SARASOTA, FL, July 08, 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 that it has entered into an exclusive, global license agreement with Columbia University to further develop, manufacture, and commercialize its lead drug candidate, SPC-15, an intranasal treatment for stress-induced affective disorders and PTSD.
Silo recently submitted a pre-IND briefing package and meeting request for SPC-15 to the U.S. Food and Drug Administration (FDA) earlier this month. The Company is currently engaged in the final steps required before submission of an IND application to the FDA to begin first-in-human clinical studies. Silo intends to utilize the FDA’s streamlined 505(b)(2) pathway for SPC-15, which would shorten clinical timelines and reduce drug development costs.
“In our opinion, the execution of the exclusive license agreement for our SPC-15 product is a critical step for our Company which we believe could increase shareholder value in the future, subject to FDA approval if and when received,” said Silo CEO Eric Weisblum.
SPC-15 is a novel serotonin 4 (5-HT4) receptor agonist therapeutic for the treatment of PTSD, anxiety, and other stress-induced affective disorders. SPC-15 is being developed as an intranasal medication. If clinically successful, SPC-15 could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval. Silo Pharma is conducting preclinical studies of SPC-15 in collaboration with Columbia University and was granted an exclusive license to further develop, manufacture, and commercialize SPC-15 worldwide.
Silo Pharma Inc. (Nasdaq: SILO) 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 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 universities and independent laboratories. For more information, visit www.silopharma.com and connect on social media at LinkedIn , X , and Facebook .