Avobis Bio’s Crohn Disease Cell Therapy Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation
BOSTON,MA – Avobis Bio today announced the U.S. Food and Drug management (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its lead cell therapy candidate,AVB-114,for the treatment of Crohn disease. The designation is intended to expedite the development and review of promising regenerative medicine products,offering potential benefits to the estimated 1.6 million Americans living with inflammatory bowel disease (IBD), including Crohn’s. This RMAT designation follows positive early clinical data and underscores the potential of AVB-114 to address a notable unmet need in Crohn’s disease management, where current therapies frequently enough fall short of providing durable remission.
The RMAT designation provides Avobis Bio with increased access to FDA resources and guidance, possibly accelerating the clinical development pathway for AVB-114. Crohn’s disease,a chronic inflammatory condition of the gastrointestinal tract,currently lacks curative treatment options,and many patients experience recurring flares despite available therapies. AVB-114, a novel allogeneic adipose-derived mesenchymal stem cell (MSC) therapy, aims to modulate the immune system and promote tissue repair, offering a potentially transformative approach to treating the disease.
avobis is not alone in pursuing cell-based therapies for Crohn’s disease. Cellularity’s PDA-001, a placental-derived mesenchymal-like adherent stromal cell (MLASC) therapy, recently completed a phase 2 clinical trial (NCT01155362) and is awaiting an end of phase 2 meeting with the FDA. cgtlive® has previously spoken to Adrian Kilcoyne, MD, MPH, MBA, the chief medical officer of Celularity, about the company’s work on MLASC therapy for Crohn disease.4 He explained that Celularity previously carried out several phase 1 clinical trials evaluating a placental-derived MLASC approach to treating Crohn disease and that these legacy trials initially measured efficacy outcomes at early time points, such as 12 weeks or 3 months posttreatment.
“…I have said repeatedly that I don’t believe the mesenchymal stem cell [MSC] studies have failed, I believe the study designs have failed the MSCs,” Kilcoyne told CGTLive. ”I think now with our understanding of the mode of action, we can design the end points a lot better [and] we can design the time points a lot better so what we may have are longer studies, but with the appropriate end points.”4
3 NCT01155362
4 https://www.cgtlive.com/view/adrian-kilcoyne-md-mph-mba-reevaluating-placental-derived-mesenchymal-like-adherent-stromal-cell-therapy-crohn-disease
