Aqualung Therapeutics, an immunotherapeutics biotech company with an anti-inflammatory therapeutic platform for serious unchecked inflammatory disorders, announced the achievement of two key FDA milestones for their therapeutic mAb ALT-100. First is the successful FDA IND submission for the indication of Acute Respiratory Distress Syndrome (ARDS). Second is the scheduling of an FDA Pre-IND type B meeting (September 14th) to discuss the targeted use of ALT-100 mAb in Radiation-induced Lung Injury and Fibrosis.
In addition to achieving these key FDA milestones, Aqualung was recently the recipient of the “AZBio Fast Lane Award,” to be received at the annual AZBio Awards, (as part of Arizona Bioscience Week) and part of the White Hat Life Science Investor Conference (September 28/29), where Aqualung will also be a presenting company. This award is given to companies who demonstrated rapid progression in product development and are exceeding their milestones over the last 12 months. With ALT-100 mAb therapeutic now in a P1A healthy human volunteer study, coupled with the FDA interaction and continued NIH grants to further develop ALT-100, the company is barreling forward with ALT-100 in several inflammatory diseases with unmet medical needs.
“The milestones for Aqualung keep piling up as we continue to advance ALT-100 mAb through human clinical trials and into expanded indications of significant unmet medical needs” states Stan Miele, President & CBO of Aqualung Therapeutics Corp. “We are honored to be recognized as one of the faster, emerging biotech companies in Arizona, and as importantly we are excited to share our company thesis to a group of investors who will see the tremendous potential of a drug like ALT-100 in treating unchecked inflammation and fibrosis. As the company looks to close the first tranche of a series A, coupled with more awards from the NIH with the use of ALT-100, this puts Aqualung on a solid trajectory over the next 12 months.”
Aqualung is committed to addressing indications of unmet medical need for inflammatory and fibrotic disorders such as ARDS, which currently has no FDA-approved therapies and a mortality rate reaching 40%. As part of the IND submission, the FDA can provide significant insight and feedback into the overall designs of the P1A healthy human volunteer study and the ARDS P2A protocol. The Pre-IND Type B meeting in September will focus on the use of ALT-100 mAb in the chronic condition of radiation-induced lung injury and fibrosis, another significant unmet medical need. Feedback from the FDA on the proposed animal studies, along with the designed P1A/B human study in lung cancer patients receiving chemotherapy and radiation treatment will be very informative and provide a clear path of development that is agreed by the FDA.
“Our clinical Development, CMC and Regulatory teams have worked tirelessly to successfully complete all the necessary IND animal studies and human clinical trial designs to enable our ARDS IND filing. We are very confident the FDA will find our data to be comprehensive and compelling,” states Joe GN Garcia MD, CEO and Founder of Aqualung Therapeutics. “We intend to incorporate the FDA’s feedback and continue to execute our plans of advancing ALT-100 mAb beyond our ongoing Phase 1A safety study and into a Phase 2A POC study in ARDS subjects; which is an unbelievably vexing ICU condition. As Aqualung continues investor presentations, such as at White Hat during AZ Bio Week, we are confident and hopeful that other investors will see the great utility of ALT-100, appreciate the significant de-risking of our approach and recognize the tremendous progress the company has made. Investors are seeking novel therapies that can change the course of human health, and we hope they will see the value of our ALT-100 asset and join our other investors in participating in our series A capital raise.”
About Aqualung Therapeutics Corporation
Aqualung is an early-stage biotech company developing immune-focused therapeutic platform, eNamptor™. This anti-inflammatory and anti-fibrotic therapeutic platform is comprised of: i) ALT-100 mAb, a humanized eNAMPT-neutralizing mAb; ii) eNAMPT-Plex, a plasma-based multi-cytokine biomarker panel (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. Aqualung’s science-driven approaches are based upon a seminal discovery by Aqualung CEO and Founder, a physician scientist, who identified extracellular nicotinamide phosphoribosyltransferase (eNAMPT) as a contributor to inflammatory disease severity and mortality. Aqualung Therapeutics has developed a pipeline of ALT-100 mAb indications targeting inflammatory and fibrotic disorders: ARDS, ventilator- and radiation-induced lung injury, intra-amniotic inflammation (chorioamnionitis), pulmonary hypertension, prostate cancer, and organ fibrosis (pulmonary, cardiac, hepatic/NASH). Each of these conditions exhibit significant morbidity and mortality and represent significant unmet medical needs. For additional information about the company, please visit www.aqualungtherapeutics.com.
Aqualung Therapeutics Corporation
Joe GN Garcia MD/Stan Miele