ViralClear Expands Ongoing Phase 2 Trial Size for its Oral Anti-Viral for the Treatment of COVID-19, Expands Trial Locations ...
September 22 2020 - 10:55AM
- Size of ongoing Phase 2 trial of merimepodib in
combination with remdesivir increased from 40 to 80 subjects, with
focus on hospitalized patients requiring non-invasive
ventilation/high flow oxygen devices
- Added 2 new Principal Investigators for the ongoing
Phase 2 trial expanding the total number of locations to
10
- Contract Manufacturing Organization (CMO) appointed to
manufacture Phase 3 supplies of merimepodib oral
solution
- Merimepodib monotherapy trial to be conducted in the
outpatient setting after current combination trial
completes
BioSig Technologies, Inc. (Nasdaq: BSGM)
(“BioSig” or the “Company”) and its majority owned subsidiary,
ViralClear Pharmaceuticals, Inc. (ViralClear), today
conducted an investor update call on Viral Clear’s merimepodib drug
development program for the treatment of COVID-19.
The size of the ongoing randomized,
double-blind, placebo-controlled Phase 2 trial of merimepodib in
combination with remdesivir is being increased from 40 to 80
subjects. When the trial was first initiated, it was thought
that COVID-19 patients with National Institute of Allergy and
Infectious Disease (NIAID) 8-point ordinal scores of 3 and 4 (i.e.,
hospitalized patients who require non-invasive ventilation and
patients who require high flow oxygen devices and supplemental
oxygen, respectively) would have similar outcomes in terms of their
disease. However, based on a review of blinded data from the
ongoing trial, subjects with scores of 3 and 4 are showing distinct
differences. All subjects who were admitted with a score of 4
have had an uneventful course of disease and were rapidly
discharged from the hospital due to improvement in clinical
condition. The subjects who were admitted with a score of 3
fared differently: one group of subjects improved and were
discharged from the hospital and are doing well at long-term
follow-up, while others have not improved.
Based on the above and the small numbers of
subjects in each NIAID group, ViralClear decided to increase the
enrollment in the current study to 80 subjects, with a focus on
subjects with an NIAID score of 3 at entry. The decision to
increase the subject number in the trial was also based on advice
from industry experts and discussions with government agencies and
non-governmental organizations. Once additional subjects are
enrolled and further clinical data is obtained, the team will
discuss with the FDA the appropriate size for a Phase 3
trial.
Two additional Principal Investigators were
added to the ongoing Phase 2 trial to improve the enrollment rate,
increasing the total number of locations to 10.
ViralClear has contracted with a US-based
Contract Manufacturing Organization (CMO) to manufacture the
registration stability batches [required for the New Drug
Application (NDA) filing] of the merimepodib oral solutions (drug
product) that will also serve as clinical trial supplies for the
Phase 3 trial. In July 2020, Viralclear previously announced
an agreement with another US-based CMO, AMRI, to produce the
registration stability batches of the merimepodib (active
pharmaceutical ingredient).
The merimepodib monotherapy trial to be
conducted in the outpatient setting will be initiated after the
completion of the current Phase 2 combination trial. The
Emergency Use Authorizations (EUAs) for remdesivir and convalescent
plasma, as well as the increasing use of dexamethasone as a
standard of care in hospitalized COVID-19 patients, has precluded
an evaluation of merimepodib monotherapy in this setting (i.e.,
hospitalized patients).
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 and ViralClear
BioSig’s Technologies, Inc (Nasdaq: BSGM) subsidiary,
ViralClear Pharmaceuticals, Inc. (ViralClear), 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 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
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