Moleculin Biotech, Inc., (Nasdaq: MBRX) stock price is going significantly up in pre-market trading session. The reason behind this sudden surge is an announcement issued thos morning. According to Moleculin, a repeat of previous in vitro testing has corroborated the antiviral potential of WP1122.
Although developing in vitro data is an initial step and the data may not necessarily reflect the antiviral effects in vivo, the results of this repeated round of in vitro testing received on June 1, 2020, confirm that WP1122 has an antiviral effect on Human Coronavirus 229E (“HCoV-229E”), a surrogate of SARS-CoV-2, the virus responsible for COVID-19.
“We felt it was important to confirm these results,” commented Walter Klemp, Chairman and CEO of Moleculin, “so, out of an abundance of caution, we had an independent testing contractor run them a second time. While the results are encouraging, we believe, based on guidance from the FDA, we will need additional studies to further assess WP1122’s antiviral capability, and consistent with our previous guidance, we will continue to push forward with additional in vitro and in vivo testing with the goal of a possible IND filing by the end of 2020, in preparation for beginning a human clinical trial thereafter.”
The guidance provided thus far by MBRX has been that it expects to file its request for Investigational New Drug (IND) status to test WP1122 for the treatment of COVID-19 patients during the second half of 2020.
The opportunity to shorten that time frame may depend on the Company’s ability to use non-GLP (studies not done in strict adherence to “Good Laboratory Practices”) toxicology data for the IND submission and exploring this possibility was a part of the Company’s request for feedback in its Pre-IND submission to the US Food and Drug Administration, (“FDA”).
What is next for Moleculin?
Based on the FDA’s response, Moleculin now plans to present its non-GLP toxicology, when available, to the FDA in a second Pre-IND meeting request. While there can be no assurance that the FDA will allow Moleculin’s IND to go into effect on the basis of non-GLP toxicology data, the Company believes the possibility is worth pursuing, because it could significantly reduce its timeline to begin clinical trials for WP1122.
On May 27, 2020, Moleculin announced results from the initial preclinical assessment of the potential for WP1122 to address COVID-19. The testing involved a cell viability assay,