CRVO: New Data from Phase 2a Trial Presented at CTAD…
NASDAQ:CRVO
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New Data from Phase 2a Study Presented at CTAD
On October 25, 2023, CervoMed Inc. (NASDAQ:CRVO) announced that Dr. Niels Prins of the Brain Research Center in Amsterdam had given an oral presentation at the 16th Clinical Trials in Alzheimer’s Disease (CTAD) conference that highlighted neflamapimod’s clinical development program and included new analyses from the Phase 2a clinical trial for the treatment of patients with dementia with Lewy bodies (DLB). A copy of the presentation can be found here.
Neflamapimod is the company’s lead development compound that is an oral, highly selective, blood brain penetrant small molecule inhibitor of p38α. It has been studied in multiple clinical trials, including single- and multiple-dose Phase 1 trials in healthy volunteers, Phase 2 studies in rheumatoid arthritis, and most recently in a successful Phase 2 study in patients with DLB that showed improvement versus placebo in cognition, functional, and motor aspects of the disease.
The presentation at CTAD focused on the results of the AscenD-LB Phase 2a trial and how those results were used to design the RewinD-LB Phase 2b trial (NCT05869669). As discussed in our previous report, the company published results of pre-specified analyses showing an association between plasma phosphorylated tau at position 181 (ptau181) levels at the beginning of the study and a patient’s response to neflamapimod. The following table gives an overview of the outcome measurements for the entire Phase 2a study population as well as for those patients without Alzheimer’s disease (AD) co-pathology, as determined through a plasma ptau181 level at the beginning of the study < 2.2 pg/mL.
A recent publication showed that both glial fibrillary acidic protein (GFAP) and neurofilament light chain (NfL) can differentiation mild cognitive impairment due to Lewy bodies from healthy controls, with GFAP being more discriminant (Hamilton et al., 2023). New analyses from the Phase 2a study showed that treatment with neflamapimod reduced GFAP levels compared to placebo in patients without AD co-pathology, as shown in the following figure. From baseline to Week 16, GFAP decreased by mean 10.6 pg/mL in neflamapimod-treated patients compared to an increase by mean 14.1 pg/mL in placebo-treated patients (P=0.04). These results, which are new data that had not been previously reported, reinforce the previously reported evidence showing that neflamapimod acts on the underlying disease process in DLB.
In order to determine the proper sample size for the Phase 2b trial, clinical trial simulations were performed by power analysis. The simulations utilized data from the Phase 2a trial for the major clinical endpoints in patients without AD co-pathology. Based on 100 simulated clinical trials with 80 patients per treatment group (and assuming a 10% dropout rate), there is ~85% power with the NTB, 95% power with TUG, and >95% power (approaching 100%) with CDR-SB to detect a treatment effect at an alpha level of 0.05. The change in CDR-SB in neflamapimod-treated patients compared to placebo-treated patients after 16 weeks is the primary outcome of the Phase 2b trial.
Conclusion
The comprehensive review of the Phase 2a data in the presentation, including the new data regarding the effect on a potential blood biomarker of the disease, strengthens the case for neflamapimod having a substantial and meaningful treatment effect in DLB. CervoMed has set up the RewinD-LB Phase 2b trial to maximize the chance of success through: 1) excluding patients with probable AD co-pathology through evaluation of baseline serum ptau181 levels and 2) power analysis using data from the Phase 2a study to properly power the Phase 2b trial (approaching 100%) for the change in CDR-SB primary endpoint. The trial is continuing to enroll patients, and we currently estimate that enrollment will conclude in the first half of 2024 and topline results will be available in the second half of 2024. With no changes to our model our valuation remains at $17.00 per share.
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