8-K: CervoMed Provides Update on Neflamapimod DLB Program at International Conference

CervoMed announced topline results from the blinded phase of its RewinD-LB trial for neflamapimod in dementia with Lewy bodies, noting no significant difference between the drug and placebo, but highlighting potential with a new drug batch.

Summary

• CervoMed presented an update on its neflamapimod development program for dementia with Lewy bodies (DLB) at the 8th International Lewy Body Dementia Conference.
• The topline results from the 16-week double-blind phase of the RewinD-LB trial showed no discernible differences between the neflamapimod 40mg three times daily (TID) dose and the placebo group.
• Analysis suggests that lower-than-expected bioavailability of the drug during the double-blind phase may be due to the age of the drug batch used.
• Pharmacokinetic data from a food effect study in healthy volunteers and within-subject comparisons indicate that a newer batch of capsules achieved targeted plasma concentrations.
• Data from the first 16 weeks of the open-label extension (OLE) phase of the RewinD-LB trial, which includes the newer batch of capsules, is expected in the first quarter of 2025.
• The company believes neflamapimod may still have potential as a treatment for DLB when administered at therapeutically effective levels.

Sentiment

Score: 4

Explanation: The sentiment is moderately negative due to the lack of efficacy in the double-blind phase of the trial, although there is some optimism about the potential of the newer drug batch. The company is still in the early stages of development and faces significant risks.

Positives

• A newer batch of neflamapimod capsules achieved targeted plasma concentrations, suggesting the drug can be effective at the right levels.
• The company believes neflamapimod may still have potential as a treatment for DLB when administered at therapeutically effective levels.
• The open-label extension phase of the trial will provide data on a range of efficacy endpoints with the newer batch of capsules.
• The RewinD-LB trial is funded by a $21.3 million grant from the National Institutes of Health's National Institute on Aging.

Negatives

• The double-blind phase of the RewinD-LB trial showed no significant difference between neflamapimod and placebo.
• Lower-than-expected drug bioavailability during the double-blind phase was a significant issue.
• Measured trough plasma drug concentrations during the double-blind phase were similar to those seen with 40mg twice-daily (BID) dosing in a previous study in Alzheimers Disease, which may explain the lack of efficacy.

Risks

• The company's ability to obtain efficacy endpoint data at the targeted plasma drug concentrations during the open-label extension phase is not guaranteed.
• The company's available cash resources and the availability of additional funds on acceptable terms are a risk.
• The likelihood and timing of any regulatory approval of neflamapimod is uncertain.
• General economic, political, business, industry, and market conditions, inflationary pressures, and geopolitical conflicts could impact the company.

Future Outlook

The company anticipates the next data readout from the first 16 weeks of the open-label extension phase of the trial in the first quarter of 2025, which will include data on a range of global, cognitive and motor efficacy endpoints, as well as pharmacokinetic data.

Management Comments

• After extensive analysis of the clinical and safety data sets and the drug product administered to participants during the double-blind phase of the study, we continue to believe neflamapimod may have potential as a treatment for DLB when administered at a therapeutically effective level, said John Alam, MD, Chief Executive Officer of CervoMed.
• Our next data readout, from the first 16 weeks of the OLE phase of the trial, will be available in the first quarter of 2025 and will include data on a range of global, cognitive and motor efficacy endpoints, as well as pharmacokinetic data, obtained from a sizeable subgroup of participants who are receiving capsules of neflamapimod manufactured more recently than the capsules utilized during the double-blind phase of the study.

Industry Context

The announcement is relevant to the broader pharmaceutical industry focused on neurodegenerative diseases, particularly DLB, where there are limited treatment options. The company is attempting to address a significant unmet medical need.

Comparison to Industry Standards

• The lack of efficacy in the double-blind phase contrasts with the positive results seen in CervoMed's AscenD-LB Phase 2a clinical trial, which showed significant improvements in dementia severity, functional mobility and cognitive performance.
• The company is attempting to address a significant unmet medical need as there are no FDA or European Medicines Agency approved treatments for DLB.
• The current standard of care, cholinesterase inhibitor therapy, is approved for use in Alzheimers disease, but in DLB patients typically improves cognition transiently, and does not impact the motor component of the disease.

Stakeholder Impact

• Shareholders may be concerned about the lack of efficacy in the double-blind phase of the trial.
• Patients with DLB and their families may be hopeful about the potential of neflamapimod, but also cautious given the current results.
• Employees of CervoMed will be focused on the next steps in the development of neflamapimod.

Next Steps

• The company will analyze the data from the first 16 weeks of the open-label extension phase of the RewinD-LB trial.
• The company will evaluate the next steps in the development of neflamapimod based on the data from the open-label extension phase.

Key Dates

Keywords

neflamapimod, dementia with Lewy bodies, DLB, RewinD-LB trial, clinical trial, pharmacokinetics, bioavailability, open-label extension, neurologic disorders, CervoMed