HOUSTON, May 31, 2022 – FibroBiologics, a clinical-stage biotechnology company developing fibroblast-based therapeutic cures for chronic diseases, will present preclinical and safety-centered limited clinical trial data for the single-dose infusion of tolerogenic human dermal fibroblasts (HDFs) data at the 2022 Consortium of Multiple Sclerosis Centers Annual Meeting being held in person from June 1 – 4, at the Gaylord National Resort and Convention Center in National Harbor, Maryland.
Multiple Sclerosis (MS), a T cell-mediated autoimmune disorder targeting the myelin sheath of the axon process of the neurons, leads to severe progressive cognitive impairment, sensory deprivation, and weakened coordination. FibroBiologics is investigating the therapeutic capability of human dermal fibroblasts in reducing the rate of progression of MS, thereby slowing down the disruption of communication between the brain and the body. Extensive preclinical studies of tolerogenic HDFs, which can elicit immunological tolerance, were performed in the experimental autoimmune encephalomyelitis (EAE) animal model of multiple sclerosis. The phase 0/1 primary safety clinical trial studied a single-dose infusion of tolerogenic HDFs into four relapsing-remitting and one secondary progressive MS patient. Results indicated that administration of HDFs in the EAE model of MS led to a Treg-dependent disease inhibition that was significantly better than that achieved with adipose or bone marrow-derived MSCs. In addition, the safety clinical trial primary outcome indicated a strong correlation for CBC, blood chemistry, and electrocardiogram data for all patients when compared to pre-infusion test results with no adverse events reported.
“Tolerogenic HDFs are capable of suppressing pathogenic T cell activation, stimulating T regulatory (Treg) cell expansion, inhibiting dendritic cells (DC) maturation, stimulating oligodendrocyte expansion and myelin protein expression, as was evidenced by our in vivo studies,” said Dr. Hamid Khoja, Chief Scientific Officer at FibroBiologics. “While we are excited about the promise of HDFs, we understand that further studies are required, and to that end, FibroBiologics is in the process of submitting an IND application to the US FDA to study the safety and efficacy profile of various concentrations of HDFs and the impact of multiple-dose infusions over an eighteen-month study period.”
Based in Houston, FibroBiologics is a regenerative medicine company developing a pipeline of treatments for chronic diseases using fibroblast cells. FibroBiologics holds 150+ US and international issued patents/patents pending across various clinical pathways, including disc degeneration, orthopedics, multiple sclerosis, wound healing, reversing organ involution, and cancer. FibroBiologics represents the next generation of medical advancement in cell therapy. For more information, visit www.FibroBiologics.com.