VA San Diego Healthcare System Joins the Phase II Trial of LSALT Peptide for the Treatment of Complications in Hospitalized C...
10 Diciembre 2020 - 6:27AM
Arch Biopartners Inc. (“Arch” or the “Company”) (TSX Venture: ARCH
and OTCQB: ACHFF), announced today that the Veterans Affairs San
Diego Healthcare System (VASDHS) has started recruiting patients
for the Phase II trial of its lead drug LSALT peptide, targeting
the prevention of acute lung injury, acute kidney injury and other
complications caused by inflammation in hospitalized patients with
moderate to severe cases of COVID-19.
“Acute lung injury and acute kidney injury are
among the most serious consequences of COVID-19, and novel
medications focused on preventing these organ failures have the
potential to be life-saving. We are excited to be part of this
research, and to give our Veterans the opportunity to participate
in this trial,” said Dr. Mark Hepokoski, M.D. a pulmonary and
critical care physician at the VASDHS and site principal
investigator for the LSALT Phase II trial.
The VASDHS is the fifth hospital to be activated
into the trial, joining sites in Florida and Louisiana, as well as
two hospital sites in Turkey. Arch is currently exploring
opportunities to add Canadian clinical sites into the trial as the
number of hospitalized COVID-19 patients has grown significantly in
Alberta and Ontario in recent weeks.
Hospitalizations of COVID-19 patients have been
on the increase as infection rates have surged throughout the
world. In the last month, California has experienced a spike in
COVID-19 infection rates, with daily cases growing from
approximately 3,000 cases in early October to over 25,000 daily
cases. Infection rates in the U.S. are now at the highest level of
the year, with over 200,000 daily cases reported this past week.
COVID-19 infection rates in Turkey have similarly spiked to 30,000
daily cases, more than ten times the average daily numbers reported
there in July.
About the Phase II trial for
LSALT Peptide
The Phase II trial is an international,
multicenter, randomized, double-blind, placebo-controlled, proof of
concept study of LSALT peptide (Metablok) as prevention of organ
inflammation known to trigger acute respiratory distress syndrome
(ARDS) and acute kidney injury (AKI) in patients infected with
SARS-CoV-2 (COVID-19).
The composite primary endpoint of the Phase II
trial reflects the severe effects often experienced by hospitalized
COVID-19 patients and deemed appropriate for LSALT peptide’s novel
mechanism of action in blocking consequential inflammation in the
lungs and kidneys.
Additional information about the Phase II trial
can be found at:
https://clinicaltrials.gov/ct2/show/NCT04402957
The Phase II results will be used to design the
Phase III trial, including greater patient numbers to more fully
evaluate efficacy and safety in COVID-19 patients.
About
COVID-19
COVID-19 is the disease caused by the novel
coronavirus SARS-CoV-2 that emerged in China in late 2019. Severe
complications from COVID-19 are in large part due to excessive host
immune responses to the virus that result in progressive lung
inflammation and acute respiratory distress syndrome that often
requires mechanical ventilation and critical care1. Patients with
severe COVID-19 also experience multiple organ dysfunction
including acute kidney injury, liver dysfunction, cardiac failure,
and blood abnormalities. Currently, no effective antiviral drug or
specific treatment exists for SARS-CoV-2 infection. Treatment of
severe COVID-19 has been primarily supportive, relying heavily on
respiratory, infectious disease and critical care medicine.
Survival rates and health care system capacity
could both be improved with new treatments that prevent the severe
manifestations of COVID-19, such as worsening lung inflammation
(ARDS) and AKI experienced by patients infected with
SARS-CoV-2.
1 J. S. Ayres, Sci. Adv 10.1126/sciadv.abc1518 (2020)
About Arch Biopartners
Arch Biopartners Inc. is a clinical stage
company focused on the development of innovative technologies that
have the potential to make a significant medical or commercial
impact. Arch is developing a pipeline of new drug
candidates that inhibit inflammation in the lungs, liver and
kidneys via the dipeptidase-1 (DPEP-1) pathway for multiple medical
indications.
For more information on Arch Biopartners, its
technologies and other public documents Arch has filed on SEDAR,
please visit www.archbiopartners.com
The Company has 60,782,302 common shares
outstanding.
Forward-Looking Statements
All statements, other than statements of
historical fact, in this news release are forward looking
statements that involve various risks and uncertainties, including,
without limitation, statements regarding the future plans and
objectives of the Company. There can be no assurance that such
statements will prove to be accurate. Actual results and future
events could differ materially from those anticipated in such
statements. These and all subsequent written and oral
forward-looking statements are based on the estimates and opinions
of management on the dates they are made and are expressly
qualified in their entirety by this notice. The Company assumes no
obligation to update forward-looking statements should
circumstances or management’s estimates or opinions change.
The science and medical contents of this release
have been approved by the Company’s Chief Science Officer
The Company is not making any express or implied
claims that its product has the ability to eliminate, cure or
contain Covid-19 (or SARS-2 Coronavirus) at this time
Neither TSX Venture Exchange nor its Regulation
Services Provider (as that term is defined in the policies of the
TSX Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release
For more information, please contact:
Richard Muruve
Chief Executive Officer
Arch Biopartners, Inc.
647-428-7031
info@archbiopartners.com
Arch Biopartners (TSXV:ARCH)
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