Drugs / LSALT
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | — | cardiac surgery-associated acute kidney injury | 2023-12-13 | “announced today it has submitted a Clinical Trial Application to Health Canada to obtain permission to proceed with a Phase II trial for LSALT peptide” archbiopartners.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT05879432 | Mar 2024 → Mar 2027 expected | acute kidney injury | Arch Biopartners Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 30
| Date | Issuer | Release |
|---|---|---|
| 2025-01-08 | Arch Biopartners Inc. | Regulatory 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) archbiopartners.com ↗ |
| 2024-09-11 | Arch Biopartners Inc. | Regulatory Arch Biopartners Announces Alberta Health Services Approval to Proceed with Phase II Trial for LSALT Peptide Targeting Cardiac Surgery-Associated Acute Kidney Injury (CS-AKI) archbiopartners.com ↗
Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that Alberta Health Services (AHS) has approved the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). |
| 2024-03-18 | Arch Biopartners Inc. | Results Arch Biopartners Clinical Team Publishes Data from Phase II Trial for LSALT Peptide Targeting Organ Inflammation in Hospitalized Patients Infected with SARS-CoV-2 archbiopartners.com ↗ |
| 2024-01-10 | Arch Biopartners Inc. | Regulatory Arch Biopartners Receives Health Canada Approval to Conduct Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury archbiopartners.com ↗
announced today that it has received a No Objection Letter from Health Canada to conduct a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). |
| 2024-01-03 | Arch Biopartners Inc. | Regulatory Arch Biopartners Receives Approval from the Turkish Ministry of Health to Proceed with Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury archbiopartners.com ↗ |
| 2023-12-21 | Arch Biopartners Inc. | Regulatory Arch Biopartners Receives Approval from Ethics Committee in Turkey to Proceed with Phase II Cardiac Surgery Associated-Acute Kidney Injury Trial for LSALT Peptide archbiopartners.com ↗
Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it received approval in Turkey from the Kocaeli University Clinical Research Ethics Committee to proceed with a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). |
| 2023-12-13 | Arch Biopartners Inc. | Regulatory Arch Biopartners Submits Application to Health Canada to Conduct the Phase II Cardiac Surgery Associated-Acute Kidney Injury Trial for LSALT Peptide archbiopartners.com ↗
Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today it has submitted a Clinical Trial Application to Health Canada to obtain permission to proceed with a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). |
| 2023-09-22 | Arch Biopartners Inc. | Regulatory Arch Biopartners Submits Application to the Turkish Ministry of Health to Conduct a Phase II Cardiac Surgery Associated-Acute Kidney Injury Trial for LSALT Peptide archbiopartners.com ↗ |
| 2023-06-27 | Arch Biopartners Inc. | Regulatory Arch Biopartners Receives Permission From U.S. FDA to Proceed With Phase II Acute Kidney Injury Trial archbiopartners.com ↗
Approval from FDA to initiate Phase II trial with LSALT peptide to target cardiac surgery-associated acute kidney injury (CS-AKI) |
| 2023-04-18 | Arch Biopartners Inc. | Results Arch Biopartners Announces Positive Results of Dose Escalation Human Trial for LSALT Peptide archbiopartners.com ↗ |
| 2022-02-14 | Arch Biopartners Inc. | Regulatory Canadian Treatments for COVID-19 (CATCO) Trial Receives Approval from Health Canada to Amend Protocol to include LSALT Peptide (Metablok) archbiopartners.com ↗
Health Canada has issued a No Objection Letter for the Clinical Trial Application – Amendment to the CATCO team as part of its approval process. |
| 2022-02-03 | Arch Biopartners Inc. | Results Arch Scientists Publish Data on the Mechanism of Action and Efficacy of Lead Drug Candidate LSALT Peptide in the Prevention of Acute Kidney Injury archbiopartners.com ↗
Importantly, the study also confirmed the mechanism of action of two DPEP-1 inhibitors, the LSALT peptide (Metablok) and cilastatin that effectively protected the kidney during ischemia reperfusion injury. |
| 2021-03-30 | Arch Biopartners Inc. | Regulatory Turkish Ministry of Health Approves Increase in Patient Recruitment into the Phase II Trial for LSALT Peptide archbiopartners.com ↗
The approval from the MoH doubles the number of patients allowed into the Turkish arm of the trial from twenty to forty. |
| 2021-03-16 | Arch Biopartners Inc. | Regulatory Arch Biopartners Receives Health Canada Authorization to Amend Phase II Trial Protocol for LSALT Peptide archbiopartners.com ↗
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 observed in prior patients. |
| 2021-02-02 | Arch Biopartners Inc. | Regulatory Arch Biopartners Receives Ethics Committee Approval in Turkey to Dose Additional Patients in the Phase II Trial for LSALT Peptide archbiopartners.com ↗
The Ethics Committee approval to double the number of allowable patients in the Turkish portion of the study from twenty to forty was based on the safety results of the trial to date and the ongoing clinical need for treatments for hospitalized COVID-19 patients. |
| 2020-10-07 | Arch Biopartners Inc. | Regulatory Arch Biopartners Receives Approval from Turkish Ministry of Health to Proceed with Phase II Trial for LSALT Peptide; Begins Screening Patients in Florida archbiopartners.com ↗
In the United States, patient screening has begun at the study’s first hospital site in Florida. |
| 2020-09-10 | Arch Biopartners Inc. | Regulatory Arch Biopartners Receives Ethics Committee Approval in Turkey for Phase II Trial for LSALT Peptide archbiopartners.com ↗
