- Turkish Ministry of Health approves increase in patient recruitment into the Phase II trial for LSALT Peptide
- The approval from the MoH doubles the number of patients allowed from twenty to forty
- Patient recruitment is expected to resume this week in two hospital sites in Istanbul and Ankara
- Arch Biopartners Inc. is a clinical-stage company focused on the development of innovative technologies
- Arch Biopartners Inc. (ARCH) is down 1.56 per cent and is trading at C$1.26 at 12:05 pm ET
Arch Biopartners Inc. (ARCH) has received approval to recruit up to twenty additional patients into the Phase II trial of LSALT peptide (Metablok).
This study targets acute lung injury and acute kidney injury caused by inflammation in patients with severe cases of COVID-19.
The approval from the MoH doubles the number of patients allowed into the Turkish arm of the trial from twenty to forty.
The first twenty patients recruited into the trial have completed treatment.
Patient recruitment is expected to resume this week in two hospital sites in Istanbul and Ankara.
Recent data have shown a second surge in new COVID-19 infections and hospitalizations in Turkey, with a new pandemic high of over 32,000 daily infections reported on March 29, 2021.
Turkey experienced a similar surge in daily infections during December 2020. Hospitalization rates are currently at approximately 1 per cent of infected cases, once again putting a strain on the Turkish hospital system.
Patient recruitment in this 60-patient phase II trial continues in four clinical sites in Canada and the USA, with 46 patients recruited to date between North America and Turkey.
“We appreciate the support of the Turkish Ministry of Health and the enthusiasm of our clinical sites in Turkey to recruit more patients into our trial during this difficult pandemic,” said Richard Muruve, CEO of Arch.
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).
AKI has been observed in approximately 35 per cent of patients admitted to hospital with COVID-19 and is also a leading cause of mortality.
The Phase II trial’s composite primary endpoint 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, kidneys, and other organs.
The Phase II results will be used to design the Phase III program, including greater patient numbers to more fully evaluate efficacy and safety in hospitalized patients at risk of inflammation in the lungs, kidneys or liver.
Arch Biopartners Inc. is a clinical-stage company focused on developing innovative technologies that can 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.
Arch Biopartners Inc. (ARCH) is down 1.56 per cent and is trading at C$1.26 at 12:05 pm ET.