{"id":850931,"date":"2025-05-14T08:43:06","date_gmt":"2025-05-14T12:43:06","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/silo-pharma-advances-ptsd-drug-spc-15-toward-first-in-human-trial-with-key-safety-study-initiated-at-frontage-laboratories\/"},"modified":"2025-05-14T08:43:06","modified_gmt":"2025-05-14T12:43:06","slug":"silo-pharma-advances-ptsd-drug-spc-15-toward-first-in-human-trial-with-key-safety-study-initiated-at-frontage-laboratories","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/silo-pharma-advances-ptsd-drug-spc-15-toward-first-in-human-trial-with-key-safety-study-initiated-at-frontage-laboratories\/","title":{"rendered":"Silo Pharma Advances PTSD Drug SPC-15 Toward First-in-Human Trial with Key Safety Study Initiated at Frontage Laboratories"},"content":{"rendered":"

\nClear Regulatory Path to Clinical Trials for Intranasal PTSD Therapy Targeting Multi-Billion-Dollar Market
\n<\/h2>\n
\n

SARASOTA, FL, May 14, 2025 (GLOBE NEWSWIRE) — Silo Pharma, Inc. (Nasdaq: SILO) (\u201cSilo\u201d or the \u201cCompany\u201d), a developmental stage biopharmaceutical company focused on novel therapeutics and drug delivery systems, today announced that it has entered into an agreement with Frontage Laboratories, a global full-service CRO (contract research organization), for a Food and Drug Administration (FDA) requested 7-day safety and toxicology large animal study of its lead asset SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD).<\/p>\n

\u201cWe are conducting a 7-day safety and toxicology study to gather additional data that is expected to supplement and reinforce our SPC-15 investigational new drug (IND) application to the FDA,\u201d said Eric Weisblum, CEO of Silo. \u201cWe currently remain on track to begin an FDA submission this year.\u201d<\/p>\n

The Company is currently working on a separate IND-enabling Good Laboratory Practice (GLP) -compliant toxicology and toxicokinetic study of SPC-15.\u00a0 Positive preclinical data from these studies, if achieved, would support an IND submission for SPC-15 in 2025. Should Silo receive approval of the IND, Silo would proceed to a first-in-human Phase 1 clinical trial for SPC-15.<\/p>\n

Columbia University, the Company\u2019s collaboration partner for pre-clinical development, granted Silo an exclusive global license to further develop, manufacture, and commercialize SPC-15 worldwide.<\/p>\n

\n About SPC-15<\/strong>
\n
SPC-15 is an intranasal serotonin 5-HT4 receptor agonist aimed at treating stress-induced psychiatric disorders such as PTSD and anxiety. With its potential eligibility for the FDA\u2019s streamlined 505(b)(2) regulatory pathway, SPC-15 offers a promising approach to accelerate the approval process. Silo Pharma is collaborating with Columbia University to conduct preclinical studies and has exclusive global rights to the development and commercialization of SPC-15.<\/p>\n

\n About Frontage<\/strong>
\n
Frontage Laboratories is a US-based Contract Research Organization (CRO) that was initially established in New Jersey in April 2001 and later relocated to Pennsylvania in 2004. As an FDA-registered and inspected global pharmaceutical development and manufacturing organization, we are headquartered in Exton, PA, with an impressive network of 25 facilities spread across Pennsylvania, New Jersey, Illinois, Ohio, California, Florida, Canada, Italy, and China. We are dedicated to accelerating the development of innovative therapies by providing a broad range of science driven and quality focused services for drug discovery, DMPK, preclinical, formulation development and CTM, Analytical, clinical trials, bioanalytical and commercial-scale manufacturing.<\/p>\n

\n About Silo Pharma<\/strong>
\n
Silo Pharma Inc. (Nasdaq: SILO) is a developmental stage biopharmaceutical company focused on addressing underserved conditions, including stress-induced psychiatric disorders, chronic pain, and central nervous system (CNS) diseases. The Company\u2019s portfolio includes innovative programs such as SPC-15 for PTSD, SP-26 for fibromyalgia and chronic pain, and preclinical assets targeting Alzheimer\u2019s disease and multiple sclerosis. Silo\u2019s research is conducted in collaboration with leading universities and laboratories.\u00a0silopharma.com<\/a><\/p>\n

