ViralClear Opens Enrollment with First Patient Dosing in Phase II Human Trial of Anti-Viral MMPD Oral Solution for Treatment of COVID-19

Rhea-AI Summary

BioSig Technologies (Nasdaq: BSGM) announced the commencement of patient enrollment in its Phase II trial for merimepodib, an oral antiviral treatment for COVID-19. The trial includes sites from the Mayo Clinic and Atlantic Health System. Merimepodib has shown effectiveness in reducing SARS-CoV-2 replication in preclinical studies. Previously developed for hepatitis C, it has undergone 12 clinical trials with over 400 patients. The company cites potential risks in its forward-looking statements regarding operations, competition, and regulatory approvals.

Positive

• Commencement of Phase II trial for merimepodib with first patient enrolled.
• Merimepodib showed in vitro efficacy against SARS-CoV-2, reducing replication to undetectable levels.
• Prior extensive clinical development history with over 400 patients in 12 trials.

Negative

• Risks associated with COVID-19 impacting business operations.
• Potential difficulties in securing regulatory approvals for products.
• Challenges in scaling up manufacturing and obtaining financing.

Westport, CT, June 17, 2020 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”) and its subsidiary, ViralClear Pharmaceuticals, Inc., today announced that it has commenced patient enrollment with the dosing of the first patient in its Phase II trial for merimepodib, a broad-spectrum, orally administered anti-viral drug candidate for the treatment of COVID-19 in adult patients. Confirmed trial sites include 3 sites from the Mayo Clinic including Rochester, MN, Jacksonville, FL, Phoenix, AZ and St. David’s South Austin Medical Center in Austin, TX and the Atlantic Health System -Overlook Hospital in Summit, NJ and Morristown Medical Center in Morristown, NJ.

The Phase II trial is titled  “A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Oral Merimepodib in Combination with Intravenous Remdesivir in 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 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 antiviral 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.

Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Andrew Ballou
BioSig Technologies, Inc. 
Vice President, Investor Relations 
54 Wilton Road, 2nd floor
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133

FAQ

What is the latest update on BioSig Technologies' COVID-19 trial?

BioSig Technologies has initiated patient enrollment in a Phase II trial for its antiviral drug, merimepodib, aimed at treating COVID-19.

What are the key trial sites for BioSig's Phase II study?

The trial will take place at several locations, including the Mayo Clinic sites in Rochester, Jacksonville, Phoenix, and St. David’s South Austin Medical Center.

What were the results of merimepodib in preclinical studies?

In preclinical tests, merimepodib reduced SARS-CoV-2 replication to undetectable levels when combined with remdesivir.

How many patients were involved in the prior clinical trials for merimepodib?

Merimepodib has a history of 12 clinical trials involving over 400 patients.

What risks does BioSig Technologies mention in the press release?

The company highlights potential risks related to COVID-19's impact on business, manufacturing challenges, financing issues, and regulatory approval hurdles.