Unity Health Toronto

Arch Biopartners Advances AKI Programs: LSALT Peptide and Cilastatin Trials Progress

4 months ago

• Arch Biopartners' Phase II trial of LSALT peptide for cardiac surgery-associated acute kidney injury (CS-AKI) gains ethics approval in Ontario, with patient recruitment set to begin in Toronto. • A 700-patient Phase II trial (PONTiAK) evaluating cilastatin for preventing drug-induced AKI receives a No Objection Letter from Health Canada, paving the way for the trial to proceed. • Both LSALT peptide and cilastatin target the dipeptidase-1 (DPEP1) pathway, addressing significant unmet needs in preventing and treating AKI caused by inflammation or toxins. • These advancements highlight Arch Biopartners' commitment to developing innovative therapies for acute kidney injury and organ damage, with ongoing trials in Canada and internationally.

MedMira's Reveal G4 Rapid HIV-1/2 Test Approved by Health Canada for Point-of-Care Use

5 months ago

• MedMira's Reveal G4 Rapid HIV-1/2 Test receives Health Canada approval for point-of-care use, offering fast and reliable results. • The Reveal HIV test boasts a sensitivity of 99.64% and a specificity of 99.71%, suitable for various healthcare settings. • This rapid test accurately detects HIV-1/2 antibodies from a finger prick sample in under a minute, with no special storage needed. • Approval follows a surge in new HIV diagnoses in Canada, highlighting the need for accessible and efficient testing solutions.

Tolebrutinib Receives FDA Breakthrough Therapy Designation for Non-Relapsing Secondary Progressive Multiple Sclerosis

5 months ago

• The FDA has granted Breakthrough Therapy designation to tolebrutinib for adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS). • The designation is based on positive results from the HERCULES phase 3 study, which demonstrated a 31% delay in disability progression compared to placebo. • Tolebrutinib is the first brain-penetrant BTK inhibitor to receive this designation for MS, addressing a critical unmet need in delaying disability progression. • Regulatory submissions for tolebrutinib are being finalized in the US and EU, with ongoing studies for primary progressive MS anticipated in H2 2025.

GLORIOUS Trial: Exenatide and Restrictive Oxygenation Fail to Improve Outcomes in Cardiac Surgery

6 months ago

• The GLORIOUS trial found that neither exenatide, a GLP-1 receptor agonist, nor restrictive oxygenation during cardiopulmonary bypass improved clinical outcomes after cardiac surgery. • The study, involving 1,389 patients, showed no reduction in mortality or morbidity from renal failure, stroke, or heart failure with either intervention. • Researchers suggest the interventions may have been ineffective due to the low-risk nature of the patient population undergoing elective CABG/AVR procedures. • Future research may focus on testing these strategies in higher-risk patients or exploring alternative interventions to improve perioperative outcomes.

Arch Biopartners Doses First Patient in Canada for Phase II Trial of LSALT Peptide in Cardiac Surgery-Associated Acute Kidney Injury

6 months ago

• Arch Biopartners has initiated patient recruitment and dosing in Canada for its Phase II trial of LSALT peptide, targeting cardiac surgery-associated acute kidney injury (CS-AKI). • The trial is a multi-center, randomized, double-blind, placebo-controlled study aiming to enroll 240 patients across sites in Canada and Turkey. • The primary objective is to evaluate the percentage of subjects with acute kidney injury within seven days following on-pump cardiac surgery, based on KDIGO criteria. • LSALT peptide targets the DPEP-1 pathway to prevent ischemia-reperfusion injury, a common cause of CS-AKI, for which there is currently no therapeutic treatment.

Arch Biopartners Doses First Patient in Phase II Trial for Cardiac Surgery-Associated Acute Kidney Injury

6 months ago

• Arch Biopartners has dosed the first patient in Canada for its Phase II trial evaluating LSALT peptide for preventing cardiac surgery-associated acute kidney injury (CS-AKI). • The multi-center, randomized, double-blind, placebo-controlled study aims to enroll 240 patients to assess LSALT peptide's efficacy in reducing AKI incidence within seven days post-surgery. • LSALT peptide targets the DPEP1 pathway to mitigate inflammation-related kidney damage, addressing a critical unmet need as there are currently no approved treatments for CS-AKI. • The trial is underway across five clinical sites in Turkey and expanding to include University Health Network and Unity Health Toronto to boost patient recruitment.

Arch Biopartners Doses First Patient in Phase II Trial of LSALT Peptide for Cardiac Surgery-Associated Acute Kidney Injury

6 months ago

• Arch Biopartners has initiated patient dosing in Canada for its Phase II trial of LSALT peptide, targeting cardiac surgery-associated acute kidney injury (CS-AKI). • The multi-center, randomized, double-blind, placebo-controlled study aims to enroll 240 patients internationally to assess LSALT peptide's efficacy in preventing AKI. • LSALT peptide targets the DPEP1 pathway to mitigate inflammation and injury in kidneys, lungs, and liver, with preclinical data supporting its potential in CS-AKI. • The trial's primary objective is to evaluate the percentage of subjects with acute kidney injury (AKI) within seven days following on-pump cardiac surgery.

Arch Biopartners Initiates Phase II Trial of LSALT Peptide for Cardiac Surgery-Associated Acute Kidney Injury

6 months ago

• Arch Biopartners has dosed the first patient in Canada for its Phase II trial of LSALT peptide, targeting cardiac surgery-associated acute kidney injury (CS-AKI). • The multi-center, randomized, double-blind, placebo-controlled study aims to enroll 240 patients to evaluate LSALT peptide's efficacy in preventing AKI post-cardiac surgery. • LSALT peptide targets the DPEP1 pathway to prevent inflammation-related kidney damage, addressing a critical unmet need in CS-AKI treatment. • Clinical sites in Canada and Turkey are actively recruiting patients, with the primary endpoint being the incidence of AKI within seven days post-surgery, based on KDIGO criteria.

Arch Biopartners' LSALT Peptide Phase II Trial Approved for Cardiac Surgery-Associated Acute Kidney Injury

8 months ago

• Arch Biopartners has received approval from Alberta Health Services for a Phase II trial of LSALT peptide in cardiac surgery-associated acute kidney injury (CS-AKI). • The trial is a multi-center, randomized, double-blind, placebo-controlled study with a target recruitment of 240 patients across multiple sites. • LSALT peptide targets the DPEP1 pathway and has shown promise in preclinical models for preventing ischemia-reperfusion injury to the kidneys. • CS-AKI is a common and serious complication following cardiac surgery, with prevalence up to 30% and associated with increased morbidity and mortality.