TUCSON, AZ / ACCESSWIRE / September 21, 2022 / Aqualung Therapeutics, an immunotherapeutics biotech company with an anti-inflammatory and anti-fibrosis therapeutic platform for serious unchecked inflammatory and fibrotic disorders, has been awarded two 3-year NIH FAST-TRACK AWARDS [R42DK135208; R42HL160422) to support development of ALT-100, a humanized monoclonal antibody (mAb) therapy for the chronic indications of Pulmonary Arterial Hypertension (PAH) and Inflammatory Bowel Disease (IBD). The ALT-100 mAb targets the inflammation-inducing damage-associated molecular pattern protein eNAMPT, and is currently in Phase 1A human safety trials.
Curative medical therapy for IBD (both Crohn’s Disease and Ulcerative Colitis) patients does not currently exist. Optimal management is an early induction of remission followed by a sustained and durable period of steroid-free remission and long-term maintenance to prevent relapse. For active Crohn’s Disease (CD), the treatment algorithm starts with steroids, enteral nutrition, 5-ASA therapy, and can evolve to anti-TNFa agents (infliximab, adalimumab, vedolizumab etc). Unfortunately, 30-50% of IBD patients with severe disease who are initiated on anti-TNFa biologic therapy, fail to achieve remission due to lack of drug response, loss of response, drug intolerance, or severe side effects that require cessation of therapy. Aqualung’s R42 Fast Track STTR award will address this unmet need for a new therapeutic modality to treat severe, difficult to treat IBD patients utilizing ALT-100; a humanized mAb that neutralizes the potent inflammatory regulator eNAMPT (extracellular nicotinamide phosphoribosyltransferase). eNAMPT is a novel IBD therapeutic target and regulator of innate immunity. ALT-100 mAb will be developed as a potentially impactful therapeutic intervention to reduce the inflammation & fibrosis associated with IBD severity.
Pulmonary arterial hypertension (PAH) is a rare, progressive often-fatal disease characterized by elevated pulmonary vascular resistance (PVR) that leads to right ventricular (RV) failure and ultimately death. The median survival of patients with idiopathic PAH is ~2.8 years without effective treatment. Current PAH treatments only variably limit clinical deterioration, fail to reverse PAH vascular remodeling, vessel stiffening, and narrowing, and do not significantly prolong survival. Supported by compelling published data Aqualung’s R42 Fast Track STTR award will further develop the eNAMPT-neutralizing humanized ALT-100 mAb as a highly novel PAH therapeutic target to reduce PAH severity and outcomes.
“It is evidently clear that the utility of ALT-100 now goes well beyond the initial indication of ARDS, and the published pre-clinical evidence of ALT-100 demonstrates how this novel therapeutic has both anti-inflammatory and anti-fibrotic properties” states Stan Miele, President & CBO of Aqualung Therapeutics. “We are pleased the NIH echoes our belief that ALT-100 and the target of eNAMPT is central to IBD and PAH. Both disease states need additional alternatives to existing FDA-approved therapies, and we believe ALT-100 will play a pivotal role for those who fail TNF-a therapy for IBD, and for those looking for more of a curative therapy for the condition of PAH. “
These two NIH STTR Awards will confirm the efficacy of subcutaneously delivered ALT-100 mAb as well as appropriate dosing schedules in both IBD and PAH pre-clinical animal models, and provide financial support for the IND-enabling PK, PD and toxicology studies.
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
www.aqualungtherapeutics.com
Joe GN Garcia MD
Tel: +1-312-618-7337
skip@aqualungtherapeutics.com
Stan Miele
+1-919-410-0504
stan@aqualungtherapeutics.com
SOURCE: Aqualung Therapeutics