Silo Pharma secures exclusive license for SPC-14, an Alzheimer's drug, using FDA's 505(b)(2) pathway.

Silo Pharma, Inc., a developmental stage biopharmaceutical company specializing in innovative drug formulations and delivery systems for both traditional and psychedelic treatments, announced today that it has secured an exclusive global license to advance, manufacture, and market its Alzheimer’s drug, SPC-14. Silo plans to leverage the FDA’s expedited 505(b)(2) pathway for SPC-14, aiming to shorten clinical timelines and lower development costs.

“Our exclusive license for SPC-14 presents an opportunity to address a significant unmet medical need. If approved, SPC-14 could offer hope and relief to many patients and families. Early pre-clinical studies have demonstrated stress reduction and cognitive improvement,” said Silo CEO Eric Weisblum. This announcement follows a similar exclusive license agreement for Silo’s lead drug candidate, SPC-15, designed as an intranasal treatment for stress-induced affective disorders and PTSD.

The global market for Alzheimer’s disease therapeutics is projected to exceed $30.8 billion by 2033, growing at a CAGR of 18.8% from 2024 to 2033. The increasing prevalence of the disease among the aging population and advancements in neurological research are expected to fuel market growth.

SPC-14 is a novel treatment targeting the glutamate receptor NDMAR and serotonin type 4 receptor 5HT4 to address cognitive and neuropsychiatric symptoms of Alzheimer’s disease. In recent small animal preclinical studies, SPC-14 showed effectiveness against LH (luteinizing hormone) stress, reducing learned helplessness, perseverative behavior, and hyponeophagia, an anxiety measure.