FDA Clears the Investigational New Drug Application to Enable the Phase II Trial of ViralClear’s Merimepodib, Oral Solution...
May 18 2020 - 8:32AM
- Phase II clinical trial expected to be conducted at
multiple centers in the United States, including three Mayo Clinic
sites under the leadership of Andrew D. Badley, M.D.,
Enterprise Chair of COVID-19 Task Force
- Randomized, double blind, placebo-controlled clinical
trial to be conducted in adults with COVID-19 who are hospitalized
and either require supplemental oxygen or are on non-invasive
ventilation or high flow oxygen devices
BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the
“Company”) and its majority owned subsidiary, ViralClear
Pharmaceuticals, Inc. (ViralClear), today announced that the U.S.
Food and Drug Administration (FDA) has completed its review of
ViralClear’s Investigational New Drug (IND) application. The FDA
informed ViralClear that it may proceed with a proposed phase II
study of merimepodib oral solution in adults with COVID-19 who are
hospitalized and either require supplemental oxygen or are on
non-invasive ventilation or high flow oxygen devices.
This study will be a randomized, double blind,
placebo-controlled trial to evaluate the efficacy and safety of
merimepodib as an orally administered treatment. The trial will
occur in hospitalized patients who have confirmed infection with
SARS-CoV-2 and require supplemental oxygen.
“I’m very pleased to be involved in this planned
Phase II study of merimepodib for the treatment of patients with
COVID-19 disease,” said Andrew D. Badley, M.D., Professor and Chair
of Department of Molecular Medicine and the Enterprise Chair of
COVID-19 Task Force. “We are grateful to the FDA for their prompt
response in helping accelerate opportunities to find treatments for
the novel coronavirus. We plan to begin enrollment of this trial as
soon as practicable given the importance of finding solutions to
this pandemic.”
“FDA clearance for our proposed phase II trial
to proceed is an important step for the development of
merimepodib,” commented Jerome B. Zeldis, M.D., Ph.D, Executive
Chair, co-founder and acting Chief Medical Officer of ViralClear
Pharmaceuticals, Inc. “We intend to conduct Phase II evaluations of
our drug both in the hospital and outpatient settings as part of
our clinical development plan.”
“We thank the Mayo Clinic for collaborating with
us to conduct the trials under the leadership of Professor Badley,”
said Nick Spring, Chief Executive Officer of ViralClear
Pharmaceuticals, Inc. “Of the therapies that are currently being
evaluated as treatments and can be available in the short term, we
believe that a broad-spectrum antiviral that is orally administered
and widely available could be very helpful in addressing the
COVID-19 pandemic. We further believe it can play a pivotal role in
helping manage this type of public health crisis.”
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 Merimepodib (MMPD) Merimepodib, a
broad-spectrum anti-viral candidate, that demonstrates strong
activity against COVID-19 in cell cultures in laboratory testing
and additional antiviral studies are underway. Merimepodib
was previously in development as a treatment for chronic hepatitis
C and psoriasis by Vertex Pharmaceuticals Incorporated (Vertex),
with 12 clinical trials conducted (including 315 chronic hepatitis
C patients, 24 psoriasis patients, and 98 healthy volunteers) and
an extensive preclinical safety package 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.
About ViralClearBioSig’s subsidiary ViralClear
Pharmaceuticals, Inc., is seeking to develop a novel pharmaceutical
to treat COVID-19. Merimepodib is intended to be orally
administered, and has demonstrated broad-spectrum in vitro
antiviral activity, including strong activity against COVID-19 in
cell cultures. Merimepodib has been previously studied in 12
clinical trials, including 5 in patients with hepatitis C (1 Phase
1b, 1 Phase 2, 2 Phase 2a, and 1 Phase 2b), 1 in patients with
psoriasis (Phase 2), and six in healthy volunteers (Phase
I).
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
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