Neuraly gets FDA clearance of INDA to initiate phase 2b trial of NLY01 in Alzheimer’s Disease

Neuraly announced it has received clearance of an investigational new drug application (IND) to initiate a Phase 2B trial of NLY01 in patients with Alzheimer’s disease.

NLY01 is also being evaluated in patients with Parkinson’s disease in a Phase 2 trial initiated in February 2020.

“Initiation of this Phase 2 study in Alzheimer’s disease represents an important milestone in the ongoing advancement of NLY01,” said Seulki Lee, Ph.D., President and Chief Executive Officer of Neuraly. “Alzheimer’s has proven to be a particularly challenging disease to address therapeutically. We believe that targeting neuroinflammation via this novel mechanism of action represents a compelling pathway with the potential to be a disease-modifying agent for both Alzheimer’s and Parkinson’s disease.”

NLY01 is a long-acting, glucagon-like peptide 1 receptor (GLP-1R) agonist. In a paper published in Nature Medicine, it was shown that NLY01 binds to upregulated GLP-1R, blocking pathological activation of microglia in animal models of neurodegenerative diseases. The study also showed that by inhibiting glial activation and subsequent pro-inflammatory cytokines, NLY01 prevented neuronal cell death and slowed the motor function decline that was observed in the absence of treatment.

“Our internal studies have confirmed the same mechanism of action underlies the neuroinflammation observed in animal models of Alzheimer’s and Parkinson’s disease,” added Viktor Roschke, Ph.D., Chief Scientific Officer of Neuraly. “These findings reinforce our belief in the potential of NLY01 in treating both of these diseases.”

The Phase 2B Alzheimer’s study is a multicenter, randomized, double-blinded, placebo-controlled trial that is expected to enroll more than 500 patients at more than 100 sites in the US, Canada and Europe. The study is designed to assess the safety, tolerability and efficacy of NLY01 in subjects with mild cognitive impairment due to Alzheimer’s disease. Topline results are expected by Q4, 2023.