SPC-15 / Silo Pharma - LARVOL DELTA

Silo Pharma Partners with Allucent to Support Planned FDA Investigational New Drug Application for SPC-15 as a Therapeutic for PTSD (GlobeNewswire) - "The Company currently expects to submit the IND in 2026 and commence its first-in-human (FIH) SPC-15 trial subsequent to FDA approval...Silo intends to pursue the FDA’s 505(b)(2) accelerated regulatory pathway for clinical development of SPC-15."

First-in-human • IND • Licensing / partnership • Post-traumatic Stress Disorder

Silo Pharma Adds Japanese Patent to Expanding Global IP Portfolio for Licensed PTSD Drug (GlobeNewswire) - "The patent reinforces protection for Silo’s lead asset, SPC-15, an intranasal treatment targeting post-traumatic stress disorder (PTSD), originally developed by Columbia University."

Patent • Post-traumatic Stress Disorder

Silo Pharma Advances PTSD Drug SPC-15 Toward Planned 2025 IND Submission with Pre-Clinical Study Data Expected in Q3 2025 (GlobeNewswire) - "Planned submission of IND application in 2025...Silo Pharma, Inc...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)...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....'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.'"

IND • New P1 trial • Preclinical • Post-traumatic Stress Disorder

Silo Pharma Secures Biomarker Patent for Novel PTSD Therapeutic SPC-15 as Clinical Trial Nears (GlobeNewswire) - "Silo Pharma, Inc...today announced that the U.S. Patent and Trademark Office (USPTO) had issued a Notice of Allowance for U.S. Patent Application No. 17/954,858 (titled 'Biomarkers for Efficacy of Prophylactic Treatments Against Stress-Induced Affective Disorders') that Silo licenses from Columbia University....The to-be-issued patent will further strengthen Silo’s IP protection for its lead asset, SPC-15, an intranasal treatment targeting post-traumatic stress disorder (PTSD). The patent is expected to issue as U.S. Patent No. 12,329,726 on June 17, 2025."

Patent • Post-traumatic Stress Disorder

Silo Pharma Partners with Resyca for IND-Supporting Intranasal Drug-Device Study of PTSD Drug SPC-15 (GlobeNewswire) - "Silo Pharma, Inc...announced that it has entered into a service agreement with medical technology provider Resyca BV for a drug-device study of the formulation-specific microchip-based nasal spray system used in its lead asset SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD)...This study is expected to provide the final necessary device data and documentation for SPC-15’s IND, which we plan to submit to the FDA this year"

IND • New trial • Post-traumatic Stress Disorder

Silo Pharma Achieves Key Milestone with First Dosing in IND-Enabling GLP Study for SPC-15 as a Groundbreaking PTSD Treatment (GlobeNewswire) - "Silo Pharma, Inc...today announced first dosing in an investigational new drug (IND)-enabling GLP (Good Laboratory Practice)-compliant toxicology and toxicokinetics study of its lead asset, SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD)....Silo Pharma completed a pre-IND meeting in September 2024 to align with the FDA on the 505(b)(2) regulatory pathway for approval of SPC-15 and review the Company’s proposed plan to support opening an IND."

FDA event • Preclinical • Post-traumatic Stress Disorder

Silo Pharma Granted U.S. Patent for Novel Intranasal Post-Traumatic Stress Disorder Treatment (GlobeNewswire) - "Silo Pharma...announced that the U.S. Patent and Trademark Office (USPTO) issued an Issue Notification for our previously filed patent application (No. 17/954,864) titled 'Pharmacological Prophylactics Against Stress-Induced Affective Disorders in Females'. The projected patent number is 12,239,614 and the issue date of such patent will be March 4, 2025. The patent reinforces protection for Silo’s lead asset, SPC-15, an intranasal treatment targeting post-traumatic stress disorder (PTSD). The patent includes newly added claims to U.S. Patent 11,491,120, which was issued to Silo in November 2022."

Patent • Post-traumatic Stress Disorder

Silo Pharma Expands Intellectual Property Portfolio with Provisional Patent Filing for Innovative SPC-15 Combination Treatment (GlobeNewswire) - "Silo Pharma...announced the filing of a provisional patent application with the U.S. Patent and Trademark Office (USPTO) for its lead asset SPC-15. Silo currently has patents issued and numerous expanded patent applications pending for SPC-15, a technology that was originally licensed through a collaboration with Columbia University. The provisional patent covers a dual-action method and composition for combating stress-induced pathophysiology and reducing a variety of stress-induced psychiatric behaviors."