\n Forward-Looking Statements<\/strong>
\n
This news release contains “forward-looking statements” within the meaning of the \u201csafe harbor\u201d provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified using words \u201ccould\u201d, \u201cbelieve\u201d, \u201canticipate\u201d, \u201cintend\u201d, \u201cestimate\u201d, \u201cexpect\u201d, \u201cmay\u201d, \u201ccontinue\u201d, \u201cpredict\u201d, \u201cpotential\u201d, 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. (\u201cSilo\u201d or \u201cthe Company\u201d) to differ materially from the results expressed or implied by such statements, including the Company\u2019s ability to successfully complete its preclinical studies and generate positive data, the risk that the FDA may not accept or may require changes to the IND, or may not allow the Company to proceed with clinical trials, the risk that the FDA may not approve
SPC-15 on the Company\u2019s expected timeline, or at all, changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company\u2019s technology platforms, retaining and expanding the Company\u2019s customer base, fluctuations in consumer spending on the Company\u2019s 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 press release, whether as a result of new information, future events, or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events except as required by law.<\/p>\n

\n Contact<\/strong>
\n
800-705-0120
investors@silopharma.com<\/a><\/p>\n

\"\"
\n
\n \"\"\n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

Clear Regulatory Path to Clinical Trials for Intranasal PTSD Therapy Targeting Multi-Billion-Dollar Market SARASOTA, FL, May 14, 2025 (GLOBE NEWSWIRE) — Silo Pharma, Inc. (Nasdaq: SILO) (\u201cSilo\u201d or the \u201cCompany\u201d), a developmental stage biopharmaceutical company focused on novel therapeutics and drug delivery systems, today announced that it has entered into an agreement with Frontage Laboratories, a global full-service CRO (contract research organization), for a Food and Drug Administration (FDA) requested 7-day safety and toxicology large animal study of its lead asset SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD). \u201cWe are conducting a 7-day safety and toxicology study to gather additional data that is expected to supplement and reinforce our SPC-15 investigational new drug (IND) application to the … <\/p>\n

