Aqualung Therapeutics, an early-stage biotech company developing an immune-focused, anti-inflammatory therapeutic platform for unchecked inflammation in patients with serious acute and chronic diseases, has been awarded a one year NIH FAST-TRACK AWARD (1R41 HD101202-01A1) to support development of a humanized antibody therapy for pregnant women with intrauterine infection at risk for preterm birth.
Each year over 400,000 preterm births occur annually in the US, the majority born to mothers with “chorioamnionitis” or intrauterine infection that occurs before or during labor. The name refers to the infection of the membranes surrounding the fetus: the “chorion” (outer membrane) and the “amnion” (fluid-filled sac) leading to a preterm birth and/or serious infection in the mother and the baby. Preterm births are at risk for a myriad of serious lung, gastroenterology, and cognitive complications as well as developmental delays.
Aqualung Therapeutics (ALT) scientists have identified extracellular NAMPT or eNAMPT, a master regulator of tissue and systemic inflammation as a novel therapeutic target in Chorioamnionitis. ALT has demonstrated robust NAMPT expression in placentas from women with chorioamnionitis. In a preclinical pregnant mouse model of ChorP, a eNAMPT-neutralizing antibody was dramatically protective, improving preterm birth mortality and inflammation in newborn pups.
This NIH STTR Award will drive the final selection of the lead eNAMPT-neutralizing humanized therapeutic mAb between two candidates, ALT-100 and ALT-200; with selection utilizing in vitro and preclinical in vivo models of chorioamnionitis. Upon confirmation of the optimal mAb candidate in treating chorioamnionitis, Aqualung will submit an R42 STTR grant to further support pre-clinical development and IND-enabling studies.
“This is the fourth NIH-supported indication for development of the eNAMPT platform along with ARDS, pulmonary hypertension and radiation lung injury. We are excited the NIH sees the value of our science and is willing to fund our early proof of concept development,” states Stan Miele President of Aqualung Therapeutics.