Arch Biopartners has initiated subject recruitment in its Phase II study aimed at assessing cilastatin’s efficacy in preventing acute kidney injury (AKI) caused by nephrotoxic pharmaceuticals.
The company manufactured cilastatin and supplied it for the trial.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Named ‘Prevention Of NephroToxin Induced Acute Kidney Injury with Cilastatin’ (PONTIAK), the trial has begun the recruitment process at its primary sites in Alberta, Canada.
It plans to enrol roughly 698 subjects across five hospital sites.
The company noted that the researchers will compare cilastatin against a placebo to determine its potential in preventing AKI in hospitalised individuals exposed to nephrotoxic medications.
These pharmaceuticals include widely used drugs such as antibiotics and chemotherapy agents, as well as imaging dyes, which are known to potentially cause kidney damage.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataSubjects in the trial will be given cilastatin or a placebo intravenously every six hours for up to 24 hours post their last exposure to nephrotoxic pharmaceuticals.
They will undergo daily blood tests to monitor kidney function while on treatment and a follow-up blood test 90 days post-randomisation.
Based at the Universities of Calgary and Alberta, the clinical team has obtained C$1.5m ($1.1m) in funding from the Canadian Institutes of Health Research (CIHR) for the Phase II trial.
An additional C$400,000 has been provided under the Accelerating Clinical Trials (ACT) initiative, which supports the evaluation of Canadian biotechnologies through randomised controlled trials.
Arch Biopartners CEO Richard Muruve said: “Congratulations to the PONTIAK team for achieving this milestone and beginning patient enrolment. This marks an important advancement in evaluating cilastatin as a potential first-in-class treatment to prevent AKI caused by exogenous toxins from several commonly used pharmaceutical products.”
While the trial is funded independently and spearheaded by the investigator, Arch Biopartners is exploring opportunities to support a complementary trial arm in another jurisdiction such as the US, pending an application to the Food and Drug Administration (FDA).
AKI encompasses a range of clinical conditions, from mild to severe injury, potentially leading to complete loss of renal function.
Cilastatin was initially developed by MSD Research Laboratories in the early 1980s to limit the dipeptidase-1 (DPEP1) role in the breakdown of the antibiotic imipenem.
Arch Biopartners holds exclusive licensing for method-of-use patents to repurpose the therapy as a new AKI treatment.
