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Moleculin Biotech, Inc announced that it has received notification from Nasdaq that trading in the company's common stock will resume on Thursday, May 28, 2020.

In order to properly support the company's planned IND application, it has engaged ImQuest BioSciences and the Illinois Institute of Technology Research Institute, two organizations focused on supplying the kind of contract research support required for an IND submission. While IITRI is initially focused on preclinical toxicology testing to help determine whether WP1122 can be considered safe for testing in humans, ImQuest is focused on supporting the scientific rationale behind proposing WP1122 as a possible treatment for COVID-19. On April 7, Moleculin contracted with ImQuest for two rounds of preclinical assessment of the potential for WP1122 to address COVID-19. The first step was to demonstrate whether or not the improved pharmacology of WP1122 gave it a greater therapeutic window than 2-DG, a compound which was shown to stop replication of SARS-CoV-2 by an independent research team at the Goethe-University of Frankfurt in a preprint of a research article and also was previously shown to display antiviral activities in other viruses. This first ImQuest step was done with a cell viability assay comparing inhibition of virus-induced cytopathic effects of 2-DG and WP1122 head-to-head in a human cell line infected with a coronavirus. The second round was to demonstrate the ability of WP1122 to inhibit coronavirus production in mammalian cell culture. This was done using a virus yield reduction assay. The testing done by ImQuest was performed on a surrogate of SARS-CoV-2 called Human coronavirus strain 229E because it was a validated assay immediately available at ImQuest. Moleculin's scientific team and ImQuest consider HCoV-229E to be an appropriate model for SARS-CoV-2 in particular because one of the primary theoretical mechanisms of action for both 2-DG and WP1122 is alteration of the glycoprotein/glycan structures (spikes) that form on the outside shielding of the virus, and the glycoprotein/glycan spikes present on HCoV-229E play a similar function in the viral lifecycle to those on SARS-CoV-2. As well, the other primary MOA of 2-DG/WP1122 is the inhibition of glycolysis and the HCoV-229E surrogate has a similar dependence on glucose/mannose metabolism. Although these in vitro results should not be considered conclusive or indicative of what will happen in vivo, the initial results received on May 4, 2020 show that both 2-DG and WP1122 have an antiviral effect on HCoV-229E. WP1122 displayed a greater therapeutic index than 2-DG, while the virus yield reduction assay demonstrated a 5 to 10-fold inhibition of coronavirus production by WP1122 and 2-DG when compared to untreated virus control. Out of an abundance of caution, the company requested ImQuest repeat their tests to provide additional confidence in their findings, and, as such, the company cautions readers not to rely on these initial results. In addition to having ImQuest repeat their tests, the company is arranging for additional in vitro testing to include additional human cell lines and the use of a validated SARS-CoV-2 assay, as well as testing against other pathogenic viruses, all with the intent of increasing the strength of the basic scientific rationale.

Moleculin Biotech announced that the U.S. FDA has granted the company's request for a Pre-IND Meeting to provide guidance regarding the company's plan to study its drug candidate, WP1122, in a clinical trial for patients with COVID-19. In addition, Moleculin provided a general update on its WP1122 development efforts. The company said, "We estimate that we should be able to submit our IND application in the second half of this year. More specific timing will depend upon the guidance we receive from our Pre-IND Meeting with the FDA."