MetaBlok (lsalt peptide) / Arch Biopartners - LARVOL DELTA

LSALT Peptide for Prevention or Attenuation of Acute Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Arch Biopartners Inc. | Trial completion date: Nov 2025 ➔ Nov 2026 | Trial primary completion date: Aug 2025 ➔ Aug 2026

Trial completion date • Trial primary completion date • Acute Kidney Injury • Cardiovascular • Nephrology • Renal Disease • CST3

Arch Biopartners Announces Ontario Research Ethics Board Approval to Proceed with Phase II Trial for LSALT Peptide Targeting Cardiac Surgery-Associated Acute Kidney Injury (CS-AKI) (GlobeNewswire) - "Arch Biopartners Inc...announced today that the University Health Network Research Ethics Board, through the Clinical Trials Ontario Streamlined Research Ethics Review System, has granted provincial ethics approval for the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI)...The clinical teams at Toronto General Hospital and St. Michael’s Hospital in Toronto are now seeking final internal approvals and completing final preparations to begin patient recruitment in the first quarter of 2025. The trial continues to recruit patients at the University of Calgary Hospital and five clinical sites in Turkey."

New P2 trial • Acute Kidney Injury

LSALT Peptide for Prevention or Attenuation of Acute Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Arch Biopartners Inc. | Trial completion date: Jun 2025 ➔ Nov 2025 | Trial primary completion date: Feb 2025 ➔ Aug 2025

Surgery • Trial completion date • Trial primary completion date • Acute Kidney Injury • Cardiovascular • Nephrology • Renal Disease

Multicentre, randomised, double-blind, placebo-controlled, proof of concept study of LSALT peptide as prevention of acute respiratory distress syndrome and acute kidney injury in patients infected with SARS-CoV-2 (COVID-19). (PubMed, BMJ Open) - P2 | "In a Phase 2 study, LSALT peptide was demonstrated to be safe and tolerated in patients hospitalised with moderate-to-severe COVID-19."

Journal • Acute Kidney Injury • Acute Respiratory Distress Syndrome • Infectious Disease • Inflammation • Nephrology • Novel Coronavirus Disease • Pulmonary Disease • Renal Disease • Respiratory Diseases • CXCL10

LSALT Peptide for Prevention or Attenuation of Acute Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Arch Biopartners Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Nov 2024 ➔ Jun 2025 | Initiation date: Sep 2023 ➔ Mar 2024 | Trial primary completion date: Sep 2024 ➔ Feb 2025

Enrollment open • Surgery • Trial completion date • Trial initiation date • Trial primary completion date • Acute Kidney Injury • Cardiovascular • Nephrology • Renal Disease

Arch Biopartners Announces Dosing of First Patient in Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury (GlobeNewswire) - "Arch Biopartners Inc...announced today that patient recruitment and dosing has begun in Turkey for the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI)...There are three hospital sites in Turkey actively screening cardiac surgery patients for this trial. Koşuyolu Research Hospital and Kocaeli University Research Hospital are located within and near Istanbul respectively. The third site is Erciyes University, Faculty of Medicine Organ Transplant & Dialysis Hospital, and is located in central Turkey. There are three additional hospital sites in Turkey pending activation into the trial....The CS-AKI Phase II trial is an international multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide. The recruitment target for the trial is 240 patients."

Trial status • Acute Kidney Injury • Immunology • Inflammation

CATCO: Treatments for COVID-19: Canadian Arm of the SOLIDARITY Trial (clinicaltrials.gov) - P3 | N=2900 | Active, not recruiting | Sponsor: Sunnybrook Health Sciences Centre | Recruiting ➔ Active, not recruiting | Trial primary completion date: Mar 2023 ➔ Mar 2024

Enrollment closed • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

LSALT Peptide for Prevention or Attenuation of Acute Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery (clinicaltrials.gov) - P2 | N=240 | Not yet recruiting | Sponsor: Arch Biopartners Inc.

New P2 trial • Surgery • Acute Kidney Injury • Cardiovascular • Nephrology • Renal Disease • CST3 • IGFBP7 • IL18 • IL1B • IL6 • TIMP2

LSALT Peptide vs. Placebo to Prevent ARDS and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19) (clinicaltrials.gov) - P2 | N=61 | Completed | Sponsor: Arch Biopartners Inc. | Active, not recruiting ➔ Completed | Trial completion date: Jun 2021 ➔ Jun 2022

Trial completion • Trial completion date • Acute Kidney Injury • Acute Respiratory Distress Syndrome • Infectious Disease • Nephrology • Novel Coronavirus Disease • Pulmonary Disease • Renal Disease • Respiratory Diseases • IL1A • IL1B

CATCO: Treatments for COVID-19: Canadian Arm of the SOLIDARITY Trial (clinicaltrials.gov) - P3 | N=2900 | Recruiting | Sponsor: Sunnybrook Health Sciences Centre | Phase classification: P2 ➔ P3 | Trial completion date: May 2022 ➔ May 2024 | Trial primary completion date: Mar 2022 ➔ Mar 2023

Phase classification • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Dipeptidase-1 governs renal inflammation during ischemia reperfusion injury. (PubMed, Sci Adv) - "Renal inflammation and the AKI phenotype were attenuated in Dpep1 mice or mice pretreated with DPEP1 antagonists, including the LSALT peptide, a nonenzymatic DPEP1 inhibitor...DPEP1, CD44, and ICAM-1 all contributed to the recruitment of monocyte/macrophages to the kidney following IRI. These results identify DPEP1 as a major leukocyte adhesion receptor in the kidney and potential therapeutic target for AKI."

