AM-Pharma cuts staff, says goodbye to CEO as lead kidney injury asset redirected

After failing in a phase 3 study for a severe kidney complication of sepsis, AM-Pharma is redirecting its lead program to a different kind of kidney damage. Along with the revised clinical development strategy, the Dutch biotech is cutting staff and getting a new CEO.

A phase 3 trial for ilofotase alfa in sepsis-associated acute kidney injury (SA-AKI) was halted for futility in October 2022 after failing to improve the rate of all-cause deaths at 28 days. SA-AKI is a complex and severe complication of sepsis when the body’s infection-fighting mechanism turns on itself. The condition has a high rate of death and is associated with poor outcomes.

Despite failing the study, AM-Pharma noted a reduction in major adverse kidney events by day 90, with an investigator saying “the renal benefit observed in this study in ilofotase alfa-treated patients cannot be ignored.” This potential benefit was revealed in a pre-specified secondary analysis of all 649 patients.

AM-Pharma has decided to heed the warning, but it’s going to take some growing pains to get there. The company announced Tuesday an unspecified workforce reduction but declined in an email to specify the number of people affected. The company’s LinkedIn page lists 33 employees.

Long-time CEO Erik van den Berg will also pass the reins to Juliane Bernholz, Ph.D., who had been serving as chief operating officer. Van den Berg had held the top role since 2011 and will now join the company’s supervisory board and remain a strategic advisor.

Ilofotase alfa will proceed in two indications, with cardiac surgery-associated renal damage serving as the lead indication. A phase 2 study will test the therapy in 150 patients who are at risk of developing renal damage based on pre-operative kidney function and scheduled for a complex open-heart surgery.

A separate phase 1b study is already underway to use ilofotase alfa as an enzyme replacement therapy for patients with the rare bone metabolism disorder hypophosphatasia. Initial clinical results are expected before the end of the year.

AM-Pharma boasts some major Big Pharma investors, including Pfizer, Takeda and AbbVie. Others include Nestle, Cowen Healthcare Investments and Forbion. Pfizer put down $87.5 million in 2015 to take a minority interest in the Utrecht, Netherlands-based company but also snagged an option to buy it outright for $512.5 million if interested once phase 2 results for ilofotase alfa were ready. The New York Big Pharma walked away after getting a look at the data in 2018.

The revised clinical development plan is supported by existing investors who have supplied additional funding, although AM-Pharma did not provide details.