ViralClear halts its Phase 2 Hospitalized COVID-19 Trial
26 October 2020 - 10:30PM
BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the
“Company”) and its majority owned subsidiary, ViralClear
Pharmaceuticals, Inc. (ViralClear), announced the halting of its
signal finding Phase 2 trial, “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)”.
After the implementation of a protocol amendment
that expanded the size of the trial from 40 to 80 hospitalized
COVID-19 patients, and that limited enrollment to seriously ill
patients, (NIAID Grade 3, who required high flow, high
concentration oxygen to maintain adequate oxygenation) the Safety
Monitoring Committee (SMC) was unblinded for safety reasons since
these patients are at higher risk for dying from their disease. At
the time of the most recent review of the data by the SMC, 44
patients had been enrolled in the trial of whom 42 had received
study drug (either merimepodib solution or matching placebo). This
most recent review of the data documented all 22 Grade 4 patients
were discharged from the hospital and did not relapse during the 37
day follow-up period. However, patients who were NIAID Grade
3 patients (n = 20) at the time of enrollment had markedly
different outcomes. Specifically, the unblinded SMC detected an
imbalance in survival rates in these NIAID Grade 3 patients between
the placebo and merimepodib making it unlikely that the trial would
meet its primary safety endpoints. The company has therefore
elected to stop enrollment into the clinical trial. Patients will
be followed as per the protocol for safety monitoring; however, no
further study drug treatments will be administered.
At this time, the Company does not intend to
further develop merimepodib. However, the Company will see if other
parties are interested in acquiring or licensing merimepodib.
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.
Forward-looking StatementsThis 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
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