{"id":866817,"date":"2025-07-07T08:19:27","date_gmt":"2025-07-07T12:19:27","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/silo-pharma-advances-ptsd-drug-spc-15-toward-planned-2025-ind-submission-with-pre-clinical-study-data-expected-in-q3-2025\/"},"modified":"2025-07-07T08:19:27","modified_gmt":"2025-07-07T12:19:27","slug":"silo-pharma-advances-ptsd-drug-spc-15-toward-planned-2025-ind-submission-with-pre-clinical-study-data-expected-in-q3-2025","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/silo-pharma-advances-ptsd-drug-spc-15-toward-planned-2025-ind-submission-with-pre-clinical-study-data-expected-in-q3-2025\/","title":{"rendered":"Silo Pharma Advances PTSD Drug SPC-15 Toward Planned 2025 IND Submission with Pre-Clinical Study Data Expected in Q3 2025"},"content":{"rendered":"
\n

\n
\n Planned submission of IND application in 2025; Phase 1 clinical trial to follow if IND application approved<\/em>
\n <\/strong>\n <\/p>\n

\n
\n No new PTSD drug approvals in the U.S. in nearly 25 years; large potential addressable market for SPC-15 worldwide<\/em>
\n <\/strong>\n <\/p>\n

SARASOTA, FL, July 07, 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 expects to receive data from the additional preclinical studies of its lead asset SPC-15 within the next 30 to 90 days. SPC-15 is a novel intranasal prophylactic targeting Post-Traumatic Stress Disorder (PTSD).<\/p>\n

The final drug studies are 1) an investigational new drug (IND)-enabling GLP (Good Laboratory Practice)-compliant toxicology and toxicokinetic animal study, and 2) a U.S. Food and Drug Administration (FDA)-requested 7-day safety and toxicology large animal study. Concurrently, a device study of the formulation-specific microchip-based nasal spray system used in SPC-15 is being conducted.<\/p>\n

Early data on SPC-15 indicated that its optimized patient safety profile and therapeutic delivery may provide additive benefits for combating stress-induced pathophysiology at both the behavioral and neural levels.\u00a0<\/p>\n

Eric Weisblum, CEO of Silo, stated, \u201cAs we await pre-clinical data within the next 90 days, we currently anticipate initiating the IND application for SPC-15 before the end of the year, assuming positive data results. If submitted and approved, this will be a pivotal achievement along our path to first-in-human trials. If the FDA approves our IND within the 30-day review period, we could initiate a Phase 1 clinical trial before the end of 2026.<\/p>\n

\u201cMoving forward, we intend to seek the FDA\u2019s 505(b)(2) regulatory pathway for approval of SPC-15, a drug development route that can significantly shorten clinical timelines for FDA approval and reduce drug development costs,\u201d Weisblum added.<\/p>\n

Only two drugs are currently approved by the FDA for treating PTSD, both of which primarily target the depressive effects of the condition. In contrast, SPC-15\u2019s differentiated method of action is designed to increase stress resilience in high-risk populations. There have been no new drug approvals in nearly 25 years for the condition that affects an estimated 3.9% of the world\u2019s population.1<\/sup><\/p>\n

\n About SPC-15<\/strong>
\n
SPC-15 is an intranasal 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 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 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 1<\/sup> FT Specialist, Endpoints in Focus, Lykos\u2019 pain is others\u2019 gain\u2026., June 2024.<\/p>\n

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

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

Planned submission of IND application in 2025; Phase 1 clinical trial to follow if IND application approved No new PTSD drug approvals in the U.S. in nearly 25 years; large potential addressable market for SPC-15 worldwide SARASOTA, FL, July 07, 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 expects to receive data from the additional preclinical studies of its lead asset SPC-15 within the next 30 to 90 days. SPC-15 is a novel intranasal prophylactic targeting Post-Traumatic Stress Disorder (PTSD). The final drug studies are 1) an investigational new drug (IND)-enabling GLP (Good Laboratory Practice)-compliant toxicology and toxicokinetic … <\/p>\n

Continue reading “Silo Pharma Advances PTSD Drug SPC-15 Toward Planned 2025 IND Submission with Pre-Clinical Study Data Expected in Q3 2025”<\/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-866817","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nSilo Pharma Advances PTSD Drug SPC-15 Toward Planned 2025 IND Submission with Pre-Clinical Study Data Expected in Q3 2025 - 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-planned-2025-ind-submission-with-pre-clinical-study-data-expected-in-q3-2025\/\" \/>\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 Planned 2025 IND Submission with Pre-Clinical Study Data Expected in Q3 2025 - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Planned submission of IND application in 2025; Phase 1 clinical trial to follow if IND application approved No new PTSD drug approvals in the U.S. in nearly 25 years; large potential addressable market for SPC-15 worldwide SARASOTA, FL, July 07, 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 expects to receive data from the additional preclinical studies of its lead asset SPC-15 within the next 30 to 90 days. SPC-15 is a novel intranasal prophylactic targeting Post-Traumatic Stress Disorder (PTSD). 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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 expects to receive data from the additional preclinical studies of its lead asset SPC-15 within the next 30 to 90 days. SPC-15 is a novel intranasal prophylactic targeting Post-Traumatic Stress Disorder (PTSD). The final drug studies are 1) an investigational new drug (IND)-enabling GLP (Good Laboratory Practice)-compliant toxicology and toxicokinetic … Continue reading \"Silo Pharma Advances PTSD Drug SPC-15 Toward Planned 2025 IND Submission with Pre-Clinical Study Data Expected in Q3 2025\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/silo-pharma-advances-ptsd-drug-spc-15-toward-planned-2025-ind-submission-with-pre-clinical-study-data-expected-in-q3-2025\/","og_site_name":"Market Newsdesk","article_published_time":"2025-07-07T12:19:27+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTQ4OTk5MCM3MDM0NzI1IzUwMDA2OTMzOQ==","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-planned-2025-ind-submission-with-pre-clinical-study-data-expected-in-q3-2025\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/silo-pharma-advances-ptsd-drug-spc-15-toward-planned-2025-ind-submission-with-pre-clinical-study-data-expected-in-q3-2025\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Silo Pharma Advances PTSD Drug SPC-15 Toward Planned 2025 IND Submission with Pre-Clinical Study Data Expected in Q3 2025","datePublished":"2025-07-07T12:19:27+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/silo-pharma-advances-ptsd-drug-spc-15-toward-planned-2025-ind-submission-with-pre-clinical-study-data-expected-in-q3-2025\/"},"wordCount":729,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/silo-pharma-advances-ptsd-drug-spc-15-toward-planned-2025-ind-submission-with-pre-clinical-study-data-expected-in-q3-2025\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTQ4OTk5MCM3MDM0NzI1IzUwMDA2OTMzOQ==","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/silo-pharma-advances-ptsd-drug-spc-15-toward-planned-2025-ind-submission-with-pre-clinical-study-data-expected-in-q3-2025\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/silo-pharma-advances-ptsd-drug-spc-15-toward-planned-2025-ind-submission-with-pre-clinical-study-data-expected-in-q3-2025\/","name":"Silo Pharma Advances PTSD Drug SPC-15 Toward Planned 2025 IND Submission with Pre-Clinical Study Data Expected in Q3 2025 - 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