CervoMed Inc. (NASDAQ:CRVO) reported early results from its Phase 2a clinical study evaluating neflamapimod for nonfluent variant primary progressive aphasia (nfvPPA).
The initial 12-week data demonstrated a noticeable drop in a key biomarker associated with nerve cell damage, signaling a positive step for the therapy’s development.
nfvPPA is a rare frontotemporal dementia subtype characterized by slow, effortful speech and grammar errors while single-word comprehension remains intact.
Promising Biomarker Reductions
During the trial’s open-label phase, researchers tracked two specific plasma biomarkers: neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP).
At the study’s start, 72% of the 25 participants showed unusually high NfL levels compared to the general public, while 16% exhibited elevated GFAP.
Over the initial 12 weeks of treatment, patients experienced an average decrease in plasma NfL levels of approximately 3.1 pg/mL. The most significant portion of this decline happened between the sixth and twelfth weeks.
Furthermore, an exploratory review focused on 13 participants who began the trial with NfL levels at or exceeding the median.
This specific group achieved an even greater average NfL reduction of about 5.7 pg/mL over the same period. Meanwhile, GFAP concentrations remained steady throughout these 12 weeks.
Safety and Trial Structure
Patients generally tolerated neflamapimod well, and the medical team identified no new safety concerns.
Only one individual left the study after developing elevated liver enzymes. This patient showed no symptoms or related bilirubin increases, and the enzyme levels returned to normal once treatment ceased.
The comprehensive 36-week Phase 2a trial aims to assess the drug’s safety, physical effects, and clinical benefits in 25 participants. The study begins with a 24-week open-label period where patients take either 40 mg of the medication three times daily or 80 mg twice daily.
Following this phase, the trial transitions into a 12-week withdrawal stage. During this final segment, researchers assign participants equally to either maintain their neflamapimod treatment or switch to a placebo.
CRVO Stock Price Activity: CervoMed shares are trading lower by 19.88% at $2.58 at the time of publication on Monday, according to Benzinga Pro data.
Photo: Billion Photos / Shutterstock
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