Phase II Human Trial of ViralClear's Anti-Viral for SARS-CoV-2 Coronavirus Underway at 4 Key Trial Sites
Adult patients hospitalized with COVID-19 are enrolled in Austin, TX, Rochester, MN, Jacksonville, FL, and Scottsdale, AZ
Westport, CT, July 13, 2020 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (Nasdaq: BSGM) ("BioSig" or the "Company") and its subsidiary, ViralClear Pharmaceuticals, Inc., today announced the enrollment of adult patients for its Phase II trial for merimepodib, a broad-spectrum, orally administered antiviral drug candidate for the treatment of COVID-19, at four key trial sites. The trial sites are located in Austin, TX, Rochester, MN, Jacksonville, FL, and Scottsdale, AZ.
Merimepodib is intended to be orally administered and has demonstrated broad-spectrum in-vitro antiviral activity, including strong activity against SARS-CoV-2 in cell cultures.
"Three of our four trial sites where our partners are enrolling patients are in the recognized hot spots of Texas, Arizona, and Florida. The patients in this trial are hospitalized and requiring oxygen; therefore, providing effective treatment is of the utmost importance to all," commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc., the majority shareholder of ViralClear Pharmaceuticals, Inc. "Arizona, Florida, and Texas are unfortunately seeing spikes in COVID-19 cases resulting in hospitals reaching near capacity. We would like to thank our clinical partners for the steady progress with the trial and expect to report the trial data later this summer".
The Phase II randomized, double-blind, placebo-controlled study is designed to enroll adult patients with advanced Coronavirus Disease 2019 (COVID-19). A description of this clinical trial can be accessed via www.clinicaltrials.gov.
Preclinical in vitro laboratory studies performed by the Galveston National Laboratory at The University of Texas Medical Branch demonstrated that merimepodib, provided in combination with remdesivir, showed a reduction in SARS-CoV-2 replication to undetectable levels. Peer-reviewed publication of these findings can be found at F1000 Research: https://f1000research.com/articles/9-361
About BioSig Technologies
BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).
The Company's first product, PURE EP(tm) System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.
About ViralClear Pharmaceuticals and Merimepodib (MMPD)
BioSig's subsidiary, ViralClear Pharmaceuticals, Inc., is seeking to develop a novel pharmaceutical called merimepodib to treat patients with COVID-19. Merimepodib is intended to be orally administered and has demonstrated broad-spectrum in vitro anti-viral activity, including strong activity against SARS-CoV-2 in cell cultures. Merimepodib was previously in development as a treatment for chronic hepatitis C and psoriasis by Vertex Pharmaceuticals Incorporated (Vertex), with 12 clinical trials (7 in phase 1 and 5 in phase 2) with over 400 subjects and patients and an extensive preclinical safety package was completed. A manuscript titled, "The IMPDH inhibitor merimepodib provided in combination with the adenosine analogue remdesivir reduces SARS-CoV-2 replication to undetectable levels in vitro", was submitted to an online peer-reviewed life sciences journal. This manuscript is authored by Natalya Bukreyeva, Rachel A. Sattler, Emily K. Mantlo, John T. Manning, Cheng Huang and Slobodan Paessler of the UTMB Galveston National Laboratory and Dr. Jerome Zeldis of ViralClear Pharmaceuticals, Inc. ("ViralClear") as a corresponding author. This article highlights pre-clinical data generated under contract with Galveston National Laboratory at The University of Texas Medical Branch.
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