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Proposal submitted for FDA 505(b)(2) regulatory pathway for SPC-15 approval
Advancing path to IND submission for first-in-human trials
SARASOTA, FL, Sept. 10, 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 the completion of a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) regarding the Company's development plan for SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD) and stress-induced anxiety disorder. The pre-IND meeting was completed through written responses provided by the FDA’s Division of Regulatory Operations for Neuroscience (DRON) - Psychiatry Group.
The primary purpose of the pre-IND meeting was to align with the FDA on the 505(b)(2) regulatory pathway for approval of SPC-15 along with Silo’s proposed plan to support opening an IND. The FDA’s 505(b)(2) drug development route can significantly shorten clinical timelines for FDA approval and reduce drug development costs.
“The FDA provided helpful written responses on our development plan for SPC-15," said Silo CEO Eric Weisblum. “We now have a clear path for advancing our development of SPC-15 into the clinic for in-human trials which will hopefully lead to FDA approval and ultimately allow us to commercialize our patented, cutting-edge intranasal treatment, to the PTSD treatment market.”
Silo is currently conducting a GLP-compliant pharmacokinetic and pharmacodynamic study in advance of an IND submission for a potential first-in-human (FIH) clinical trial of SPC-15. Pre-clinical data to date indicate that SPC-15’s optimized patient safety and therapeutic delivery has additive benefits for combating stress-induced pathophysiology, both at the behavioral and neural levels. Columbia University has granted Silo an exclusive license to further develop, manufacture, and commercialize SPC-15 worldwide.
About SPC-15
SPC-15 is a novel serotonin 4 (5-HT4) receptor agonist that utilizes biomarkers 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.
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.
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
800-705-0120investors@silopharma.com
SP-26 dissolvable ketamine-based injectable implant targets chronic pain and fibromyalgia
Sever Pharma to scale-up extrusion processes and continue analytical testing for novel non-opioid treatment
SARASOTA, FL, Aug. 14, 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 a new agreement with Sever Pharma Solutions for scale-up extrusion of the Company’s SP-26 ketamine-loaded implant therapeutic targeting fibromyalgia and chronic pain. In addition, Sever Pharma Solutions will continue with analytical testing of the ketamine hydrochloride (ketamine HCL) polymer implants using the optimal time-released, dose-controlled formulation previously selected by Silo for continuing pre-clinical studies.
“Sever Pharma Solutions has been our partner for earlier production of the ketamine implants and validation of the delivery system through successful assay testing,” said Silo CEO Eric Weisblum. “We are pleased to continue our collaboration as we move forward with further pre-clinical testing of our novel non-opioid chronic pain therapeutic. This process is expected to bring Silo closer to selecting the optimal final dosage and formulation in SP-26 to be utilized in animal studies
If clinically successful, SP-26 could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval.
About SP-26
Silo’s SP-26 is a ketamine-based injectable dissolvable polymer implant for the treatment of chronic pain and fibromyalgia. The subcutaneous implant is being designed to safely regulate dosage and time release of the pain-relieving treatment.
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 .
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 800-705-0120 investors@silopharma.com
Silo to advance homing peptide development for initial indication in multiple sclerosis
SARASOTA, FL, Aug. 07, 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 agreement with WuXi AppTec (Hong Kong) Limited, a leading global contract research organization (CRO), for a preclinical small animal study of SPU-16, a central nervous system (CNS) homing peptide targeting multiple sclerosis (MS). Silo Pharma is advancing the development of the SPU-16 liposomal homing peptide through a commercial evaluation license and option agreement with the University of Maryland, Baltimore (UMB).
The study will examine the organ/tissue specificity of the SPU-16 peptide in an experimental autoimmune encephalomyelitis (EAE) protocol, is the most commonly used experimental model for MS. The peptide’s proven ability to target inflamed epithelium suggests that it can be used as a targeted drug delivery tool to address inflammation in the spinal cord.
“We are excited to launch this new study of our novel CNS homing peptide under the management of WuXi AppTec, one of the largest CROs in Asia and globally,” said Silo CEO Eric Weisblum.1 “Designed to cross the blood-brain barrier and target damaged tissue and inflammation, SPU-16 has been shown to enhance the therapeutic effect of current and future therapeutics while decreasing the toxicity of the drugs. While we are currently investigating the peptide for MS, it could provide similar benefits for multiple neuroinflammatory pathologies.”
MS, a human inflammatory demyelinating disease, is one of the most widespread disabling neurological conditions of young adults.2 The global multiple sclerosis drugs market size is projected to grow at a compound annual growth rate (CAGR) of 7.9% from $21.2 billion in 2024 to $38.9 billion by 2032.3
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 .
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
800-705-0120 investors@silopharma.com
1 BAIPHARM, Top 10 CROs With the Highest Revenues in 2023, April 20242 Healthline, Multiple Sclerosis: Facts, Statistics, and You3Fortune Business Insights, Multiple Sclerosis Drugs Market Size, Share & Industry Analysis…, July 2024
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