Cell Therapy Bemdaneprocel Meets Primary Objective, Retinal Thickness in Parkinson Disease, TERIS Study Findings Published


Neurology News Network for the week ending September 2, 2023. [WATCH TIME: 3 minutes]

WATCH TIME: 3 minutes

Welcome to this special edition of Neurology News Network. I’m Marco Meglio.

New data from a first-in-human phase 1 study assessing bemdaneprocel, an investigational cell therapy, showed that the agent met its primary objective of safety, with encouraging results on other measures of motor and nonmotor outcomes. Based on these results, the companies are planning for a phase 2 trial that is expected to begin enrolling patients in the first half of 2024. In the 5 individuals assigned to the low-dose cohort who completed 1-year follow-up, 31 AEs were reported, all of which were considered mild to moderate in severity except for 1 case of fall. No serious AEs were attributed to bemdaneprocel after 1 year; however, investigators did note 2 unrelated serious AEs of seizure attributed to the surgical procedure and 1 COVID case. Both of these resolved without sequelae. Above, all, there were no AEs reported as possibly related to the cell therapy.

Using data from 2 studies, a cross-sectional analysis showed that individuals with Parkinson disease (PD) have reduced thickness of the inner nuclear layer (INL) and ganglion cell-inner plexiform layer (GCIPL) of the retina. Collectively, these findings strengthened the argument that neurodegenerative pathology in PD involves the GCIPL and INL and that these retinal layers may have prognostic clinical relevance. From the AlzeEye cohort of 154,830 individuals with retinal imagine, there were 700 individuals (0.45%) who had prevalent PD and 105,770 controls. After adjustment for age, sex, ethnicity, hypertension, and diabetes mellitus, individuals with prevalent PD had significantly thinner GCIPL across all parafoveal subfields. Thickness point estimates were most reduced in the inferior subfield and least reduced in the temporal subfield.

Months after initial data was presented at the 2023 American Academy of Neurology Annual Meeting, investigators have published the full dataset of the phase 3 TERIS study showing teriflunomide’s (Aubagio; Sanofi) impact in patients with preclinical demyelinating disease. All told, treatment with the agent resulted in an unadjusted risk reduction of 63% and an adjusted risk reduction of 72% relative to placebo, in preventing first clinical demyelinating event. Led by Christine Lebrun-Frenay, MD, PhD, FAAN, the final analysis featured 89 adults meeting the 2009 radiologically isolated syndrome criteria who were randomly assigned 1:1 to oral teriflunomide (n = 44), 14 mg daily, or placebo (n = 45), for a 96-week treatment period. Patients had the option to continue in the randomization arm for up to 144 weeks. The primary outcome was time to a first acute or progressive neurologic event resulting from central nervous system demyelination, expressed as a rate of conversion to clinical MS.

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