Zinger Key Points
- Participants on New Capsules showed a lower increase in dementia severity than those on Old Capsules.
- Chardan upgraded CervoMed to Buy, citing compelling 16-week extension data.
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On Tuesday, CervoMed Inc. CRVO released results from the first 16 weeks of the extension phase of the Phase 2b RewinD-LB study of neflamapimod for dementia with Lewy bodies (DLB).
Of the 159 participants randomized in the initial 16-week double-blind, placebo-controlled (Initial) phase, 152 completed the Initial phase and 149 entered the extension phase (Extension).
Of the 149 participants who entered the Extension, 55 received the same batch of capsules (Old Capsules) utilized in the Initial phase throughout the first 16 weeks of the Extension and 94 received a new batch of capsules (New Capsules).
- From the end of the Initial phase of the study (i.e., Day 1 of the Extension) through to Week 16 of the Extension, the change in CDR-SB (dementia severity) was lower in the New Capsule group compared to the Old Capsule group.
- When analyzed from the study’s baseline through Week 16 of the Extension, the New Capsules demonstrated a positive benefit compared to the placebo.
On CGIC (assess patient’s condition or symptoms), administration of the New Capsules led to an improved score (4.02 vs. 4.46 with Old Capsules, p=0.035), indicating less worsening with New Capsule administration.
Old and New Capsules demonstrated comparable tolerability profiles. No new safety signals were identified during the Extension.
The incidence of falls was lower in participants who received New Capsules than those who received Old Capsules during the Extension.
Chardan Research writes, “While we believe the full 32-week data from OLE will be important for informing the path forward for the program, we find the 16-week OLE data compelling enough to move from the sidelines”.
On Wednesday, analyst Daniil Gataulin upgraded CervoMed from Neutral to Buy and a price target of $14.
Price Action: CRVO stock is up 1.13% at $6.24 at the last check Thursday.
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