- Health Canada has approved Arch Biopartners (ARCH) protocol amendments for the Phase II trial of its lead drug LSALT peptide
- The drug targets acute lung and kidney injury caused by inflammation in patients with severe cases of COVID-19
- The amendments include lowering the minimum age of admissible patients to 18 years from 45
- The amended protocol has now been distributed to the two clinical sites currently active in Calgary
- Arch Biopartners is up 1.56 per cent on the day, with shares trading at C$1.30 at 11:16 am ET
Health Canada has approved Arch Biopartners (ARCH) protocol amendments for the Phase II trial of its lead drug LSALT peptide.
The drug is meant to target acute lung injury and acute kidney injury caused by inflammation in patients with severe cases of COVID-19.
The company received a No Objection Letter from Health Canada for its amendments.
The amendments include lowering the minimum age of admissible patients to 18 years from 45 and a simplified treatment regimen including the reduction in daily blood draws based on the safety profile observed in prior patients.
The protocol amendments were recommended by clinical investigators and medical advisors and were based on information gathered from the first 45 patients recruited into the Phase II trial.
The changes are designed to “facilitate enrolment and execution of the sixty-patient study, improve patient care for those undergoing treatment and to broaden patient eligibility to receive (the drug),” according to the company.
“We appreciate the rapid review and approval of the protocol amendment by Health Canada. The amended protocol will broaden the patient base and simplify our Phase II trial for Metablok. We look forward to the approval of the amendment by the respective ethic committees to make our trial more patient friendly, less labour intensive and more inclusive for a wider range of patients,” said Arch Biopartners Richard Muruve.
The amended protocol has now been distributed to the two clinical sites currently active in Calgary.
The amended protocol will also be submitted to the U.S. FDA, as well as the Turkish Ministry of Health, with adoption by the participating clinical sites in the USA and Turkey as soon as possible.
Arch Biopartners is up 1.56 per cent on the day, with shares trading at C$1.30 at 11:16 am ET.