Arch Biopartners Stock Price, News & Analysis

Arch Biopartners (OTCQB: ACHFF) has initiated patient recruitment for its Phase II PONTIAK trial, evaluating cilastatin's effectiveness in preventing drug-toxin-related Acute Kidney Injury (AKI). The study will enroll 698 patients across five hospital sites in Alberta, Canada.

The trial has secured substantial funding, including $1.5 million from the Canadian Institutes of Health Research and $400,000 from the Accelerating Clinical Trials initiative. Arch Biopartners has manufactured the first standalone cilastatin drug product for the trial and is exploring opportunities to expand the study to the United States.

Arch Biopartners (ACHFF) has received ethics approval from the University Health Network (UHN) Research Ethics Board for Toronto General Hospital (TGH) to participate in their ongoing Phase II trial of LSALT peptide. The trial focuses on preventing and treating cardiac surgery-associated acute kidney injury (CS-AKI).

TGH will become the seventh global site and second Canadian location for patient recruitment in this clinical study. The company plans to reduce recruitment in Turkey while increasing Canadian participation to diversify the trial's geographic and demographic data coverage.

Arch Biopartners Inc. (TSX Venture: ARCH, OTCQB: ACHFF) announced that its drug candidate cilastatin will participate in the PONTIAC Phase II trial, targeting acute kidney injury (AKI) caused by drug toxins. The 900-patient trial, funded by $1.9 million in grants, will evaluate cilastatin's efficacy in preventing AKI from antibiotics, chemotherapeutics, and radiographic contrast. Arch is repurposing cilastatin, a dipeptidase-1 inhibitor, as an AKI treatment, leveraging its unique ability to block toxin uptake in kidney tissue. This trial complements Arch's ongoing Phase II study of LSALT peptide for cardiac surgery-associated AKI. Together, these trials target about 50% of hospital AKI cases, for which no treatment currently exists.

Arch Biopartners has announced the completion of the good manufacturing practice (GMP) glass vial filling stage for cilastatin, their second drug candidate aimed at preventing acute kidney injury (AKI). Dalton Pharma Services finalized this stage, and over the next six to eight weeks, will complete the quality control process. This will result in the release of the first-ever stand-alone cilastatin drug product, which is set to be used in a Phase II trial for drug toxin-related AKI in hospitalized patients. The trial is expected to commence in late 2024. Arch will partner with Canadian clinical researchers, providing cilastatin, scientific, and regulatory support. The company holds method of use patents in North America and Europe for repurposing cilastatin as an AKI treatment. This milestone is a significant step in their plans to introduce cilastatin as a novel treatment for toxin-related AKI.

Arch Biopartners has received ethics approval from the University of Calgary's Conjoint Health Research Ethics Board to initiate a Phase II trial for the LSALT peptide. This trial targets the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). The approval allows the clinical team at the University of Calgary to finalize preparations and training for patient recruitment. This process is expected to continue until final approval from Alberta Health Services is obtained. Patient recruitment is already ongoing at five sites in Turkey since March, with Health Canada approving recent protocol enhancements. These enhancements are still pending approval from the Turkish Ministry of Health. CEO Richard Muruve expressed satisfaction with the trial's progress and anticipates that starting dosing in Calgary and later in Toronto will significantly benefit the trial.