Fibrobiologics, a clinical-stage biotechnology company, has announced that it will be presenting preclinical and clinical data at the upcoming Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2024. The company, listed on the NASDAQ under the ticker symbol FBLG, is focused on developing therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials.
The company's research is centered around investigating the therapeutic potential of using allogeneic human dermal fibroblasts (HDFs) as a treatment for multiple sclerosis (MS) through immune modulation and stimulation of myelin expression by oligodendrocytes to rebuild the damaged myelin sheath. Multiple sclerosis is described by the National Institutes of Health as a t-cell-mediated autoimmune disorder that leads to severe and progressive cognitive impairment, sensory deprivation, and weakened coordination.
According to the press release, extensive preclinical studies conducted using allogeneic HDFs in the experimental autoimmune encephalomyelitis (EAE) animal model of MS yielded promising results. In vivo results indicated that HDFs significantly suppressed pathogenic T 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 mesenchymal stem cells (MSCs).
Additionally, 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 indicated a strong correlation for complete blood count (CBC), blood chemistry, and electrocardiogram (ECG) data for all patients compared with pre-infusion test results, and no adverse events were reported.
Dr. Hamid Khoja, Chief Scientific Officer at Fibrobiologics, expressed optimism about the potential of HDFs for the treatment of MS based on the results obtained so far. He stated, “Our in vivo animal studies provided evidence that allogeneic HDFs are capable of suppressing pathogenic T cell activation, stimulating T regulatory (Treg) cell expansion, inhibiting dendritic cell maturation, and stimulating oligodendrocyte expansion and myelin protein expression. Based on our results to date, we are enthusiastic about the promise of HDFs for the treatment of MS, although we understand that further study is required. In pursuit of that goal, Fibrobiologics is designing a phase II clinical trial to study the safety and efficacy profile of various concentrations of HDF spheroids and the effect of multiple-dose treatments over an eighteen-month study period.”
The company's full 8-K submission is available here.
