CervoMed Inc. (NASDAQ:CRVO) on Monday shared 32-week data from the Extension phase of its Phase 2b RewinD-LB trial evaluating oral neflamapimod in patients with Dementia with Lewy Bodies (DLB).
The initial 16-week, randomized, double-blind, placebo-controlled portion of the study included 159 DLB patients and was followed by a 32-week Extension phase in which all participants received neflamapimod (40mg TID).
Results from the Extension phase showed that neflamapimod continued to slow disease progression and impacted a key plasma marker of neurodegeneration in DLB patients.
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New Data: 32-Week Results from the Extension Phase of the Phase 2b RewinD-LB Trial1
- An older batch of neflamapimod capsules was utilized, which were associated with plasma exposures below the expected and targeted range, while capsules from a new batch of neflamapimod were associated with achieving target plasma concentrations and observing statistically significant clinical benefit.
- Patients treated with New Capsules demonstrated statistically significant slowed disease progression compared to patients treated with Old Capsules.
- Even greater risk reductions were observed in patients with ptau181 < 2.2 pg/mL – the threshold CervoMed believes is the optimal ptau181 threshold for evaluating the presence of AD co-pathology in patients with DLB.
- Researchers also presented data evaluating different cut-off levels of ptau181 based on the 32-week results and assessed the correlation between ptau181 and ptau217, a validated biomarker for AD.
New Data: Reduction in Plasma Levels of Glial Fibrillary Acidic Protein at Week 32 of Extension Phase
- At Week 32 of the Extension phase, there was a statistically significant reduction from baseline in GFAP plasma levels in patients who received New Capsules for all 32 weeks, with a mean change of -18.4±4.0 pg/mL in all participants (N=107) and -21.2±4.4 pg/mL in participants with screening plasma ptau181 below 2.2 pg/mL (N=91).
- Placebo recipients in the initial, double-blind phase of the trial had a mean increase from baseline to Week 16 of +1.1±3.0 pg/mL in all participants (N=74) and +1.1±3.3 pg/mL in the subset with screening plasma ptau181 below 2.2 pg/mL (N=65).
Both Old and New Capsules demonstrated comparable tolerability profiles, and no new safety signals were identified during the Extension phase of the trial.
During the first 16 weeks of the Extension phase, a lower incidence of falls was seen in participants with screening ptau181 < 2.2 pg/mL who received New Capsules of neflamapimod as compared to participants who received either Old Capsules or placebo (vs. Old Capsules, p=0.025; vs. placebo, p=0.007).
Price Action: CRVO stock is up 29.4% at $11.62 at the last check on Monday.
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