Takeaways for Clinicians on CYMS101 in Multiple Sclerosis: Hamid Khoja, PhD

WATCH TIME: 3 minutes

“What we’ve seen in our limited clinical trial is that these tolerogenic fibroblasts, or CybroCell, we don’t see any side effects, or we haven’t seen any side effects.”

The use of fibroblast cell technology for treatment of patients with multiple sclerosis (MS) may offer a unique approach, in addition to an approach with an absence of adverse effects (AEs). Hamid Khoja, PhD, chief scientific officer, FibroBiologics, commented on this technology for MS, dubbed CYMS101, which was evaluated in a limited clinical trial that evaluated safety as the primary outcome.

Noting the small scale of the study, Khoja explained that, unlike those treated with humanized monoclonal antibodies—which can have both immediate and long-term AEs—patients treated with a 1-time infusion of CYMS101 did not experience any AEs. Patients enrolled in the safety study were monitored post-infusion for 4 hours and then at 4-week intervals for complete blood count and blood chemistry, where investigators again did not notice a difference. While experts opted for a single dose in the initial study, in the phase 1/2 clinical trial, multiple doses will be assessed, and investigators will look at multiple concentrations of cells to determine efficacy and safety. According to Khoja, FibroBiologics is aiming for a staggered approach to the clinical trial and anticipates filing an investigational new drug application in the third quarter of 2022.