Welcome to this special edition of Neurology News Network. I'm Marco Meglio.
According to a recent company update, the FDA has shared written feedback aligning on key aspects of CervoMed’s proposed phase 3 trial for neflamapimod, an investigational oral therapy for the treatment of patients with dementia with Lewy bodies (DLB), to support a potential new drug application (NDA) submission. The company anticipates receiving feedback from other global regulatory authorities in the coming months and plans to provide additional details on the phase 3 trial design in early 2026 following these interactions. Based on the feedback from the agency, the company plans to initiate a single, global, randomized, double-blind, placebo-controlled phase 3 trial investigating the efficacy and safety of neflamapimod in approximately 300 patients with DLB who meet consensus clinical criteria in the second half of 2026. The study will randomize participants 1:1 to receive either oral neflamapimod or placebo for 32 weeks, followed by a neflamapimod-only extension for 48 weeks.
In recent news, the FDA has issued Biohaven a complete response letter (CRL) for its clinical application regarding troriluzole, an investigational agent for patients with spinocerebellar ataxia (SCA). Troriluzole, a novel, third-generation tripeptide prodrug of riluzole, the FDA-approved drug for ALS, was aiming to become the first approved treatment for SCA, a rare neuromuscular disorder that lacks effective options. According to Biohaven, the reasons behind the CRL were related to issues with the data included in the new drug application (NDA), such as the decision to use real-world data and external controls. Ultimately, the agency felt that this led to potential bias, design flaws, and lack of pre-specification and unmeasured confounding factors. The company is expected to work with the FDA to discuss next steps for the investigational agent in efforts to bring the treatment to the SCA community.
A 2025 prospective study titled Dental Atherosclerosis Risk in Communities (DARIC) found that co-occurring periodontal disease (PD) and dental caries were both independently associated with increased risk of ischemic stroke and major adverse cardiovascular events (MACEs) in US cohorts. The study also reported that poor oral health was linked to these elevated risks, with particularly strong associations observed for increased risks of thrombotic and cardioembolic stroke subtypes in a median 21-year follow up with participants. Senior author Souvik Sen, MD, MS, MPH, a professor of neurology at the University of South Carolina School of Medicine, and his colleagues found that participants with both PD and caries had an 86% higher risk of ischemic stroke, while those with PD alone saw a 44% greater risk compared to participants with good oral health.2 Furthermore, 4% of individuals with good oral health experienced a stroke, compared with 7% of participants with gum disease and 10% of those with both gum disease and caries.
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