The Food and Drug Administration (FDA) has granted Fast Track designation to WP1122 for the treatment of glioblastoma multiforme.
WP1122 is a prodrug of 2-deoxy-D-glucose, or 2-DG, designed to target glycolysis and glycosylation limiting viral infectivity and replication. According to preclinical studies, WP1122 has shown to increase cellular uptake of 2-DG, increase drug half-life, and increase the ability to cross the blood brain barrier leading to higher uptake in the brain.
Additionally, the Company noted that preclinical studies in mice transplanted with human brain tumors have shown WP1122 to outperform the standard of care, temozolomide, and perform better in combination with temozolomide.
Following FDA clearance of its Investigational New Drug (IND) application, the Company expects to initiate a phase 1 study evaluating oral WP1122 in adults with glioblastoma multiforme.
“We believe receiving Fast Track designation validates the serious unmet medical need for the treatment of GBM, the most aggressive form of malignant primary brain cancer,” commented Walter Klemp, Chairman and CEO of Moleculin. “We believe that based on the promising animal model data that supports GBM as one of many potential indications, the clearance of our IND for WP1122 in GBM, and Orphan Drug Designation previously received from the FDA, WP1122 is well-positioned to be a potential treatment option for this devastating disease.”
Moleculin granted FDA Fast Track designation of WP1122 for the treatment of Glioblastoma Multiforme. News release. Moleculin. Accessed December 7, 2022. https://prnmedia.prnewswire.com/news-releases/moleculin-granted-fda-fast-track-designation-of-wp1122-for-the-treatment-of-glioblastoma-multiforme-301696538.html.