BRIEF—Capsida Biotherapeutics reveals patient death in clinical trial

Privately-held US drug developer Capsida Biotherapeutics has shared the news that the first patient to participate in its SYNRGY trial for STXBP1-related disorders passed away.

A brief company statement noted: “We understand this devastating news will raise questions and uncertainty, and we are working with urgency to gather information and find answers. We have voluntarily paused the CAP-002 SYNRGY study while we determine the root cause of the patient’s passing. As we continue to work closely with our partners and relevant experts, we have alerted the FDA and will be providing them with a full report in compliance with regulations. Once this work is complete, we can begin to assess next steps with respect to this important program.”

Capsida Biotherapeutics is one of a group of companies and labs engineering new viruses potentially capable of safely ferrying genes deep into the brain. Its first effort was designed to treat STXBP1 encephalopathy, a condition that can cause seizures, developmental delays, and other symptoms.