Arch Biopartners Announces Dosing of First Patient in Turkey in Phase II Trial of LSALT peptide to Treat Complications from Covid-19

TORONTO, Nov. 05, 2020 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that patient dosing in Turkey has begun in the Phase II trial of its lead drug LSALT peptide, targeting 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.

The first patient was dosed in Istanbul yesterday and patient recruitment at the Istanbul site is now ongoing. Additional patients are expected to be enrolled this week at a second clinical site in Ankara, the nation’s capital.

In recent weeks, COVID-19 infection rates in Turkey have worsened to over 2,000 official cases per day, up from an average of approximately 900 daily cases in July.  Since the second wave of Covid-19 infection emerged in Turkey in late summer, new COVID-19 hospitalizations continue to strain the Turkish medical system and there have been over 10,000 deaths so far in 2020. 

The Phase II trial continues to recruit patients in two hospital sites in the U.S. (in Florida and Louisiana) while the Company is exploring the opportunity to add Canadian clinical sites to the trial.

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). Patient enrollment is initially planned to be 60 patients.

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 the Phase III trial, including greater patient numbers to more fully evaluate efficacy and safety in COVID 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 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.