Sigilon Announces a Priority Shift in Light of Clinical Trial Setbacks

The phase 1/2 trial of SIG-001 for hemophilia A has been on an FDA clinical hold since July 2021.

Sigilon Therapeutics recently announced a “strategic reprioritization,” as the company shifts focus to their non-hemophilia, investigational therapies, including those for MPS-1 and diabetes. This closely follows recent setbacks associated with their phase 1/2 clinical study of SIG-001 in individuals with severe or moderately severe hemophilia.

These setbacks are linked, in large part, to one of the three patients participating in the study who experienced an inhibitor –  the U.S. Food and Drug Administration subsequently placed the trial on a clinical hold this past summer. Subsequent investigations related to this patient also revealed that the encapsulating spheres integral to the cell-based therapy, had become fibrosed.

“There have been key learnings in our Phase 1/2 trial of SIG-001 for Hemophilia A. While we continue to investigate the findings from our SIG-001 study to help inform our development of the platform, following a review of our programs, we have made the strategic decision to refocus our pipeline. We will be prioritizing MPS-1—a rare lysosomal disease—with our product candidate that is designed to produce the same enzyme as the native human structure, and Type 1 diabetes, alongside our partner, Eli Lilly, with a program that utilizes iPSC derived islets,” said Rogerio Vivaldi, President and CEO of Sigilon. “As part of our plan to refocus our pipeline, we will also make workforce reductions, which are expected to extend our cash
runway.”

Source: Sigilon, December, 2021