Health Canada has granted approval to amend the Canadian Treatments for COVID-19 (CATCO) trial protocol to incorporate Arch Biopartners’ lead drug candidate, LSALT Peptide (LSALT and Metablok), in a new dosing arm.
A No Objection Letter was issued by the Canadian regulatory authority to the trial team for the Clinical Trial Application – Amendment.
LSALT is a new drug candidate that acts on the acute organ inflammation in the lungs, liver and kidneys associated with various indications, including moderate to severe Covid-19 cases, irrespective of the variant.
The company noted that the dosing of subjects with LSALT peptide is anticipated to commence after obtaining final domestic approval and preparing the study site.
Being carried out at up to 55 hospitals in Canada, the multicentre, randomised, adaptive, controlled, open-label trial will identify new therapies for Covid-19 associated complications in patients.
Funded by the Canadian Institutes of Health Research, the trial is supported by the Canadian Network of COVID-19 Clinical Trials Networks.
Furthermore, Sunnybrook Research Institute (SRI) is serving as the trial sponsor and manages CATCO across all study centres in the country.
SRI and Arch Biopartners signed a partnership agreement under which the former can use LSALT in a new trial arm.
Arch Biopartners will deliver LSALT drug vials needed for dosing up to 350 subjects in the trial.
In January, the company obtained approval from the Research Ethics Board at the SRI to amend the trial protocol to include LSALT in a new arm of the CATCO.
Focused on developing novel technologies, Arch Biopartners has a pipeline of new drug candidates that hinder lung, liver and kidney inflammation through the dipeptidase-1 (DPEP-1) pathway.
In March 2021, Arch Biopartners obtained approval to make some amendments to the protocol of the Phase II trial analysing LSALT peptide.