Patent • CNS Disorders • Psychiatry

Silo Pharma Advances Intellectual Property Portfolio with Provisional Patent Filing for PTSD Treatment (GlobeNewswire) - "Silo Pharma, Inc...today announced the filing of a provisional patent application with the U.S. Patent and Trademark Office (USPTO). This application, focused on its lead asset SPC-15, highlights Silo’s commitment to advancing treatments for stress-induced psychiatric disorders, including post-traumatic stress disorder (PTSD). The provisional patent covers the chronic, combinatorial targeting of N-methyl-D-aspartate receptors (NMDARs) and serotonin type IV receptors (5-HT4Rs) to extend behavioral effects against stress-induced perseverative behavior and hyponeophagia."

Patent • CNS Disorders • Post-traumatic Stress Disorder

Silo Pharma Awarded US Patent for Groundbreaking PTSD Treatment and Prepares for SPC-15 Clinical Trial (GlobeNewswire) - "Silo Pharma, Inc...announced that the U.S. Patent and Trademark Office (USPTO) issued a Notice of Allowance for patent application 17/954,864 for 'Pharmacological Prophylactics Against Stress-Induced Affective Disorders in Females.'...The patent, when formally approved, will reinforce protection for Silo’s lead asset, SPC-15, an intranasal treatment targeting post-traumatic stress disorder (PTSD). The patent includes newly added claims to U.S. Patent 11,491,120, which was issued to Silo in February 2023."

Patent • Post-traumatic Stress Disorder

Silo Pharma Partners with AmplifyBio to Advance SPC-15 for PTSD and Anxiety (GlobeNewswire) - "Silo Pharma, Inc...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)....Silo submitted a pre-IND briefing package and meeting request to the FDA for SPC-15 earlier this month."

FDA event • Licensing / partnership • CNS Disorders • Post-traumatic Stress Disorder

Silo Pharma Completes Successful Dose-Ranging Study of SPC-15 Intranasal Therapeutic for PTSD (GlobeNewswire) - "Silo Pharma, Inc...announced positive results from its non-GLP small animal dose-ranging study of SPC-15, an intranasal prophylactic treatment for anxiety and post-traumatic stress disorder (PTSD)....Data analysis demonstrated rapid absorption of SPC-15 with good exposure over a 24-hour period, suggesting a once-per-day human intranasal dosing regimen would be optimal....'We are currently on track to submit a pre-investigational New Drug Application (IND) to the FDA by the end of the second quarter 2024'."

IND • Preclinical • CNS Disorders • Post-traumatic Stress Disorder

Silo Pharma to Initiate Dose-Ranging Study of Novel Intranasal Therapeutic SPC-15 for the Treatment of PTSD (GlobeNewswire) - "Silo Pharma, Inc...announced plans to initiate a dose-ranging study of its targeted prophylactic treatment SPC-15 for the treatment of post-traumatic stress disorder (PTSD). The study will identify the maximum tolerated intranasal dose of the drug and pharmacokinetic in small animals to determine the therapeutically relevant dose range....The final validation report is expected in 2024."

New trial • CNS Disorders • Post-traumatic Stress Disorder

Silo Pharma’s SPC-15 Awarded U.S. Patent Protecting Ongoing R&D of Therapeutic for Stress-Induced Affective Disorder and Alzheimer’s Disease (GlobeNewswire) - "Silo Pharma, Inc...announced that the U.S. Patent and Trademark Office (USPTO) has issued U.S. Patent 11,622,948 titled 'Biomarkers for Efficacy of Prophylactic Treatments Against Stress-Induced Affective Disorders.' The new patent claims cover the use of biomarkers in determining the efficacy of the Company’s portfolio drug SPC-15, a targeted prophylactic treatment utilizing ketamine compositions, as a method of treatment for a stress-induced affective disorder or stress-induced psychopathology....Silo Pharma owns an option to license certain assets of which the patent forms a part currently undergoing studies at Columbia University for stress-induced affective disorders and Alzheimer's disease."

Patent • CNS Disorders • Mood Disorders • Psychiatry

"$SILO Silo Pharma Commences Formulation for SPC-15 Targeting Anxiety and PTSD Stress-Related Disorders https://t.co/gh8SPDGV2O" (@stock_titan)

CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder • Psychiatry

Partial Substitution of Fish Meal with Soy Protein Concentrate on Growth, Liver Health, Intestinal Morphology, and Microbiota in Juvenile Large Yellow Croaker (Larimichthys crocea). (PubMed, Aquac Nutr) - "The present study investigated the growth performance, feed utilization, intestinal morphology, and microbiota communities of juvenile large yellow croaker (Larimichthys crocea) fed diets containing different proportions of soy protein concentrate (SPC) (0, 15%, 30%, and 45%, namely FM, SPC15, SPC30, and SPC45) as a substitute for fish meal (FM) for 8 weeks...Tyzzerella could be the bacteria indicator of intestinal in large yellow croaker fed low quality diet due to high SPC content. Based on the quadratic regression analysis of WG, the best growth performance could be observed when the replacement of FM with SPC was 9.75%."

Journal • Gastrointestinal Disorder