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Silo Pharma Announces Pipeline Prioritization for 2024 Targeting Mental Health, Chronic Pain, and Neurology
Preparing Pre-Investigational New Drug Application for lead drug program SPC-15 Company plans to pursue FDA streamlined 505(b)(2) pathway for clinical drug
About this update from Silo Pharma, Inc.
[{"type":"text","content":"Preparing Pre-Investigational New Drug Application for lead drug program SPC-15 Company plans to pursue FDA streamlined 505(b)(2) pathway for clinical drug development SARASOTA, FL, Feb. 01, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced updates for its strategic 2024 focus for its clinical pipeline. The Company is advancing a diversified portfolio of four drugs targeting three health areas: mental health, chronic pain, and neurology. “This year we are prioritizing clinical development of our post-traumatic stress disorder (PTSD) therapeutic, SPC-15, in collaboration with Columbia University, and we plan to submit a Pre-Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) by the end of the second fiscal quarter in 2024,” said Eric Weisblum, CEO of Silo. “Each of our novel therapeutics target underserved diseases with limited treatment options where we believe we can deliver quality medical care and make an impact.” Silo’s lead program, SPC-15, is an intranasal prophylactic treatment for the treatment of PTSD and stress-induced anxiety disorder, an underserved market with few approved drugs. A dose-ranging non GLP study of SPC-15 is in progress, with a final validation report expected in the first half of 2024. With PTSD affecting 3.5%1 of U.S. adults and few approved drugs, SPC-15's method of action could offer a new and much-needed treatment solution. Silo's next prioritized program is SP-26, an innovative non-opioid chronic pain solution, developed as an injectable and dissolvable time-release ketamine-loaded implant for fibromyalgia, utilizing the subcutaneous injection method. As a self-administered treatment, SP-26 holds the potential to be the first at-home ketamine treatment approved for chronic pain management. Silo's collaboration with Columbia University has also produced SPC-14, a nascent Alzheimer’s disease therapeutic. With initial positive results from animal studies and more data expected in 2024, Silo believes SPC-14 represents an encouraging development in Alzheimer’s disease research. SPU-16, targeting multiple sclerosis (MS), is being developed in coll...