Arch Biopartners’ Lead Drug LSALT Peptide to Enter the Canadian Treatments for COVID-19 (CATCO) Trial

Arch Biopartners Inc. recently announced its lead drug candidate, LSALT Peptide (LSALT and Metablok) will enter the Canadian Treatments for COVID-19 (CATCO) human trial, a multi-centre adaptive, randomized, open-label, controlled study being conducted in sixty-five hospitals across Canada, in conjunction with the World Health Organization’s (WHO) SOLIDARITY trial, in collaboration with countries around the world and with support from the Canadian Institutes of Health Research (CIHR)-funded Canadian Network of COVID-19 Clinical Trials Networks. LSALT will be evaluated in the Canadian trial.

Based on results of the Phase 2 study completed earlier this year, the primary endpoint of the confirmatory clinical trial will be the difference in the number of respiratory support free days between study groups during the 28-day study period. The control group will receive standard of care and the drug group will receive standard of care plus LSALT. Based on the Phase II results, a total of 320 patients will be required in each study group to detect an unadjusted treatment difference of 3.35 days requiring ventilation with 90% power.

Secondary endpoints include mortality, differences in outcomes involving other organs affected by COVID-19, such as kidney, liver, and heart function, time of hospitalization and intensive care stay, healthcare resource utilization, and late follow-up at 12 months post hospitalization.

Sunnybrook Research Institute (SRI) is the sponsor of the CATCO trial. SRI has entered into a collaboration agreement with Arch Biopartners to use LSALT in a new arm of the CATCO trial. SRI and CATCO leadership will now seek ethics committee and Health Canada approvals before commencing the dosing of LSALT in the CATCO trial.

The company’s responsibilities during the trial include supplying LSALT drug vials to support the trial until completion. Arch completed the manufacturing of a new supply of vials during the summer and autumn of this year and has enough drug supply on hand for the 320 patients scheduled to be dosed in the CATCO trial.

LSALT is entering the CATCO trial on the basis of a positive clinical effect observed in a Phase 2 trial completed earlier this year and funded in part by Innovation Science and Economic Development (ISED) Canada’s Strategic Innovation Fund (SIF), which is part of the Canadian Government’s Plan to Mobilize Science to Fight COVID-19.

The Phase 2 trial was an international, multicenter, randomized, double-blind, placebo-controlled, proof of concept study of LSALT for the prevention of organ inflammation such as acute respiratory distress syndrome (ARDS) and acute kidney injury (AKI) in patients infected with SARS-CoV-2 (COVID-19). Six clinical sites located in Canada, US, and Turkey participated in the Phase 2 trial.

Sixty-one patients were enrolled in the study and randomized 1:1 to receive LSALT or placebo. Despite having older patients and having greater co-morbidities in the LSALT group, the unadjusted analysis of all patients in the trial demonstrated 22.8 ventilation-free days for the LSALT group compared to 20.9 days in the placebo group during the 28-day evaluation period. “Ventilation” was defined as a need for high flow oxygen therapy (≥ 6L/min), non-invasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Adjusting for age, body mass index (BMI), and PaO2/FiO2 ratio (a measure of lung disease severity), the difference in ventilation-free days was 6.7 days favoring the LSALT group vs. placebo.

There were no unexpected differences in adverse events between LSALT and placebo treated patients. LSALT was well tolerated with no safety issues related to the drug. The exploratory study was designed to detect a clinical signal of efficacy and was not powered for statistical significance. Based on the promising clinical signal observed in the patients who received LSALT in the Phase 2 trial, 320 patients are scheduled to be dosed in the CATCO trial in order to detect a statistically significant difference. Full details of the Phase 2 study are currently under consideration at a peer-reviewed scientific journal and will be released as soon as they are published.

These Phase 2 results provide key human data which, in conjunction with extensive preclinical studies, further support DPEP-1 as a relevant therapeutic target for diseases of the lung, liver and kidney where inflammation plays a major role. In addition to evaluating LSALT as a treatment of inflammation complications experienced by hospitalized COVID-19 patients, Arch Biopartners intends to pursue its strategy to develop new DPEP-1 targeting drugs and clinical indications outside of COVID-19.

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, relevant for multiple medical indications. For more information, visit www.archbiopartners.com.