Arch Biopartners Receives Ethics Committee Approval in Turkey for Phase II Trial for LSALT Peptide
10 Septiembre 2020 - 7:59AM
Arch Biopartners Inc. (“Arch” or the “Company”) (TSX Venture: ARCH
and OTCQB: ACHFF), announced today that it received approval in
Turkey from the Istanbul University Ethics Committee for the Phase
II trial of its lead drug LSALT peptide (Metablok), targeting acute
lung injury and acute kidney injury caused by inflammation in
patients with severe cases of COVID-19.
The Ethics Committee approval of the trial will
be followed by a regulatory review conducted by the Turkish
Ministry of Health (MoH), expected to be completed by
mid-September. Once the trial is approved by the MoH, activation of
clinical sites in Istanbul and Ankara will take place and patient
enrollment into the trial will commence.
Recent data have shown an upswing in new
COVID-19 infections and hospitalizations in Turkey, with over 1,700
new cases reported on September 8th compared with approximately
900-1000 daily new cases during July. There have been 22,000
reported new cases and over 600 related deaths since August
25th.
“We continue to work quickly with our Turkish
partners to expand the LSALT peptide Phase II trial into Turkey. We
look forward to a positive decision from the MoH, which will permit
enrollment of Turkish COVID-19 patients into the trial. At the same
time, we continue to progress on a day-to-day basis to enrol the
first U.S patient into this trial,” said Richard Muruve, CEO of
Arch Biopartners.
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 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.
The Phase II results will be used to design a
Phase III trial, including higher patient numbers and optimal drug
dosing.
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 approved vaccine or
effective antiviral drug exists for SARS-CoV-2. 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.
For more information, please contact:
Richard MuruveChief Executive OfficerArch Biopartners, Inc.
647-428-7031info@archbiopartners.com
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
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