Sernova, FDA clarify details of diabetes drug trials

WASHINGTON Sernova has concluded a pre-investigational new drug application meeting with the Food and Drug Administration, establishing clinical trial requirements for its diabetes treatment Sertolin.

The meeting clarified details of the development path for the company’s xenotransplantation approach to treating diabetes, which involves cotransplantation of insulin-producing pig islet cells and Sertoli cells using a small subcutaneous medical device. Sertoli cells act as an anti-rejection agent, eliminating the need for anti-rejection drugs, which are immunosuppressants.

The next stage for Sertolin will be a pivotal large-animal trial, leading to a Phase I/II human trial, the company said.

Sernova plans to begin the large-animal trial in approximately six months, according to chief executive officer Justin Leushner. It is expected to take 18 months to complete and will assess the long-term safety and efficacy of Sertolin.