FibroBiologics, Inc. announced it will present in vitro and in vivo preclinical data using allogeneic human dermal fibroblasts (HDFs) and HDF spheroids as well as primary safety phase 0/1 clinical trial data for the single-dose infusion of HDFs during the poster sessions at the upcoming Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2024 on February 29, at the Palm Beach County Convention Center and the Hilton West Palm Beach in West Palm Beach, Florida. The National Institutes of Health describes multiple sclerosis (MS) as a T-cell-mediated autoimmune disorder in which the immune system targets and destroys the myelin sheath of axons in the central nervous system, leading to severe and progressive cognitive impairment, sensory deprivation, and weakened coordination. FibroBiologics is investigating the therapeutic potential of using HDFs as a treatment for MS through immune modulation and stimulation of myelin expression by oligodendrocytes to rebuild the damaged myelin sheath.

Extensive preclinical studies were conducted using allogeneic HDFs in the experimental autoimmuneencephalomyelitis (EAE) animal model of MS. In vivo results indicated that HDFs significantly suppressed Th17 cell activation, stimulated T regulatory (Treg) cell expansion, inhibited dendritic cell maturation, reduced microglial activation, and stimulated oligodendrocyte expansion and remyelination. The results also demonstrated that administration of HDFs in the EAE model significantly enhanced Treg-dependent disease inhibition in a manner superior to adipose or bone marrow-derived MSCs. The phase 0/1 primary-safety clinical trial studied a single-dose infusion of allogeneic HDFs into four relapsing-remitting and one secondary progressive MS patients.

The primary outcome of the safety clinical trial indicated a strong correlation for CBC, blood chemistry, and electrocardiogram data for all patients compared with pre-infusion test results, and no adverse events were reported.