Moleculin Engages IQVIA to Manage Potential COVID-19 Clinical Trial
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 ofIQVIA, 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."
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 circulation time and tissue and organ uptake and concentration (often referred to as improved "pharmacokinetics"). Moleculin has sponsored multiple in vitro analyses showing activity of WP1122 against coronaviruses superior to that of 2-DG alone, as well as preclinical animal tumor models (WP1122 was originally developed as a potential cancer drug) showing the improved pharmacokinetics of WP1122.
For additional information on WP1122 and its potential to treat both viruses and cancers, please visit http://www.moleculin.com.
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors and viruses. The Company's clinical stage drugs are: Annamycin, a Next Generation Anthracycline, designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic cancer and hematologic malignancies, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin is also engaged in preclinical development of additional drug candidates, including other Immune/Transcription Modulators, as well as WP1122 and related compounds capable of Metabolism/Glycosylation Inhibition.
For more information about the Company, please visit http://www.moleculin.com.
IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analysing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA's insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviour and scientific advances, in an effort to advance their path toward cures. To learn more, visit www.iqvia.com.
Contact: James Salierno, firstname.lastname@example.org
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SOURCE Moleculin Biotech, Inc.
Company Codes: NASDAQ-SMALL:MBRX, NYSE:IQV