Moleculin Engages IQVIA to Manage Potential COVID-19 Clinical Trial : vimarsana.com

Moleculin Engages IQVIA to Manage Potential COVID-19 Clinical Trial


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HOUSTON, April 6, 2021 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced the engagement of IQVIA Biotech, a contract research organization (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," commented Walter Klemp, Moleculin's Chairman and CEO. "We continue to believe the best possible pathway for development may be outside the US, 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 US. Over the last quarter, we completed our pre-clinical data, interviewed CRO's and decided that IQVIA Biotech has the experience and reach to best serve our clinical needs for this project. In addition, considering that the active ingredient in WP1122 is 2-deoxy-D-glucose (2-DG) and that 2-DG has now shown efficacy in a Phase 2 clinical trial conducted by an unrelated drug developer outside of the US, we believe that a sufficient efficacy rationale for WP1122 already exists to begin clinical trials."

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