Moleculin Biotech Inc., a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, has entered into an agreement with Sterling Pharma USA LLC for U.S. production of WP1122 to support its expanded development efforts in preparation for submitting a request to the FDA for Investigational New Drug (IND) status for WP1122 for the potential treatment of COVID-19.
 
“In light of the added complexity surrounding drug production during the current COVID-19 pandemic, we wanted to make sure we had a reliable source of drug supply located here in the U.S.,” commented Walter Klemp, chairman and CEO of Moleculin. “We are expanding our planned preclinical studies for the IND, including testing multiple analogs of WP1122 against various viruses in vitro, and potentially, in vivo. The latter will be difficult to time due to the current high demand for in vivo testing for the treatment of COVID-19. Our contract with Sterling Pharma Solutions should help provide us with sufficient product to support this increased use in combination with our expected clinical trials.”
 
The planned tests are intended to provide additional comparative data of WP1122 and its close analogs. Additionally, the results of in vitro testing thus far led the company to believe that conventional methods of antiviral testing may not be ideally suited to test the class of agents represented by 2-DG and WP1122 and testing methods may need to be optimized to reflect the full antiviral potential of these sugar antimetabolites.
 
Management believes the mechanism of action of 2-DG and WP1122 is very different from other drugs being developed for COVID-19.  Specifically, because 2-DG has been shown to target glucose metabolism and the process of glycosylation, in vitro testing results are significantly affected by the concentration of natural glucose in the microenvironment present during viral replication and continued infection.  Therefore, the company will seek to evaluate WP1122 in an animal model for COVID-19 as a part of its IND preparation.
 
“It’s also worth remembering that an additional benefit of the IND-enabling work we are doing for WP1122 for the possible treatment of patients with COVID-19 is that this also supports the necessary work for an IND for WP1122 for the potential treatment of patients with other viral infections or certain cancers,” Klemp added.