Arch Biopartners Inc. Advances Phase II Trial of LSALT Peptide for Kidney Injury Prevention
- Arch Biopartners has received approval for its Phase II trial of the LSALT peptide to prevent AKI during cardiac surgery.
- The trial expands to seven global sites, recruiting 240 patients, with a focus on the Canadian market.
- LSALT peptide targets kidney injury prevention, aiming to establish new standards in perioperative care and nephrology.
Arch Biopartners Advances Phase II Trial of LSALT Peptide to Combat Cardiac Surgery-Associated Kidney Injury
Arch Biopartners Inc. has recently achieved a significant milestone by obtaining approval from the University Health Network (UHN) Research Ethics Board for Toronto General Hospital (TGH) to participate in its ongoing Phase II clinical trial of the LSALT peptide. This trial is specifically designed to prevent acute kidney injury (AKI) associated with cardiac surgery, a common and serious complication affecting up to 30% of patients undergoing procedures such as coronary artery bypass grafting. With TGH now on board, the trial expands to seven global sites, of which TGH is the second in Canada, allowing for the recruitment of 240 patients.
The LSALT peptide is Arch Biopartners' lead candidate targeting the dipeptidase-1 (DPEP1) pathway, which has demonstrated potential in preclinical studies for mitigating ischemia-reperfusion injury to the kidneys. In a multi-center, randomized, double-blind, placebo-controlled format, the study aims to evaluate the incidence of AKI within seven days following on-pump cardiac surgery, adhering to Kidney Disease: Improving Global Outcomes (KDIGO) criteria. The trial's design emphasizes a rigorous scientific approach, as there are currently no available therapeutic options for preventing AKI in this patient demographic, highlighting the urgent need for effective interventions.
CEO Richard Muruve expresses contentment with the approval from UHN and outlines a strategic shift in recruitment focus from Turkey to Canada. This decision aims to enhance data collection efforts and strengthen the study's findings. The escalating incidence of CS-AKI underscores the importance of the LSALT peptide, particularly given the significant morbidity and mortality rates associated with this complication. Arch Biopartners is committed to advancing its pipeline, which includes cilastatin, targeting distinct causes of kidney injury, thereby reinforcing its position in the biopharmaceutical sector focused on innovative kidney therapies.
In addition to the trial approval, Arch Biopartners is poised to make substantial contributions to the field of nephrology. The company’s focus on the DPEP1 pathway represents a forward-thinking approach to addressing unmet medical needs in kidney protection during critical surgical procedures. As the LSALT peptide progresses through clinical evaluation, it could pave the way for new standards in perioperative care.
As Arch Biopartners continues its clinical endeavors, the implications of its research extend beyond the immediate trial outcomes. The potential success of the LSALT peptide could not only enhance patient safety during cardiac surgery but also stimulate further research into kidney injury prevention, positioning Arch as a leader in innovative therapeutic solutions within the biopharmaceutical landscape.