Avalo Therapeutics AVTX has dosed the first patient in the pivotal LADDER trial to assess the efficacy and safety of AVTX-803 in Subjects with Leukocyte Adhesion Deficiency Type II (LAD II) ER).
AVTX-803 is developed and studied for the treatment of leukocyte adhesion deficiency type II (LAD II, also known as SLC35C1-CDG).
The LADDER trial is a pivotal withdrawal study to assess the efficacy and safety of AVTX-803 in patients with LAD II (n=2).
The primary endpoint is the comparison of leukocyte function as determined by sialyl Lewis-X (SLx) antigen expression on leukocytes between treatment periods.
Garry A. Neil, MD, President and Chief Executive Officer, commented: "We are excited to announce the first patient was dosed in the LADDER pivotal trial. This substantially advances the program toward an approved treatment option for patients and also a potential PRV.”
Previously, FDA has granted AVTX-803, a Rare Pediatric Disease Designation (RPDD), Orphan Drug Designation (ODD) and Fast Track Designation (FTD).
Price Action : Avalo shares are trading around 13 percent at $4.05 on Tuesday during pre-market session.
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