Continue reading “Silo Pharma Advances PTSD Drug SPC-15 Toward First-in-Human Trial with Key Safety Study Initiated at Frontage Laboratories”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-850931","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nSilo Pharma Advances PTSD Drug SPC-15 Toward First-in-Human Trial with Key Safety Study Initiated at Frontage Laboratories - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/silo-pharma-advances-ptsd-drug-spc-15-toward-first-in-human-trial-with-key-safety-study-initiated-at-frontage-laboratories\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Silo Pharma Advances PTSD Drug SPC-15 Toward First-in-Human Trial with Key Safety Study Initiated at Frontage Laboratories - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Clear Regulatory Path to Clinical Trials for Intranasal PTSD Therapy Targeting Multi-Billion-Dollar Market SARASOTA, FL, May 14, 2025 (GLOBE NEWSWIRE) — Silo Pharma, Inc. (Nasdaq: SILO) (\u201cSilo\u201d or the \u201cCompany\u201d), a developmental stage biopharmaceutical company focused on novel therapeutics and drug delivery systems, today announced that it has entered into an agreement with Frontage Laboratories, a global full-service CRO (contract research organization), for a Food and Drug Administration (FDA) requested 7-day safety and toxicology large animal study of its lead asset SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD). \u201cWe are conducting a 7-day safety and toxicology study to gather additional data that is expected to supplement and reinforce our SPC-15 investigational new drug (IND) application to the … Continue reading "Silo Pharma Advances PTSD Drug SPC-15 Toward First-in-Human Trial with Key Safety Study Initiated at Frontage Laboratories"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/silo-pharma-advances-ptsd-drug-spc-15-toward-first-in-human-trial-with-key-safety-study-initiated-at-frontage-laboratories\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-05-14T12:43:06+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTQ1MTAxNiM2OTQwMTA2IzUwMDA2OTMzOQ==\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/silo-pharma-advances-ptsd-drug-spc-15-toward-first-in-human-trial-with-key-safety-study-initiated-at-frontage-laboratories\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/silo-pharma-advances-ptsd-drug-spc-15-toward-first-in-human-trial-with-key-safety-study-initiated-at-frontage-laboratories\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Silo Pharma Advances PTSD Drug SPC-15 Toward First-in-Human Trial with Key Safety Study Initiated at Frontage Laboratories\",\"datePublished\":\"2025-05-14T12:43:06+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/silo-pharma-advances-ptsd-drug-spc-15-toward-first-in-human-trial-with-key-safety-study-initiated-at-frontage-laboratories\\\/\"},\"wordCount\":741,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/silo-pharma-advances-ptsd-drug-spc-15-toward-first-in-human-trial-with-key-safety-study-initiated-at-frontage-laboratories\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTQ1MTAxNiM2OTQwMTA2IzUwMDA2OTMzOQ==\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/silo-pharma-advances-ptsd-drug-spc-15-toward-first-in-human-trial-with-key-safety-study-initiated-at-frontage-laboratories\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/silo-pharma-advances-ptsd-drug-spc-15-toward-first-in-human-trial-with-key-safety-study-initiated-at-frontage-laboratories\\\/\",\"name\":\"Silo Pharma Advances PTSD Drug SPC-15 Toward First-in-Human Trial with Key Safety Study Initiated at Frontage Laboratories - 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(Nasdaq: SILO) (\u201cSilo\u201d or the \u201cCompany\u201d), a developmental stage biopharmaceutical company focused on novel therapeutics and drug delivery systems, today announced that it has entered into an agreement with Frontage Laboratories, a global full-service CRO (contract research organization), for a Food and Drug Administration (FDA) requested 7-day safety and toxicology large animal study of its lead asset SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD). \u201cWe are conducting a 7-day safety and toxicology study to gather additional data that is expected to supplement and reinforce our SPC-15 investigational new drug (IND) application to the … Continue reading \"Silo Pharma Advances PTSD Drug SPC-15 Toward First-in-Human Trial with Key Safety Study Initiated at Frontage Laboratories\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/silo-pharma-advances-ptsd-drug-spc-15-toward-first-in-human-trial-with-key-safety-study-initiated-at-frontage-laboratories\/","og_site_name":"Market Newsdesk","article_published_time":"2025-05-14T12:43:06+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTQ1MTAxNiM2OTQwMTA2IzUwMDA2OTMzOQ==","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/silo-pharma-advances-ptsd-drug-spc-15-toward-first-in-human-trial-with-key-safety-study-initiated-at-frontage-laboratories\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/silo-pharma-advances-ptsd-drug-spc-15-toward-first-in-human-trial-with-key-safety-study-initiated-at-frontage-laboratories\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Silo Pharma Advances PTSD Drug SPC-15 Toward First-in-Human Trial with Key Safety Study Initiated at Frontage Laboratories","datePublished":"2025-05-14T12:43:06+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/silo-pharma-advances-ptsd-drug-spc-15-toward-first-in-human-trial-with-key-safety-study-initiated-at-frontage-laboratories\/"},"wordCount":741,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/silo-pharma-advances-ptsd-drug-spc-15-toward-first-in-human-trial-with-key-safety-study-initiated-at-frontage-laboratories\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTQ1MTAxNiM2OTQwMTA2IzUwMDA2OTMzOQ==","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/silo-pharma-advances-ptsd-drug-spc-15-toward-first-in-human-trial-with-key-safety-study-initiated-at-frontage-laboratories\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/silo-pharma-advances-ptsd-drug-spc-15-toward-first-in-human-trial-with-key-safety-study-initiated-at-frontage-laboratories\/","name":"Silo Pharma Advances PTSD Drug SPC-15 Toward First-in-Human Trial with Key Safety Study Initiated at Frontage Laboratories - 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