Manufacturing concerns sideline INmune's US Alzheimer's trial

The FDA has blocked the small biotech INmune Bio from moving an Alzheimer’s disease therapy into a phase 2 clinical study on manufacturing concerns.

INmune said after market Monday that it had received a letter from the agency notifying it of a clinical hold for XPro1595, a TNF inhibitor that aims to reduce neuroinflammation to stop or slow the progression of cognitive and psychiatric symptoms of the devastating neurological disease.

The FDA decided to place the hold on INmune’s investigational new drug application and requested more information on chemistry, manufacturing and controls for XPro1595, also called XPro, which was recently manufactured for the study.

The short update from INmune provided few details on the exact nature of the FDA’s concerns but said the agency would provide a full clinical hold letter to the company in about 30 days.

INmune promised to update after discussions with the FDA.

A phase 2 trial of XPro remains underway in Australia and is still enrolling patients. In a phase 1 trial, INmune linked XPro to a reduction in neuroinflammation, teeing up the move to phase 2.

INmune’s approach to Alzheimer’s differs from the leading therapies under development by major pharmaceutical companies. The biotech is approaching the problem as an immunologic disease, hoping to control inflammation that could lead to the cognitive symptoms of the disease.

Shares in INmune plummeted 27% as the markets opened Tuesday to $5.28, compared to a prior close of $7.27.