Innate Pharma Faces Setback as FDA Places Partial Hold on Lacutamab Studies

The biopharmaceutical company, Innate Pharma, received a blow when the U.S. Food and Drug Administration (FDA) announced a partial hold on the studies of their leading proprietary program, lacutamab. This decision came after the unfortunate death of a patient.

The partial hold has temporarily paused new patient enrollment in both Phase 2 and Phase 1b studies of lacutamab. The FDA's action was prompted by a fatal case of hemophagocytic lymphohistiocytosis, a rare hematologic disorder.

In response, Innate Pharma is actively working to address the FDA's requests. This includes incorporating risk mitigation and management strategies specifically aimed at preventing hemophagocytic lymphohistiocytosis in future lacutamab studies.

However, it is important to note that patients already receiving treatment and experiencing clinical benefits will be allowed to continue their therapy uninterrupted. Moreover, this setback is not expected to delay the release of Phase 2 study data as all patients have already been recruited.

Despite this setback, Innate Pharma remains resilient and committed to moving forward with their groundbreaking research. As the situation develops, the company will continue to work closely with the FDA to ensure the safety and efficacy of lacutamab.

Innate Pharma's shares have taken a hit due to this news, with premarket trading showing an 11% decline from $2.47 to $2.19.