TUCSON, AZ / ACCESSWIRE / July 5, 2022 / Aqualung Therapeutics, an early stage immunotherapeutics biotech company developing an anti-inflammatory therapeutic platform for serious unchecked inflammatory disorders, announced today that their first two patients have been enrolled in the phase 1A healthy human volunteer Study. The data from this study will be used to understand and validate dosing and safety of the humanized monoclonal antibody therapeutic ALT-100 for future clinical trials that address diseases driven by unchecked inflammation.
The lead indication of ALT-100 is an acute inflammatory lung condition called Acute Respiratory Distress Syndrome or (ARDS) that has no FDA-approved therapy and a mortality rate reaching 40%. Inflammation is a key feature in the pathogenesis of ARDS and the investigational product (IP) ALT-100 is an anti-inflammatory therapeutic that specifically binds to a master regulator of inflammation; the eNAMPT protein. eNAMPT plays a central role in managing runaway inflammation that is seen in critical care conditions such as ARDS, and also the inflammation caused by exposure to mechanical ventilation. This initial Phase 1A study is the first step in determining safety and tolerability of ALT-100 before conducting a more robust P2A study in ARDS patients.
This First in Human (FIH), Phase 1, randomized, double-blind, placebo-controlled study will investigate the safety, tolerability, and PK profile of single ascending doses of IV infused ALT-100 administered in healthy participants. The 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) to one of 4 planned single ascending dose (SAD) cohorts.
Joe GN Garcia MD, CEO and Founder of Aqualung Therapeutics states, "This is a real milestone for Aqualung. As a lifelong physician scientist, I am proud to be advancing a novel mAb such as ALT-100 to a potential place in the ICU or clinic. I am passionate about finding solutions for diseases such as ARDS and this initial trial is the first step to proving this therapeutic mAb will make a real difference in reducing hospitalization and saving lives for those afflicted with the vexing condition of ARDS and ventilator-induced lung injury. Additionally, 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 certainly destined to be a game changer in treating unchecked inflammation."
While this study is being executed in Australia, Aqualung is filing an Investigational New Drug Application (NDA) with the US FDA in the coming days. "The study design was previously discussed with the FDA so there is great confidence in the overarching objective and design of this P1A study", states Stan Miele, President of Aqualung Therapeutics. "Our collaborators in both the US and Australia have done a superb job submitting all the necessary regulatory documents to ensure a successful launch of this study. Our CRO partner CMAX is aggressively enrolling potential candidates for this trial, and to date there has been great reception to participate in a study that may have the potential to reduce hospitalization and save lives. We have great confidence in their altruistic recruitment campaign, and this should lead to consistent study enrollment over the coming months. CMAX is a top-tiered Clinical Research group, and they have a superior facility for conducting clinical trials."
About Aqualung Therapeutics Corporation
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 extracellular nicotinamide phosphoribosyltransferase (eNAMPT) as a contributor to inflammatory disease severity and mortality.Aqualung Therapeutics has developed eNamptor™, a Next Gen platform comprised of i) ALT 100 mAb, a humanized eNAMPT-neutralizing monoclonal antibody; ii) eNAMPT-Plex, a plasma-based biomarker panel comprised of cytokines, including eNAMPT, which predicts inflammatory disease mortality; and iii) NAMPT-Gene, a genotyping assay that identifies individuals at increased risk for severe inflammatory disease and death. The pipeline of ALT is designed to target a range of diseases, including ARDS, ventilator- and radiation-induced lung injury, intra-amniotic inflammation (chorioamnionitis), prostate cancer, pulmonary hypertension, and organ fibrosis (pulmonary, cardiac hepatic fibrosis or NASH). Each of these conditions exhibit significant morbidity and mortalityand represent significant unmet medical needs. For additional information about the company, please visit www.aqualungtherapeutics.com.
SOURCE: Aqualung Therapeutics
View source version on accesswire.com: