AzurRx BioPharma Announces Positive Preclinical Data with AZX1103

AzurRx BioPharma (NASDAQ:AZRX) today announces positive preclinical results for AZX1103, a b-lactamase enzyme combination product being developed for the prevention of hospital-acquired gastro-intestinal infections. AZ1103 is designed to be a complementary treatment for patients receiving antibiotics in the hospital setting. The results from the preclinical studies showed that AZX1103 had activity and degraded amoxicillin in the presence of clavulanic acid in the upper GI tract in the Gottingen minipig model.

As quoted in the press release:

“The data from these studies are very encouraging, showing AZ1103 to be safe and capable of inactivating amoxicillin, a member of the widely used class of b-lactam antibiotics,” said Thijs Spoor, CEO of AzurRx.  “We are developing AZX1103 to prevent hospital acquired infections, such as those caused by Clostridium difficile (C. diff) and vancomycin resistant enterococcus (VRE). The next steps in this program will be to conduct toxicity studies in animals with the goal of receiving the regulatory approvals to enter the clinic.”

The series of preclinical studies investigated oral delivery of AZ1103 using three different capsule formulations: immediate-release, enteric-delivery or colonic-delivery. In all three formulations and at all doses tested, AZ1103 appeared to be well tolerated.  No side effects were observed and the animals showed normal behavior, standard food consumption and body weight gain. There was no evidence of acute toxicity, and no severe immunoallergic reactions were seen at doses of up to 180mg/day. The favorable safety profile is partly the result of AZ1103 not being absorbed by the gut and entering the bloodstream. This property was confirmed by ELISA testing, which did not detect the enzyme in AZ1103 in the animal sera.

Click here to read the full press release.