Seres Therapeutics shared a post on LinkedIn:
“Today we’re thrilled to announce that our lead live biotherapeutic, SER-155, has received Breakthrough Therapy Designation from the FDA for the reduction of blood stream infections in adults undergoing an allogeneic stem cell transplant.
This designation ensures communication and guidance from FDA to expedite the development of medicines which are intended to treat serious or life-threatening diseases, and in which preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint over available therapies.
We look forward to working closely with the FDA in the new year to discuss the next SER-155 clinical study, which we believe could be a single registrational study for efficacy.
Read more in our latest release.”
