Amplify Bio to complete GLP study of SPC-15 Novel Intranasal Therapeutic
Silo study advances SPC-15 towards first-in-human trial
SARASOTA, FL, June 26, 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 awarded a contract to its contract research organization (CRO) partner AmplifyBio for an investigational new drug (IND)-enabling large animal GLP (Good Laboratory Practice) study of its lead asset, SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD).
The 4-week GLP study will evaluate a 28-day repeat intranasal dosing with a 14-day recovery. In a recent non-GLP small animal dose-ranging study conducted with AmplifyBio, SPC-15 demonstrated rapid absorption with good exposure over a 24-hour period, suggesting a simple once-per-day human intranasal dosing regimen. The Company entered into previous research and development agreements with AmplifyBio in early 2023 and 2022.
“Silo has partnered with AmplifyBio since 2022. Our longstanding collaboration has played a key role in advancing SPC-15 through multiple successful pre-clinical studies. A successful IND large animal GLP study is the final study that should facilitate seeking U.S. Food and Drug Administration (FDA) permission for first-in-human clinical studies in PTSD patients and would constitute a significant milestone achievement for the Company,” said Silo CEO Eric Weisblum.
Silo submitted a pre-IND briefing package and meeting request to the FDA for SPC-15 earlier this month. The IND-enabling GLP toxicology study is part of the final steps required before submission of an IND application to the FDA.
About SPC-15
SPC-15 an intranasal formulation administrated by a patented nose-to-brain device. The drug is a novel serotonin 4 (5-HT4) receptor agonist that utilizes biomarkers for the treatment of PTSD, anxiety, and other stress-induced affective disorders. 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 to further develop, manufacture, and commercialize SPC-15 worldwide.
About Silo Pharma
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.
About AmplifyBio
AmplifyBio is a CRO integrating next-gen technologies to accelerate the development of safe, efficacious therapies. Characterization and manufacturing services combined with safety studies enhance product knowledge and mitigate risks. amplify-bio.com
Forward-Looking Statements
This news release contains "forward-looking statements" within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified by the use of words “could”, “believe”, “anticipate”, “intend”, “estimate”, “expect”, “may”, “continue”, “predict”, “potential”, and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Silo Pharma, Inc. (“Silo” or “the Company”) to differ materially from the results expressed or implied by such statements, including changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company’s technology platforms, retaining and expanding the Company’s customer base, fluctuations in consumer spending on the Company’s products and other factors. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this presentation, whether as a result of new information, future events, or otherwise, after the date of this presentation or to reflect the occurrence of unanticipated events except as required by law.
Contact
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