Harnessing and treating inflammatory and fibrotic diseases of today with a novel therapy of tomorrow

Aqualung Therapeutics Corporation, a Tucson, AZ- and Jupiter FL-based early stage biotech company with subsidiaries in Australia, is led by experienced life science executives and entrepreneurs with expertise in Inflammation and Fibrosis, Precision Medicine, Drug Development, Drug Manufacturing and Commercialization. They are committed to exploring eNAMPT as a key target and to applying the novel biologic therapeutic ALT-100 mAb to address the “unchecked inflammation and fibrosis” elicited by dysregulated innate immunity pathways in a variety of acute and chronic conditions with significant unmet therapeutic needs.

As an organization we are committed to finding novel targets in the treatment of inflammatory diseases. We are working collaboratively with the FDA to ensure both acute and chronic inflammatory diseases that have a significant unmet medical need receive the appropriate review. Where necessary we will be seeking priority review for specific indications based on epidemiology.

ROADMAP

Key Milestones for Aqualung

2005

Genomics research identifies NAMPT as a key target for acute lung injury

2008

Polyclonal antibody eNamptor blunts/attenuates ventilator induced lung injury model

2014

NAMPT influences genes that predict cancer mortality

2017

ALT-100 shown to be a therapeutic target in preclinical models of pulmonary hypertension

July 2019

Selection of lead ALT-100 mAb candidate

July 2020

Initiate Manufacturing ALT-100 with CMAB/Wuxi Biologics

September 2021

IND Enabling Large Animal Toxicology Study initiated

June 2022

Submit IND U.S. FDA ARDS indication for ALT-100

2005-2007

NAMPT Genetic Variants shown to confer risk and severity of inflammatory injury

2011

Aqualung receives a Phase I STTR award to develop murine monoclonal antibodies against eNAMPT

2015

Nampt mechanism of action elucidated by Aqualung scientists via TLR4 signaling

2019

Successful Humanization of mouse NAMPT monoclonal antibodies

January 2020

IND Studies for Acute Respiratory Distress Syndrome to begin

August 2021

GMP Manufacturing ALT-100 completed

June 2022

Initiate Phase 1A First in Human Study (Australia)