Silo Pharma (NASDAQ: SILO), a developmental-stage biopharmaceutical company focused on developing novel formulations and drug-delivery systems for traditional therapeutics and psychedelic treatments, has submitted a pre-Investigational New Drug (“pre-IND”) briefing package and meeting request to the U.S. Food and Drug Administration (“FDA”). The submission is for Silo Pharma’s intranasal prophylactic treatment for post-traumatic stress disorder (“PTSD”) and stress-induced anxiety disorder: SPC-15. A novel serotonin 4 (“5-HT4”) receptor agonist, SPC-15 is being developed as an intranasal medication and uses biomarkers for the treatment of PTSD, anxiety, and other stress-induced affective disorders. The company also outlined its roadmap for the novel and proprietary intranasal PTSD treatment, which includes a progressive intellectual and neurological deterioration (“PIND”) study as well as a good laboratory practice (“GLP”) study, which are both expected to start in the second half of 2024. “We believe our preclinical work on SPC-15, supported by published preclinical data, provides a strong foundation for our development strategies and initial clinical trial design,” said Silo Pharma CEO Eric Weisblum in the press release. “We anticipate that our pre-IND submission will lead to valuable guidance from the FDA as we prepare for the first-in-human clinical trial of SPC-15 in PTSD.”
To view the full press release, visit https://ibn.fm/8Y5yf
About Silo Pharma Inc.
Silo Pharma is a developmental-stage biopharmaceutical company developing novel therapeutics that address underserved conditions including stress-induced psychiatric disorders, chronic pain conditions and central nervous system (“CNS”) diseases. Silo focuses on developing traditional therapies and psychedelic treatments in novel formulations and drug-delivery systems. The company’s lead program, SPC-15, is an intranasal treatment targeting post-traumatic stress disorder (“PTSD”) and stress-induced anxiety disorders. SP-26 is a time-release, ketamine-loaded implant for fibromyalgia and chronic pain relief. Silo’s two preclinical programs are SPC-14, an intranasal compound for the treatment of Alzheimer’s disease, and SPU-16, a CNS-homing peptide targeting multiple sclerosis (“MS”). Silo’s research and development programs are conducted through collaborations with Columbia University and the University of Maryland, Baltimore. For more information about the company, visit www.SiloPharma.com.
NOTE TO INVESTORS: The latest news and updates relating to SILO are available in the company’s newsroom at https://ibn.fm/SILO
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