Moleculin Biotech, Inc., a clinical stage pharmaceutical company with a portfolio of drug candidates targeting highly resistant tumors and viruses, has selected IQVIA Biotech, a CRO, to manage the company’s effort to begin potential clinical trials of WP1122 for the treatment of COVID-19.
 
“Our teaming up with IQVIA, a preeminent, global CRO, is intended to facilitate the advancement into possible clinical trials for WP1122 with the objective of determining our drug’s potential for treating COVID-19,” said Walter Klemp, Moleculin’s Chairman and CEO. “We continue to believe the best possible pathway for development may be outside the U.S., given the FDA’s requirement that we complete an analysis in a COVID-19 animal model before submitting a request for US investigational new drug (IND) status. Unfortunately, validated COVID-19 animal models are in high demand, resulting in a long lead time before that can be done. In the meantime, we believe all of the necessary preclinical safety testing has now been completed to qualify for the equivalent of an IND outside the U.S. Over the last quarter, we completed our preclinical data, interviewed CRO’s and decided that IQVIA Biotech has the experience and reach to best serve our clinical needs for this project.”
 
WP1122 is a prodrug of 2-DG, a well-known antimetabolite with the ability to inhibit glycolysis and alter glycosylation, two processes critical to coronaviruses like SARS-CoV-2, the virus responsible for COVID-19.  Although 2-DG has shown activity against SARS-CoV-2, other coronaviruses and other non-coronaviruses, we believe its therapeutic potential is limited by its inherent lack of drug-like properties. WP1122 was designed to improve the drug-like characteristics of 2-DG, specifically, increasing pharmacokinetics.