The Ethics Committee approval of the trial will be followed by a regulatory review conducted by the Turkish Ministry of Health (MoH), expected to be completed by mid-September. |
| 2020-09-01 | Arch Biopartners Inc. | Regulatory Arch Biopartners Announces Application to the Turkish Ministry of Health to Conduct Phase II Trial for Treatment of Complications in COVID-19 patients archbiopartners.com ↗
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 of its lead drug, LSALT peptide (Metablok). |
| 2020-06-16 | Arch Biopartners Inc. | Regulatory FDA Grants Arch Biopartners Permission to Proceed with Phase II trial to Evaluate Metablok (LSALT peptide) for the Treatment of COVID-19 patients archbiopartners.com ↗
The decision by the FDA to authorize the initiation of the Phase II trial came following the Company’s submission of an Investigational New Drug application to the FDA late last week. |
| 2020-06-15 | Arch Biopartners Inc. | Regulatory Arch Biopartners Announces FDA Acknowledgement of its Investigational New Drug Application for Metablok (LSALT peptide) archbiopartners.com ↗
The submission of the IND application to the FDA was recently made by Arch. |
| 2020-06-08 | Arch Biopartners Inc. | Regulatory Arch Biopartners Submits Investigational New Drug Application to the FDA for Metablok (LSALT peptide) archbiopartners.com ↗
today announced it has submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for its lead drug Metablok (LSALT peptide) to conduct a Phase II trial to prevent acute organ inflammation and injury experienced by patients with COVID-19. |
| 2020-05-08 | Arch Biopartners Inc. | Regulatory Arch Biopartners Receives Health Canada Approval to Conduct COVID-19 Phase II Human Trial archbiopartners.com ↗
today announced it has received a No Objection Letter from Health Canada to conduct a Phase II human trial for its lead drug LSALT peptide (Metablok) to prevent organ inflammation experienced by patients with COVID-19. |
| 2020-04-23 | Arch Biopartners Inc. | Regulatory Arch Biopartners Submits Application to Health Canada to Conduct COVID19 Phase II Human Trial for Metablok to Prevent Lung and Kidney Inflammation archbiopartners.com ↗
today announced it has submitted a Clinical Trial Application to Health Canada for a Phase II human trial for its lead drug Metablok (LSALT peptide) to prevent lung and kidney inflammation in patients with COVID19. |
| 2020-03-31 | Arch Biopartners Inc. | Results Arch Biopartners Releases New Video Showing Metablok Reducing Lung Inflammation in an Animal Model archbiopartners.com ↗
today released a new video on its website showing the efficacy of its lead drug candidate Metablok in reducing neutrophil recruitment in a mouse model of lung inflammation. |
| 2020-03-17 | Arch Biopartners Inc. | Results Arch Biopartners Safely Completes Expanded Dosing of METABLOK in Phase I Human Trial and Begins Focus on Phase II Trial archbiopartners.com ↗
This final group received the highest daily dose of Metablok tested to date for three consecutive days and met the primary endpoints of safety and tolerability. |
| 2019-12-18 | Arch Biopartners Inc. | Results Arch Biopartners Announces Metablok Achieves Primary Endpoints of Safety and Tolerability in Phase I Trial archbiopartners.com ↗
Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF) announced today that the Phase I human trial of Metablok (LSALT peptide) has completed dosing of all scheduled volunteers and Metablok has met the primary endpoints of safety and tolerability. |
| 2019-11-07 | Arch Biopartners Inc. | Results Arch Provides Interim Update on Phase I Trial for Metablok (LSALT Peptide) archbiopartners.com ↗
Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF) announced today that the Phase I human trial of Metablok (LSALT peptide), the Company’s lead drug candidate for treating organ damage caused by inflammation, has met the primary endpoints of safety and tolerability in the trial’s three single ascending dose cohorts of healthy volunteers. |
| 2019-08-22 | Arch Biopartners Inc. | Results Arch Scientists Publish Data on the Mechanism of Action and Efficacy of Lead Drug Candidate Metablok in the Prevention of Inflammation and Organ Damage archbiopartners.com ↗
The findings identify DPEP1 as the specific target of Metablok and establishes its role as a physical adhesion molecule for neutrophils during recruitment to the endothelium. |
| 2019-03-19 | Arch Biopartners Inc. | Regulatory UPDATE – Arch Biopartners Receives Approval to Perform Phase I Clinical Trial for Metablok in Australia archbiopartners.com ↗
Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), today announced that it has been granted approval by the Alfred Hospital Ethics Committee to perform a Phase I clinical trial for Metablok, the Company’s lead drug candidate for treating acute kidney injury and other organ damage caused by inflammation. |
| 2018-10-29 | Arch Biopartners Inc. | Results Arch Biopartners Provides Toxicology Update for Metablok archbiopartners.com ↗
In seven day studies involving rodents and another larger animal species, there were no significant drug-related side effects in the toxicology assessments. |
All press releases naming this drug 60 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | LSALT | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05879432 ↗ |
| Action | Inhibit | “through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver” NCT05879432 ↗ |
| Modality | Peptide | “LSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH” NCT05879432 ↗ |
| Route | Intravenous | “LSALT peptide 10 mg IV administered over 1 hour twice daily” NCT05879432 ↗ |
| Target | DPEP1 | “binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity” NCT05879432 ↗ |