Journal • Acute Kidney Injury • Immunology • Inflammation • Nephrology • Renal Disease • Reperfusion Injury • CD44 • ICAM1

LSALT Peptide vs. Placebo to Prevent ARDS and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19) (clinicaltrials.gov) - P2; N=60; Active, not recruiting; Sponsor: Arch Biopartners Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Acute Kidney Injury • Acute Respiratory Distress Syndrome • Infectious Disease • Nephrology • Novel Coronavirus Disease • Pulmonary Disease • Renal Disease • Respiratory Diseases • CXCL10 • IL6

Turkish Ministry of Health Approves Increase in Patient Recruitment into the Phase II Trial for LSALT Peptide (GlobeNewswire) - "Arch Biopartners Inc....announced today that it received approval from the Turkish Ministry of Health, Pharmaceuticals and Medical Devices Agency (MoH) to recruit up to twenty additional patients into the Phase II trial of its lead drug LSALT peptide...The approval from the MoH doubles the number of patients allowed into the Turkish arm of the trial from twenty to forty. The first twenty patients in Turkey have already been recruited into the trial and have completed treatment. Patient recruitment is expected to resume this week in two hospital sites in Istanbul and Ankara....Patient recruitment in this 60-patient phase II trial continues in four clinical sites in Canada and the USA, with 46 patients recruited to date between North America and Turkey."

Enrollment status • Trial status • Infectious Disease • Novel Coronavirus Disease

Arch Biopartners Receives Health Canada Authorization to Amend Phase II Trial Protocol for LSALT Peptide (GlobeNewswire) - "Arch Biopartners Inc...announced today that Health Canada has provided a No Objection Letter for the Company’s protocol amendments for the Phase II trial of its lead drug LSALT peptide (Metablok)...in patients with severe cases of COVID-19....The changes to the protocol were designed to facilitate enrollment and execution of the sixty-patient study...The amendments approved by Health Canada include the lowering of the minimum age of patients admissible into the trial to 18 years from 45 and a simplified treatment regimen including the reduction in daily blood draws based on the safety profile...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."

Clinical protocol • Trial status • Infectious Disease • Novel Coronavirus Disease

University of Calgary Joins the Phase II Trial of LSALT Peptide for the Treatment of Complications in Hospitalized COVID-19 Patients (GlobeNewswire) - "Arch Biopartners Inc....announced today that the University of Calgary Cumming School of Medicine has joined the Phase II trial of its lead drug LSALT peptide (Metablok)...The addition of the Canadian site increases the number of countries participating in the Phase II trial to three, joining sites in the United States and in Turkey. Arch is currently exploring opportunities to add additional clinical sites in all three countries where the number of hospitalized COVID-19 patients has grown significantly."

Trial status • Infectious Disease • Novel Coronavirus Disease

Arch Biopartners Closes Non-Brokered Private Placement (GlobeNewswire) - "Arch Biopartners Inc...has closed the non-brokered private placement...Pursuant to the Offering, Arch issued 430,000 common shares priced at CAD $1.50 per common share (the 'Common Shares') for net proceeds of $500,000 USD (approximately $645,000 CAD) (the 'Offering')....The proceeds supplement the Government of Canada’s commitment of up to $6.7 million for the Phase II development of Metablok (LSALT Peptide), the Company’s therapeutic drug candidate to prevent organ inflammation and injury in patients hospitalized with COVID-19."

Financing • Infectious Disease • Novel Coronavirus Disease

Arch Biopartners Receives Government of Canada Funding to Support Phase II Therapeutic Trial of Metablok for COVID-19 (GlobeNewswire) - "Arch Biopartners Inc....announced today that the Government of Canada has awarded a contribution of up to $6.7 million from the department of Innovation, Science and Economic Development (ISED) to support the Phase II development of Metablok...The funding will help Arch advance Metablok through the current Phase II trial targeting the prevention of acute lung injury, acute kidney injury and other complications caused by inflammation in hospitalized patients with moderate to severe cases of COVID-19."

Financing • Infectious Disease • Novel Coronavirus Disease

VA San Diego Healthcare System Joins the Phase II Trial of LSALT Peptide for the Treatment of Complications in Hospitalized COVID-19 Patients (GlobeNewswire) - "Arch Biopartners Inc....announced today that the Veterans Affairs San Diego Healthcare System (VASDHS) has started recruiting patients for the Phase II trial of its lead drug LSALT peptide, targeting the prevention of acute lung injury, acute kidney injury and other complications caused by inflammation in hospitalized patients with moderate to severe cases of COVID-19....The VASDHS is the fifth hospital to be activated into the trial...Arch is currently exploring opportunities to add Canadian clinical sites into the trial...The Phase II results will be used to design the Phase III trial, including greater patient numbers to more fully evaluate efficacy and safety in COVID-19 patients."

