA-approved treatment and a mortality rate of up to 40%. Inflammation is a key feature in the pathogenesis of ARDS and investigational product (IP) ALT-100 is an anti-inflammatory treatment that specifically binds to a master regulator of inflammation; the eNAMPT protein. eNAMPT plays a central role in managing rampant inflammation seen in critical care conditions such as ARDS, as well as inflammation caused by exposure to mechanical ventilation. This initial Phase 1A study is the first step in determining the safety and tolerability of ALT-100 before conducting a more robust P2A study in patients with ARDS.

This first-in-man (FIH), Phase 1, randomized, double-blind, placebo-controlled study will investigate the safety, tolerability, and pharmacokinetic profile of single escalating doses of ALT-100 by intravenous infusion administered to participants in good health. PD effects and immunogenicity of ALT-100 will also be explored. The study is being conducted at a single clinical center (CMAX) in Australia. There will be 32 evaluable participants who will be sequentially enrolled and randomized in a 3:1 ratio (active:placebo) into one of 4 planned single ascending dose (SAD) cohorts.

Joe GN Garcia MD, CEO and Founder of Aqualung Therapeutics, says, “This is a real milestone for Aqualung. As a long-time medical scientist, I am proud to advance a new mAb such as ‘ALT-100 towards a potential place in the ICU or I am passionate about finding solutions for diseases such as ARDS and this initial trial is the first step in proving that this therapeutic mAb will make a real difference in reducing hospitalizations and saving lives for those with the vexing condition of ARDS and ventilator-induced lung injury.Furthermore, I am proud of the great work of my internal team and the many collaborators who have made this possible. Aqualung’s ALT-100 is sure to be a game-changer in the treatment of uncontrolled inflammation.

While this study is running in Australia, Aqualung is filing an Investigational New Drug Application (NDA) with the US FDA in the coming days. “The study design has already been discussed with the FDA, so there is great confidence in the overall goal and design of this P1A study,” said Stan Miele, president of Aqualung Therapeutics. “Our collaborators in the United States and Australia have done an excellent job of submitting all necessary regulatory documents to ensure the successful initiation of this study. Our CRO partner CMAX is actively recruiting potential candidates for this trial, and to date, it was very well received to participate in a study that may have the potential to reduce hospitalizations and save lives. We have great confidence in their selfless recruitment campaign, and this should lead to continued enrollment in the study. over the next few months. CMAX is a leading clinical research group, and they have superior facilities to conduct clinical trials.”

About Aqualung Therapeutics Corporation

Aqualung is an early-stage biotechnology company developing immune-targeting antibody therapeutics for patients suffering from disorders characterized by acute and chronic pulmonary and systemic inflammation. Founded in 2016 and led by a medical scientist, Aqualung’s scientific approaches led it to identify extracellular nicotinamide phosphoribosyltransferase (eNAMPT) as a contributing factor to the severity and mortality of inflammatory diseases. Aqualung Therapeutics has developed eNamptor™, a Next Gen platform composed of i) ALT 100 mAb, a humanized eNAMPT neutralizing monoclonal antibody; ii) eNAMPT-Plex, a plasma-based biomarker panel composed of cytokines, including eNAMPT, which predicts mortality from inflammatory disease; and iii) NAMPT-Gene, a genotyping test that identifies people at increased risk of serious inflammatory disease and death. ALT’s pipeline is designed to target a range of diseases including ARDS, ventilation and radiation induced lung injury, intra-amniotic inflammation (chorioamnionitis), prostate cancer, pulmonary hypertension and organic fibrosis (pulmonary fibrosis, hepatic heart or NASH). ). Each of these conditions has significant morbidity and mortality and represents significant unmet medical needs. For more information about the company, please visit www.aqualungtherapeutics.com.

Aqualung Therapeutics Corporation
www.aqualungtherapeutics.com
Such. : +1-312-618-7337/+1-919-410-0504
Joe GN Garcia MD/Stan Miele
E-mail; [email protected]; [email protected]

THE SOURCE: Therapeutic Aqualung

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