Enrollment status • Acute Kidney Injury • Infectious Disease • Novel Coronavirus Disease • Renal Disease

Arch Biopartners Announces Dosing of First Patient in Turkey in Phase II Trial of LSALT peptide to Treat Complications from Covid-19 (GlobeNewswire) - "Arch Biopartners Inc....announced today that patient dosing in Turkey has begun in the Phase II trial of its lead drug LSALT peptide....The first patient was dosed in Istanbul yesterday and patient recruitment at the Istanbul site is now ongoing. Additional patients are expected to be enrolled this week at a second clinical site in Ankara....The Phase II trial continues to recruit patients in two hospital sites in the U.S. (in Florida and Louisiana) while the Company is exploring the opportunity to add Canadian clinical sites to the trial."

Enrollment status • Trial status • Infectious Disease • Novel Coronavirus Disease

LSALT Peptide vs. Placebo to Prevent ARDS and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19) (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: Arch Biopartners Inc.; Not yet recruiting ➔ Recruiting; Initiation date: Jul 2020 ➔ Oct 2020

Clinical • Enrollment open • Trial initiation date • Acute Kidney Injury • Acute Respiratory Distress Syndrome • Infectious Disease • Nephrology • Novel Coronavirus Disease • Renal Disease • Respiratory Diseases

First Patient Dosed in Phase II Trial to Treat Complications in COVID-19 (GlobeNewswire) - "Arch Biopartners Inc....announced today it has dosed the first patient in the Phase II trial of its lead drug LSALT peptide, targeting prevention of acute lung injury, acute kidney injury and other complications caused by inflammation in hospitalized patients with moderate to severe cases of COVID-19. The first patient dosed was at the Broward Health Medical Center in Florida where patient recruitment into the trial continues. Arch will begin screening and recruiting patients next week at clinical sites in Louisiana and in Turkey."

Trial status • Infectious Disease • Novel Coronavirus Disease

Arch Biopartners Receives Approval from Turkish Ministry of Health to Proceed with Phase II Trial for LSALT Peptide; Begins Screening Patients in Florida (GlobeNewswire) - "Arch Biopartners Inc....announced today that it received approval in Turkey from the Ministry of Health to proceed with the Phase II trial of its lead drug LSALT peptide (Metablok)....Activation of clinical sites in Istanbul and Ankara and patient enrollment into the trial will begin imminently in Turkey....In the United States, patient screening has begun at the study’s first hospital site in Florida. Arch Biopartners continues to prepare the activation of two additional U.S. sites into the Phase II trial."

Enrollment status • Trial status • Infectious Disease • Novel Coronavirus Disease

Arch Biopartners Receives Ethics Committee Approval in Turkey for Phase II Trial for LSALT Peptide (GlobeNewswire) - "Arch Biopartners Inc....announced today that it received approval in Turkey from the Istanbul University Ethics Committee for the Phase II trial of its lead drug LSALT peptide (Metablok)....A regulatory review conducted by the Turkish Ministry of Health (MoH), expected to be completed by mid-September. Once the trial is approved by the MoH, activation of clinical sites in Istanbul and Ankara will take place and patient enrollment into the trial will commence....'At the same time, we continue to progress on a day-to-day basis to enrol the first U.S patient into this trial...'"

Trial status • Infectious Disease • Novel Coronavirus Disease

Arch Biopartners Announces Application to the Turkish Ministry of Health to Conduct Phase II Trial for Treatment of Complications in COVID-19 patients (GlobeNewswire) - "Arch Biopartners Inc....today announced that applications to the Turkish Ministry of Health and local Ethics Committee have been submitted to obtain permission to recruit COVID-19 patients in Turkey for the Phase II trial....Arch is planning to expand the existing Phase II trial about to begin in the U.S. by adding hospital sites in İstanbul and Ankara, Turkey....Progress toward the start of the trial continues in the U.S. with the dosing of the first patient expected to occur this month. Recruitment of patients in Turkey will follow once the trial has been approved by the Turkish regulatory authorities, expected during the month of September."

Enrollment status • Trial status • Infectious Disease • Inflammation • Novel Coronavirus Disease

Arch Biopartners Receives Independent Institutional Review Board Approval for Phase II Trial for LSALT Peptide (GlobeNewswire) - "Arch Biopartners Inc....announced today that it received independent Institutional Review Board (IRB) approval for the Phase II trial of its lead drug LSALT peptide (Metablok) targeting acute lung injury and acute kidney injury caused by inflammation in patients with severe cases of COVID-19....'We are currently evaluating 3 new hospital sites in the U.S. in addition to the first site already selected in Florida. We look forward to dosing the first patient as soon as site evaluations are complete and the LSALT peptide drug product is delivered to the sites.'"

New P2 trial • Infectious Disease • Novel Coronavirus Disease